Clinical Research Directory

Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)

The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the HBR-ARC criteria and HIR defined as ABCD-GENE score ≥10) following PCI. We hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.

Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry

Percutaneous coronary intervention (PCI) of complex coronary bifurcation lesions frequently requires an upfront two-stent strategy. While the double kissing crush technique has been extensively studied, limited contemporary data are available comparing alternative two-stent approaches, particularly Minicrush and T-stenting and Culotte, in complex bifurcation anatomy. This study aimed to compare procedural characteristics and long-term clinical outcomes of Minicrush versus Culotte stenting techniques in patients undergoing PCI for complex coronary bifurcation lesions.

The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance

Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend. New strategies are needed to help more patients attend cardiac rehabilitation. In this study, the investigators will see if using an $50 incentive, case management, text messages, and physical activity coaching combined into a single intervention will help more patients attend cardiac rehabilitation. In preparation for a larger trial, patients will also be randomly assigned to four different ways of seeking their permission to be in a research study. The investigators will see if these approaches affect how many people participate in the research project. The two main goals of this study is to understand: 1. If the consent approach type impacts participation rates in the research study 2. If the multi-component intervention (case management, financial incentives, text messages, and physical activity coaching) improves cardiac rehabilitation participation within 3 months.

Trends and Risk Factors of Adverse Cardiovascular and Cerebrovascular Events After Primary PCI

This single-center, ambispective cohort study will use real-world data from Zhongshan Hospital, Fudan University. About 8,000 patients aged 18 years or older with acute myocardial infarction (AMI) who underwent primary percutaneous coronary intervention (PCI) from 2009 to 2028 will be included. Patients will be grouped into four periods: 2009-2013, 2014-2018, 2019-2023, and 2024-2028. The study aims to describe 20-year trends in in-hospital events and major adverse cardiovascular and cerebrovascular events (MACCE) within 2 years after PCI and to identify independent risk factors. The primary outcome is MACCE within 2 years, defined as a composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. Key secondary outcomes include in-hospital all-cause death, impaired myocardial perfusion, malignant arrhythmia, acute heart failure, recurrent myocardial infarction, non-fatal ischemic stroke, and bleeding events. Data will come from electronic medical records and the cardiac catheterization database.

Hybrid Percutaneous Coronary Intervention Combining a Bioresorbable Scaffold With Drug-coated Balloons Versus a Conventional Drug-eluting Stent-based Strategy in Patients With Long and Diffuse Coronary Artery Disease

The primary objective of the study is to assess the safety and the efficacy of a hybrid percutaneous coronary intervention (PCI) strategy combining a magnesium-based sirolimus-eluting bioresorbable scaffold (Freesolve, Biotronik AG, Switzerland) and ≥1 paclitaxel-eluting drug-coated balloon(s) (Pantera Lux, Biotronik AG, Switzerland) compared to a conventional DES-based PCI approach using \>1 newer-generation drug-eluting stents (Orsiro Mission, Biotronik AG, Switzerland) for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI with respect to vessel-level absolute change in non-invasive angiography-derived fractional flow reserve (FFRangio, CathWorks, Newport Beach, USA) between post-index PCI and 12-month follow-up. BIOHYBRID is a coronary revascularization strategy study comparing two contemporary treatment approaches for patients with long and/or diffuse coronary artery lesions undergoing PCI. The primary hypothesis of the study is that a hybrid PCI strategy using a 'leave nothing behind' or 'metal-free' approach that combines a bioresorbable magnesium scaffold and drug-coated balloons for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI is feasible. The secondary hypothesis is that a hybrid PCI strategy combining a bioresorbable magnesium scaffold and drug-coated balloons is non-inferior to a conventional DES-based PCI approach using one or several DES for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI with respect to vessel-level absolute change in FFRangio (CathWorks, Newport Beach, USA) between post-index PCI and at 12 months of follow-up.

