Clinical Research Directory

Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions

Coronary artery disease is a leading cause of mortality and morbidity globally. The left coronary artery system is critically important due to its supply of a large area of myocardium. Ostia lesions of left anterior descending artery \[LAD\] and circumflex artery \[CX\]) present technical challenges during percutaneous coronary intervention (PCI) and are considered high-risk lesions due to their anatomical location, relationship with the left main coronary artery bifurcation. Two main approaches exist for treating these lesions: accurate ostial stenting and crossover stenting extending from the left main coronary artery to the relevant branch. Accurate ostial stenting aims to avoid unnecessary stenting of the left main coronary artery, while crossover stenting is more advantageous in terms of ensuring complete coverage of the ostial region. However, the crossover approach may have disadvantages such as larger stent implantation and potential side branch involvement. The current literature does not clearly define the clinical superiority of these two strategies. While various studies have shown no significant difference in mortality, myocardial infarction, and target lesion revascularization, the results are heterogeneous, and a definitive consensus has not been reached. The majority of current data are based on retrospective or observational studies. Therefore, well-designed prospective studies comparing crossover stenting and accurate ostial stenting strategies in the ostial left-sided coronary artery (LAD and CX) lesions are needed. This planned study aims to contribute to this gap in the literature by comparing the clinical outcomes of the two approaches.

Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL)

This randomized multicenter trial compares coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in 358 patients with ischemic left ventricular dysfunction and multivessel coronary disease. The study evaluates differences in survival, major cardiovascular events, and quality of life over 4 years, and contributes to the international STICH 3.0 collaboration assessing long-term outcomes.

Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.

The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural, imaging, and economic outcomes of patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary artery disease. Coronary artery calcification represents one of the main determinants of procedural complexity and adverse outcomes in contemporary interventional cardiology. Despite the increasing availability of advanced calcium-modification technologies and intracoronary imaging techniques, evidence regarding the optimal treatment strategy in real-world clinical practice remains limited, particularly among high-risk and complex patients often underrepresented in randomized trials. The OROBICA Registry aims to systematically collect longitudinal data from all-comer patients treated for severely calcified coronary lesions using contemporary PCI strategies, including intracoronary imaging guidance (IVUS/OCT), rotational atherectomy, orbital atherectomy, intravascular lithotripsy, specialty balloons, and combined calcium-modification approaches. The primary objective is to assess clinical and procedural outcomes, with particular focus on target vessel failure (TVF). Secondary and exploratory objectives include evaluation of procedural success, imaging findings, predictors of adverse outcomes, healthcare resource utilization, and economic impact associated with the treatment of calcified coronary lesions. The registry is designed as a flexible research platform intended to support future hypothesis-generating analyses and provide real-world evidence to improve personalized management strategies for calcified coronary artery disease.

Coroflex® ISAR NEO PMCF Study

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease

The goal of this clinical trial is to test whether adding coronary function testing and starting targeted medical treatment for identified vasomotor disorders will also improve angina symptoms and quality of life in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention. The main question it aims to answer is: Does performing coronary function testing in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention lead to better relieve of angina symptoms and improvement in quality of life? Researchers will compare this group undergoing coronary function testing with a control group who will solely undergo percutaneous coronary intervention. Participants will: * Undergo percutaneous coronary intervention and coronary function testing in the intervention arm * Undergo percutaneous coronary intervention in the control arm

A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease

The study is a Phase 2a, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the pharmacodynamics (PD), safety and pharmacokinetics (PK) of multiple doses of SRSD107 in participants with coronary arterial disease (CAD) and/or peripheral arterial disease (PAD) with aspirin as background concomitant therapy.

Stenting Versus Drug Eluting Balloons Only in Treatment of Coronary Bifurcation Lesion (ROBUST Study)

The goal of this clinical trial is to learn immediate and follow up results of percutaneous treatment of coronary bifurcation lesion using drug eluting balloons (DEB) only in patients with chronic coronary syndrome (CCS). Researchers will compare endovascular treatment using solely DEB to stenting of coronary bifurcation lesion. The main questions it aims to answer are: * What is immediate and follow up clinical and angiographic results of endovascular treatment of coronary bifurcation lesion using DEB in patients with CCS? * Is efficacy and safety of endovascular treatment of coronary bifurcation lesion using DEB only in patients with CCS non inferior to compare stenting of aforementioned lesion which is contemporary recommended standard of care? Participants will: * Take prescribed medication before and after initial procedure during whole observation period (12 months) * Visit the clinic at 1, 6 and 12 months after the initial procedure for checkup, noninvasive tests and control angiography at 12 months follow up * Inform researchers about all adverse events that might be occur during follow up observation period

Validation of Remote Photoplethysmography (rPPG)-Derived Cardiovascular Parameters Against Standard Clinical Measurements and Risk Scores in a Community

