Clinical Research Directory

Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection

Acute DeBakey type I aortic dissection (ATAD) is one of the most lethal surgical emergencies. The conventional operative strategy is hemiarch replacement under cardiopulmonary bypass support to replace the diseased segment of the ascending aorta. However, in patients with dissection involving the whole aortic arch and descending thoracic aorta, the presence of the persistently perfused false lumen can lead to late aneurysm formation and require a second-stage operation, and this reduces long-term survival. In the surgical literature, there is growing evidence that the presence of Distal Anastomosis New Entry (DANE), which is a new intimal defect related to the trauma created by surgical sutures, is associated with persistent perfusion of the false lumen, aortic size growth, and the need of re-operation. The Ascyrus Medical Dissection Stent (AMDS; Artivion, Atlanta, Georgia, USA) is a hybrid prosthesis with a proximal sewing collar and distal nitinol self-expanding un-covered stent system designed to reduce the occurrence of DANE and hopefully depressurize the false lumen and lead to remodeling of the aortic wall. The investigators plan to prospectively recruit consecutive patients with acute ascending thoracic aortic dissection patients (Excluding DeBakey II) and randomized them, after informed consent, into either the conventional hemiarch replacement group (Hemiarch-C) or the hemiarch replacement plus AMDS implantation group (Hemiarch-AMDS). The participating team will collect pre-operative, intra-operative and post-operative clinical and radiological parameters for two groups of patients. Written informed consent, specifically allowing the use of clinical records for this randomized study, will be obtained from every patient prior to data collection. Complete DICOM image files of the CT scans will be evaluated by two independent fully qualified Radiologists. Our primary outcome is the radiological detection of DANE in Hemiarch-C and Hemiarch-AMDS groups within the 12-month follow-up period. This study will be the world's first randomized control trial in ATAD to compare the prevalence of DANE in Hemiarch-C and Hemiarch-AMDS. It could be a guideline-changing study for the treatment of ATAD and its impact on the immediate survival, second-stage treatment, and long-term survival of patients suffering from ATAD.

Hemiarch vs Extended Arch in Type 1 Aortic Dissection

HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.

Cerebral Protection in Aortic Arch Surgery

Aortic arch repair surgery is a technically complex and challenging procedure to treat aortic pathologies. Despite advancements in perioperative care, detrimental neurological complications occur during or after surgery. The neurological complications increase the economic burden of healthcare, morbidity and quality of life for the patients, even if they survive. Stroke, for example, leads to an increase in healthcare and social care costs, requiring a subsequent lengthy rehabilitation. Milder neurological impairments include transient ischaemic attacks, confusion and delirium, necessitating longer intensive care and hospital stay. Currently applied cerebral monitoring modalities are electroencephalogram and cerebral oximetry. However, they are not specific enough to timely detect early cerebral ischaemia to prevent neurological complications. S100B protein and neuron-specific enolase are serum markers that reflect cerebral damage, however, their applicability in the hyperacute setting is limited. However, rapid measurements of glial fibrillary protein have paved new pathways to detect cerebral injury. Recent studies reveal more sensitive biomarkers of glucose, lactate, pyruvate, glutamate and glycerol. These biomarkers could potentially detect cerebral ischaemia on a near real-time basis using the microdialysis method. The aim of the project is to develop a bedside system for early detection of cerebral ischaemia on a near real-time basis during aortic arch surgery. Early detection of cerebral ischaemia could mandate more aggressive cerebral protection strategies by further optimisation of hypothermia and antegrade selective cerebral perfusion during surgery, and optimisation of blood pressure and oxygenation in the intensive care unit. Ultimately, early detection of cerebral ischemia during surgery will prevent disabling and costly neurological complications following surgery.

Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection

This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ketorolac in 1,346 patients with Stanford Type A aortic dissection, conducted between 2025 and 2028. Participants will receive either ketorolac (60 mg intramuscularly \[IM\] within 6 hours before surgery and 30 mg im twice daily（at 6:00 AM and 6:00 PM, respectively for two days postoperatively or placebo in addition to standard care. Study outcomes include composite clinical endpoints, postoperative complications, and adverse events, which will be assessed through clinical evaluations, laboratory testing, and imaging studies at predefined intervals up to 90 days. The objective of this trial is to determine whether perioperative administration of ketorolac improves clinical outcomes in this patient population.

Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)

A Multicenter, Randomized Controlled Study About the Safety and Efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for Chronic Aortic Dissection . (GALLANT Study)

Nordic Consortium for Acute Type A Aortic Dissection-2

The Nordic Consortium for Acute Type A Aortic Dissection-2 (NORCAAD-2) is a multicenter research collaboration involving up to 19 units in the Nordic countries and one in The Netherlands. All patients referred for this condition is included, to outline detailed preoperative characteristics and risk factors as well as, for those operated, data on the operative procedure, the postoperative course including major and minor complications and, as the primary interest, mortality in short- and long-term perspective. The need for further procedures on the aorta will also be studied. Acute type A Aortic Dissection (ATAAD) is a vascular emergency with very high case-fatality rate. The condition is realtively infrequent, and single units can rarely amass sufficient number of patients during a reasonable time to analyse also unusual variants in background, presentation, and management. Randomized controlled trials are unlikely, and large multicenter databases are the best source of knowledge for the foreseeable future. Other such databases exist, but NORCAAD-2 is more focused (only ATAAD) and more detailed than many counterparts, with the ability to extract unique information. NORCAAD-2 is the extension and expansion of the original NORCAAD project. NORCAAD-2 includes more centers, more patients, more data and utilizes a novel on-line common database designed for the purpose. The ultimate goal is to identify novel risk markers to help inform decisions on pre-emptive surgery (before ATAAD occurs); to outline superior perioperative techniques and strategies to optimize outcomes both short- and long-term; and to analyze variables related to major complications, in an effort to further reduce their incidence.

GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections

To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.

PregnAncy-Related Aortic DISsEction in China

A multicenter observational study on pregnancy-related aortic dissection

Current Status and Determinants of Care for Patients With Acute Chest Pain in China: A Retrospective Analysis of Data From the China Chest Pain Center Registry

Chinese Cardiovascular Association is an association dedicated to establishing Chest Pain Centers in hospitals that have basic qualifications and meet pre-designed quality control targets.The vision of Chinese Cardiovascular Association is the cardiovascular health of every Chinese, and the mission is to realize the early arrival of the inflection point of cardiovascular events in China.The institute of China Heart House is responsible for the daily management and implementation of Chinese Cardiovascular Association and the implementation and management of the Chest Pain Center construction project.In order to improve standard treatment and chest pain system management to achieve better outcomes for patients, China Heart House established the chest pain center database.The database includes patients in 6000 registered hospitals in 31 provinces in China who have been admitted with chest pain.The database can reflect the clinical characteristics, treatment and outcome of patients with chest pain in China. This non-interventional, retrospective study analyzed the chest pain center database to understand the demographics, clinical characteristics, treatment patterns and clinical outcomes of patients with chest pain, and to analyze the effects of different treatment patterns, including chest pain centers and related collaborative treatment networks.The results of the study will assess the gap between the real-world situation and the recommendations of the guidelines and reflect the effect of chest pain centers and related collaborative treatment networks on the treatment process and service quality.The research results can be directly translated into the basis of medical treatment system intervention, and also provide decision-making reference for improving the evaluation standards and quality control of chest pain centers.

Evaluation of the GORE® Ascending Stent Graft

The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.

Optimal Strategy for Repair of Type A Acute Aortic Dissection

Acute type A aortic dissection (TAAD) persists as a clinicopathologic entity with high lethality in the current era. Several procedures are presently used to repair the TAAAD. The objective of this study is to analyze two groups of individuals using a conservative approach through root-sparing and hemiarch techniques in patients who are hospitalized in higher-risk clinical conditions or more aggressive procedures such as root replacement and total arch replacement in low-risk patients.