Investigation to Assess the Effects of Drug-COATED Balloons for Treatment of Plaques Erosions Causing Acute Coronary Syndromes

Drug eluting balloon angioplasty might be a better alternative than medical treatment or stenting in subjects with plaque erosion, which is the second most common cause of myocardial infarction. The main objective of this pilot study is to gain clear insights on the effect of percutaneous coronary intervention (PCI) with size matched DCB (SeQuent) as compared to treatment with GP IIbIIIa inhibitor or heparin \& dual antiplatelet therapy in a predominantly Caucasian population at 2 days and at 1 year after the procedure.

Cold-Region Exposure and Cardiac Remodeling After PCI

This multicenter prospective observational cohort study aims to investigate the association between cumulative cold-region exposure and adverse left ventricular remodeling and cardiovascular outcomes in patients with coronary artery disease undergoing successful percutaneous coronary intervention (PCI). Individual-level chronic cold exposure will be quantified primarily by cumulative months of residence, work, or other relevant exposure in cold regions during the 3 years preceding PCI. Additional exposure measures will include regional cold-wave days derived from meteorological records and winter outdoor occupational exposure. Participants will undergo baseline cardiovascular magnetic resonance (CMR), echocardiography, electrocardiography, and clinical and laboratory assessment after PCI. Echocardiography will be repeated at 6 months to assess left ventricular remodeling. Cardiovascular events will be prospectively collected during follow-up. The study will evaluate whether cumulative cold-region exposure is associated with distinct CMR phenotypes, adverse left ventricular remodeling, and major adverse cardiovascular events (MACE), and whether cold-exposure measures provide incremental prognostic information beyond conventional clinical, imaging, and electrocardiographic risk markers.

A Study on the Development and Application of a Cardiac Rehabilitation Nursing Intervention Protocol for Patients With First-Episode Acute Myocardial Infarction Following PCI, Based on a Socio-Ecological Theory Model

The purpose of this \[Study Type: Clinical Trial\] is to investigate whether a cardiac rehabilitation nursing intervention based on the socio-ecological model can improve rehabilitation-related outcomes in patients. The study population consists of \[adult patients with acute myocardial infarction who have undergone percutaneous coronary intervention (PCI)\]. The primary research questions addressed in this study are: 1. Can a social-ecological model-based cardiac rehabilitation intervention improve adherence to cardiac rehabilitation among patients with myocardial infarction following PCI?\] 2. Can a social-ecological model-based cardiac rehabilitation intervention improve cardiac function and quality of life among patients with myocardial infarction following PCI?\] The researchers will compare the \[intervention group and the control group\] to observe whether there are \[group differences in cardiac rehabilitation adherence, cardiac function, and quality of life levels\]. Intervention group: Receives routine cardiology care combined with a social-ecological model-based cardiac rehabilitation intervention (1. In-hospital guidance; 2. Multidimensional, continuous rehabilitation support at home and in the community; 3. Regular follow-up assessments, etc.); Control Group: Received routine care from the cardiology department and standard discharge cardiac rehabilitation education; All participants completed questionnaire surveys and had cardiac function-related indicators collected at baseline, 3 months into the intervention, and 6 months into the intervention.

Clinical Study of Coronary Extension Catheter

This prospective, multicenter, single-arm study plans to enroll 69 subjects. Subjects meeting the protocol criteria will receive treatment with coronary extension catheters. The safety and efficacy of these catheters in percutaneous coronary intervention will be assessed through the collection and analysis of efficacy and safety endpoints during treatment and follow-up.

BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation

The purpose of the BRIDGE study is to learn whether supplementing traditional center-based cardiac rehabilitation (CBCR) with a mobile health technology intervention can help patients monitor their health, stay engaged in healthy lifestyle behaviors, better manage cardiovascular risk factors, and improve overall health outcomes. Cardiac rehabilitation is an evidence-based outpatient program designed to help people recover from heart-related conditions through supervised exercise, education, counseling, and support for healthy lifestyle changes. Although cardiac rehabilitation is highly recommended and beneficial, many patients do not receive the full benefits of the program. Some patients attend fewer sessions than recommended, and many find it difficult to maintain healthy habits outside of the clinic, such as regular physical activity, heart-healthy eating, taking medications as prescribed, monitoring blood pressure, and managing weight. This study will test whether combining CBCR with mobile health tools may improve participation and support healthy behaviors at home. Mobile health tools include mobile phone applications, connected devices such as a weight scale, blood pressure monitor, and activity tracker, as well as personalized text messages designed to encourage and support healthy self-care. This study will help determine whether these mobile health tools can make cardiac rehabilitation more effective and help patients maintain healthy behaviors beyond the clinic setting.