The goal of this observational study is to evaluate whether a contactless camera-based technology, called remote photoplethysmography (rPPG), can accurately measure cardiovascular parameters and estimate cardiovascular risk in adults aged 30 years and older living in a community setting in Semanan, Jakarta. This study aims to determine if rPPG can be used as a simple and accessible tool for early cardiovascular screening. The main questions it aims to answer are: 1. Do cardiovascular parameters measured using rPPG (such as blood pressure, heart rate, and cardiac workload) agree with standard clinical measurements? 2. Do cardiovascular risk estimates generated by rPPG (such as ASCVD risk and Framingham heart age) correspond to risk calculations obtained using conventional clinical and laboratory methods? Researchers will compare results obtained from rPPG-based facial video scans with results from standard medical assessments, including blood pressure measurements, heart rate evaluation, and laboratory tests for cholesterol levels, to determine the level of agreement and accuracy. Participants will: 1. Undergo a short facial video scan (approximately 30-60 seconds) using an rPPG-based system 2. Receive standard clinical assessments, including blood pressure and heart rate measurements 3. Provide basic health information (such as age, sex, smoking status, and treatment history) Undergo simple laboratory testing for cholesterol levels This study is expected to help determine whether rPPG can be used as a reliable, non-invasive, and scalable screening tool for cardiovascular risk in community and primary healthcare settings.

Examining the Effects of Video-Assisted Discharge Education After Coronary Artery Bypass Graft Surgery on Patient Satisfaction and Anxiety

This study was conducted to examine the effects of standard and individualized video-assisted discharge education on patient satisfaction and anxiety levels following Coronary Artery Bypass Graft (CABG) surgery. Prior to the initiation of the study, ethical approval was obtained from Hasan Kalyoncu University and the relevant healthcare institutions. The study was carried out with a total of 120 patients who had undergone CABG surgery and were hospitalized in the Cardiovascular Surgery departments of Gaziantep Dr. Ersin Arslan Training and Research Hospital and Gaziantep City Hospital. The patients were randomly assigned into three groups: a control group, a standard video-assisted education group, and an individualized video-assisted education group. Data were collected using the Patient Information Form, the Patient Education Satisfaction Scale, and the State-Trait Anxiety Inventory (STAI). The data were analyzed using SPSS version

Multi-Omics-Based Novel Thrombosis and Bleeding Markers and Risk Model for CHD

Patients with coronary heart disease who take dual antiplatelet therapy face two serious risks: thrombosis and major bleeding. This study aims to develop better ways to predict these risks and guide personalized treatment. The investigators will use a large, long-term follow-up study of Chinese patients with coronary heart disease. This research plans to discover new biomarkers related to clot and bleeding risk. The study will combine information from proteins, metabolites, sugars attached to proteins, genes, and medical images. Using machine learning methods, the investigators will identify the most important markers and test them in the patient group of this study. The investigators will then build new risk prediction models that include these new markers together with traditional risk scores (such as GRACE, PARIS, and Precise-DAPT). This study will check whether these new models are better than existing ones at predicting who will develop clots or bleeding and at helping doctors decide on the best treatment for each patient. The new aspects of this research are: (1) using advanced multi-omics technology to find novel markers specifically for Chinese patients; (2) combining clinical, biological, and imaging data to improve prediction accuracy; and (3) using machine learning to create more precise risk models. The goal is to provide doctors with a more accurate tool to assess each patient's risk of clots and bleeding. This will help them choose the safest and most effective antiplatelet treatment, reduce serious complications, and improve patient care.

Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy

This study evaluates whether fexuprazan is effective in preventing upper gastrointestinal bleeding and related upper gastrointestinal clinical events in high bleeding risk patients who require dual antiplatelet therapy after coronary stent implantation. A total of 400 participants at a single center will be randomly assigned in a 1:1 ratio within 48 hours after stent implantation to receive either fexuprazan 40 milligrams or lansoprazole 30 milligrams once daily for 6 months. The study will compare upper gastrointestinal clinical events during follow-up

Improved Management of Patients With Recent-Onset Stable Chest Pain

In Germany, coronary CT offers an accurate and less burdensome alternative to cardiac catheterisation for evaluating suspected coronary artery disease, but it is still underused. The IMPRO stepped-wedge trial tests a new, nationwide care model (NVF) in 16 regions to improve guideline-based intersectoral implementation of coronary CT and assess its impact on cardiovascular outcomes and healthcare costs. If effective, the model of care (NVF) could be adopted across Germany to enhance care quality while reducing unnecessary procedures and expenses.

AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease

The AERO CAD study is a prospective, multi-center, single-arm, post-market clinical investigation evaluating the procedural performance and clinical outcomes of the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System in patients with calcified coronary artery disease undergoing percutaneous coronary intervention (PCI). The study will enroll up to 200 subjects across up to 8 U.S. sites. The primary objective is to generate real-world evidence on device performance and clinical outcomes, including target lesion failure at 30 days and procedural success.

Analysis of ECGio to Predict Coronary Stenosis Against a Mixed Reference Standard

The study objective is to evaluate the effectiveness of the ECGio algorithm in predicting clinically significant coronary artery disease . ECGio's diagnostic performance during the trial will be compared against an objective performance ¬criteria using a mixed reference standard of quantitative coronary angiography and quantitative coronary computed tomography angiography in patients a general adult population under suspicion of coronary artery disease.

Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions

The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting stent.

The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI

The objective of Heartflow's NAVIGATE-PCI Registry is to collect observational data about the management of patients before and after deployment of Heartflow's PCI Navigator.

Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia in Patients With Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass

This study compares ketamine/fentanyl versus ketamine/lidocaine in term of their impact on cerebral perfusion during CABG. No prior data address these effects, and the goal is to identify the induction regimen that better preserves cerebral oxygenation.

Drug-coatEd Balloon Multicentric Registry in Spain and PORTugal

Drug-eluting stents (DES) have been the main treatment option for coronary angioplasty (PCI) for many years. The antiproliferative drug in DES has the effect of preventing in-stent restenosis, which is typically a consequence of intimal hyperplasia, a characteristic phenomenon of bare metal stents (BMS). DES have shown to be safe and effective in many clinical and anatomical scenarios. There are, however, several caveats to DES, like restenosis, thrombosis, accelerated atherosclerosis, impossibility of surgical revascularization and disruption of vessel dynamics. These phenomena have a very meaningful negative impact on patient outcomes. Drug-coated balloons (DCB) may avoid those limitations of DES and are an appealing alternative in many different scenarios. They have been the mainstay treatment of in-stent restenosis (ISR) and were formally recommended for this setting in internationally, although recent guidelines recommend DES over a DCB for a first DES restenosis. There is, however, solid evidence for their use in the context of any ISR (BMS or DES-related) and both comparing with POBA or DES. The presence of metal from previous stents makes the implantation of more stents even more of a thing to avoid. High bleeding risk may also be an advantageous setting for DCB, as it may allow for a shorter or less intensive anti-thrombotic treatment with the same or even improved safety endpoints when compared to BMS or DES with standard therapy. Other than ISR, there are other particularly appealing anatomical settings for DCBs such as bifurcations, small vessels and diffuse disease. In the setting of a bifurcation where only the side branch is to be treated, there is evidence that DCB is a good option and provides significantly less late luminal loss when compared to POBA. In case a stent is used in the main branch, a DCB is also a good option for the side branch. In small vessels (\<3,0mm), in which the stent metal would be more conspicuous relative to the smaller lumen, there is strong evidence pointing to a benefit of DCB when compared to balloon angioplasty (POBA) and results at least as good as full-DES. A similar MACE rate between DCB and DES has been reported, with a benefit for DCB in terms of bleeding. In fact, also in larger vessels, DCB may lead to similarly good outcomes. DCB (alone or in combination with DES) is a good alternative to DES-only in diffuse disease. Provided that a good lesion preparation is achieved and there is no structural compromise to the vessel, the lack of a metal stent will be of benefit for any type of lesion. It will contribute to late lumen enlargement (LLE), which can happen in 40-56% of lesions treated with DCB7 and is associated with layered plaques by OCT and medial dissection after lesion preparation. Evidence for DCBs is increasing in different anatomical and clinical contexts, and there are some dedicated recommendations and consensus regarding their use. There is some data regarding real-world clinical performance of DCBs, but there is still the need for large real-world studies with different DCBs, techniques, clinical settings and anatomical contexts with long term follow-up, which is the main driver for this registry.

Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions

The aim of this study is to evaluate the long-term efficacy and safety of drug-coated balloon (DCB) strategies, including DCB alone or hybrid strategies of DCB and drug-eluting stent (DES), compared to DES-only in patients with chronic total occlusion (CTO) after successful recanalization. Through a prospective, multicenter randomized controlled trial, we will directly compare the long-term outcomes of these two treatment strategies in CTO patients to fill the gap in existing research regarding direct comparative data between DCB and DES in CTO treatment. This study expects to provide high-quality evidence for optimizing CTO treatment, potentially improving treatment strategies in complex cases, reducing stent usage, lowering the risk of complications, and ultimately enhancing patient prognosis.

"Erectile Function After PCI in MI and Non-MI Patients"

The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. By doing this, we try to compare patients' responses to PCI after having a heart attack and stable angina to see the real effect of myocardial infarction on erectile function status in the long term by comparing it with a very similar group.

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.

Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease

This is a prospective, observational, single-center study. The main purpose of this study is to explore the predictive value of three coronary vessel-ultrasonic flow ratio (3V-UFR) for major adverse cardiovascular events (MACE) in patients with coronary artery disease within one year. The study will be conducted in Fuwai Hospital, and a total of at least 494 patients with all the three coronary vessel diameter stenoses ≥30% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS). IVUS imaging will be sent to an independent core laboratory for offline UFR calculation. Subsequently, a one-year follow-up was conducted on the patients. The primary endpoint was MACE within one year, which included cardiac death, any myocardial infarction, and ischemia-driven coronary revascularization. The association between the 3V-UFR (low 3V-UFR and high 3V-UFR grouped by median of 3V-UFR) and MACE is investigated, to determine its role in clinical prognosis for patient with coronary artery disease.

Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.

This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.

Feasibility Study SA of the Supira System for HRPCI

The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).