Repair Versus Non-repair of the Aortic Arch in Type A Aortic Dissection

Acute Stanford type A aortic dissection (TAAD) is a life-threatening clinical status requiring surgery that is usually performed as a salvage procedure.We planned a multicenter study to evaluate the balance between the patient's condition and those therapeutic strategies that may limit the risk of late adverse events in patients who will be underwent surgery for appropriate management of TAAD

Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery

The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery. Specifically, this research aims to investigate differences in pressure injury outcomes before and after the intervention, and to assess the preventive effectiveness of soft foam dressings as an adjunctive skin-protection strategy.

ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection

Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft

Endovascular Treatment of Thoracic Aortic Disease

The purpose of this study is to assess the role endovascular therapy to treat aortic disease involving the ascending aorta, the aortic arch, and the visceral segment of the aorta (or thoracoabdominal aorta)

Cardiovascular Health Improvement Project

The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls.

Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection

Aortic dissection is a life-threatening condition caused by a tear in the internal layer of major artery wall (aorta) that carries blood to all body organs, resulting in separation of the aortic wall layers (dissection). The dissected aorta compromises blood flow to any organ, and eventually leads to organ damage (Malperfusion Syndrome). Our goal in this project is to use Intravascular Ultrasound (IVUS) to have real time assessment and confirm any evidence of malperfusion syndrome in the setting of aortic dissection after repairing the original aortic tear. IVUS is a small ultrasound (sound waves) wand that is attached to the top of a thin tube. This tube is inserted into the aorta from the groin. This device takes pictures of the aorta and its major branches, to identify problems with blood flow. Having this real-time and dynamic assessment will help to identify any malperfused organs before leaving the operating room and allow us to address the malperfusion syndrome as quickly as possible to limit complications. Without this technique, identifying the problem can take several days after surgery at which point there can be irreversible complications.

Valved Graft PMCF Study

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.

Nutritional Ketosis Marfan

In this pilot clinical trial, the investigators will test whether a carefully supervised ketogenic diet can safely help people with Marfan syndrome who already have a chronic or residual aortic dissection. Fifteen participants will work with a study coordinator and dietitian to learn how to follow the diet and will have regular guidance and check-ins. The participants will measure their blood ketone levels at home with a simple finger-stick device and relay their readings to the research team. Every three months, blood samples will also be collected to confirm the body's level of ketosis. Participants will continue their usual heart and blood-pressure medicines and regular visits with their doctors. Standard of care computed tomography (CT) scans of the aorta will be performed at the start of the study and then again at 6 and 12 months to see if the aorta changes in size. The main goal is to see how many patients can avoid needing aortic surgery within one year, compared with what is normally expected from past studies. The investigators will also track how well patients follow the diet, how their aorta changes, and whether inflammation in their blood decreases.

False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study

To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.

False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)

To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.

Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection

The objective of this registry is to collect information on the performance and clinical benefits of the AMDS (Ascyrus Medical Dissection Stent) to treat patients with acute "DeBakey type I dissections" and with or without so called "preoperative clinically relevant malperfusion" and/or "intramural hematomas". In a healthy aorta (the vessel that supplies blood to most of the body) the blood flows freely through the main lumen (a space inside the vessel where blood flows). The participants involved in this study have a tear that has separated the inner layer of the aorta wall and created a secondary channel (false lumen) in addition to the main channel (true lumen), and huts, the blood flows through both channels. AMDS is a stent (a metal tube helping to keep the vessel open) that is placed in the descending thoracic aorta. AMDS is a medical device commercially available in the countries in which the study is being conducted and it is used as standard of care according to its indication.

Thoraflex Hybrid and Relay Extension Post-Approval Study

The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.