Revascularization of Calcified Coronary Arteries

The primary aim of this study is to evaluate changes in absolute coronary flow and pressure before and after percutaneous coronary intervention in calcified lesions. The secondary aim is to use a machine learning model to predict the outcome of the intervention.

Serpentine vs Traditional Hydrophilic Guidewire Tracking in Complex Radial Anatomy

Coronary angiography and angioplasty are commonly performed through the radial artery. In some patients, anatomical variations of the radial and brachial arteries, such as loops, increased tortuosity or sharp angulations may pose challenges to equipment advancement. Both the hydrophilic guidewire 0,035'' approach and the "Serpentine" technique have been described in the literature as techniques for overcoming radial anatomical challenges, with the hydrophilic guidewire approach being the more commonly used method. In practical terms, both techniques involve the use of the same standard materials, with differences relating mainly to operator handling and technical manipulation. This study does not introduce any experimental device, material, or treatment; instead, it aims to compare the established approach using a 0.035'' hydrophilic guidewire with the emerging " Serpentine" technique with respect to effectiveness, procedural time, and safety.

Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)

This first in human feasibility study is designed to evaluate the feasibility MD-SBA DES in subjects undergoing percutaneous coronary intervention (PCI) to treat bifurcation lesions.

Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation on Alleviating Major Depressive Disorder in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention:A Prospective, Double-Blind,Randomized Controlled Study

This is a randomized, controlled study. ACS follow- up patients aged 18 to 80 years old with hemodynamic stability, who are 14 days to 1 year after PCI, are screened through the HAMD score and the HAMA score. Patients with a HAMD score greater than 7 points and a HAMD score higher than that of the HAMA, are included in this study. Patients were allocated to the active taVNS group or sham taVNS group with a 1:1 ratio. Both groups received the stimulation for 20 minutes each time, twice a day with an 8-week treatment and a 8-week follow-up. All treatments were self-administered by the patients at home after they received training from the hospitals. The primary observation endpoints include the depression scores of the HAMD. The secondary observation endpoints include the HAMA 、GAD、 response and remission rates of HAMD ，as well as the PCL-C for post-traumatic stress disorder. We also observed the cardiac function indexes measured by echocardiography and the B-type natriuretic peptide .

Advanced Invasive Diagnosis Strategy for Post-PCI Patients With Stable Coronary Syndromes Undergoing Coronary Angiography

AID Post-PCI Angina is as an observational, prospective, single-cohort, multicenter study designed to investigate the causes and origins of post-PCI angina by using the advance invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP) in an all-comers population of patients with post-PCI angina referred for invasive coronary angiography. An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI), who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography (ICA) will be enrolled. ICA will be performed with the application of the structure AID strategy to evaluate both obstructive and non-obstructive cause of myocardial ischemia. Then, angiography derived physiological assessment of epicardial coronary artery using functional coronary angiography in each vessel will be performed in both index procedure and the previous procedure in all patients. By combining information obtained from both procedures, the causes and origins of post-PCI angina will be made. Treatment will be decided by the operators according to the result. Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline and at 1, 6, and 12 months after the procedure. The main hypothesis of this study states that, in patients with post-PCI angina referred to ICA, the application of the structured AID strategy combining with angiography derived physiology (ADP) will lead to a high diagnostic yield in identifying the origins of obstructive disease and causes of post-PCI angina.

OPtimal stEnt Deployment stRategy oF Contemporary sTents - Registry to Evaluate Percutaneous Coronary Intervention Using Bioresorbable Scaffolds With Thinner-strut Construction and Guidance by intracOronary Imaging to REduce Scaffold Failure

Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic local inflammation which may lead to in-stent restenosis, absence of physiological coronary vasomotion and vessel caging which makes future coronary artery bypass grafting (CABG) impossible. A bioresorbable scaffold (BRS) is designed to overcome these limitations. The first generation BRS was shown to be clinically inferior to DES due to a slightly higher rate of stent thrombosis. To overcome this problem, several scientific developments have been achieved in the past few years, such as thinner BRS strut construction and improved implantation technique by using PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). A PCI protocol that combines implantation of a second generation thin-strut BRS, mandatory PSP implantation method and mandatory intracoronary imaging-guidance has not yet been investigated. The aim of this study is to investigate feasibility of a new PCI protocol with implantation of the second generation Meres100 thin-strut BRS combined with a protocolized PSP implantation technique guided by intracoronary imaging.

Use of Various Types of Introducers in Conventional Radial Access

The purpose of this intervention study is to compare different types of radial introducers used in traditional radial access in terms of the incidence of complications. The main questions it aims to answer are: 1. Does a smaller outer diameter of the introducer reduce the risk of complications associated with radial access? 2. Does the presence of an outer hydrophilic coating on the introducer reduce the risk of complications associated with radial access? 3. Does the use of an introducer with a smaller outer diameter and an outer hydrophilic coating reduce the risk of complications associated with radial access? The researchers will compare the number of complications associated with radial access when using conventional diameter, uncoated radial introducers, conventional diameter introducers with an outer hydrophilic coating, or reduced outer diameter introducers with an outer hydrophilic coating. During the scheduled revascularization procedure, the participants will undergo radial artery catheterization using one of the types of introducers. Complications from the radiation access will be recorded by doctors within 72 hours after the intervention.

CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China

This is a prospective, multicenter, observational registry designed to evaluate clinical outcomes in patients undergoing complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) in China. Eligible patients will be adults with complex coronary artery disease and severely reduced left ventricular function, or reduced left ventricular function with severe mitral regurgitation, who are considered by the heart team to have an indication for coronary revascularization but are at high risk for coronary artery bypass grafting or decline surgical revascularization. The registry will collect baseline clinical characteristics, coronary angiographic and procedural data, use of intravascular imaging or physiological assessment, revascularization strategy, mechanical circulatory support, peri-procedural complications, laboratory and echocardiographic data, and follow-up outcomes. The primary endpoint is all-cause mortality at 1 year after PCI. Secondary endpoints include major adverse cardiovascular events, cardiac death, myocardial infarction, target vessel revascularization, heart failure hospitalization, major bleeding, and quality-of-life measures. The study also aims to identify prognostic factors and develop a risk prediction model for patients undergoing CHIP-PCI.

Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation

Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined. The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant. In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events. In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").

Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone

The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon \[DCB\] strategy with bail-out BioResorbable Scaffold \[BRS\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction \[NSTEMI\] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are: DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy? Participants will be followed at: 1. st FU visit - 1 month (in hospital) 2. nd FU visit - 6 months (telephone) 3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint 4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy 5. th FU visit - 730 days±30 days (telephone call) - 2Y 6. th FU visit - 1095 days±30 days (telephone call) - 3Y 7. th FU visit - 1460 days±30 days (telephone call) - 4Y 8. th FU visit- 1825 days±30 days (telephone call) - 5Y

Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).

The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.

Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)

Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight. Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS). Study design: Open-label, single-centre, randomized controlled trial. Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome. Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin. Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.

AGECTO Study: PCI vs. Optimal Medical Therapy for CTO in the Octogenarian Patients

The study compares an interventional strategy (PCI) with optimal medical therapy (OMT) in ultra-octogenarians with chronic total occlusions (CTO). Results suggest that successful PCI leads to significant improvements in symptoms and quality of life compared to OMT alone. While initially carrying higher procedural risks, CTO-PCI is considered feasible and safe in experienced centers. There is also potential for long-term benefits in survival and a reduction in major adverse cardiovascular events (MACE). The choice between treatments depends on an individual risk-benefit assessment, considering the patient's overall condition.

Drug Coated Balloon vs. Drug-eluting Stent in Patients With Coronary Artery Disease

Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. This target trial emulation aims to compare clinical outcomes between DCB angioplasty and conventional DES implantation in de-novo coronary lesions in patients with coronary artery disease.