Comparing two methods for heart artery treatment in patients with coronary disease
ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease
This study is testing which method of guiding heart artery treatment works better for patients with coronary artery disease by comparing two different approaches during their procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2400 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 17 sites (Anyang and 16 other locations) |
| Trial ID | NCT05529459 on ClinicalTrials.gov |
What this trial studies
This study compares the clinical outcomes of two different guidance methods for complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention with drug-eluting stents. It is a prospective, multicenter, open-label, randomized trial where patients will be assigned to either quantitative coronary angiography (QCA)-guided or fractional flow reserve (FFR)-guided strategies. Eligible patients will have significant stenotic lesions and will be monitored for outcomes based on the chosen intervention method. The study aims to determine which guidance method leads to better clinical results.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 19 and older with significant coronary artery lesions suitable for percutaneous coronary intervention.
Not a fit: Patients with chronic total occlusions or those who have had previous coronary artery bypass graft surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with coronary artery disease by identifying the most effective revascularization strategy.
How similar studies have performed: Other studies have explored similar approaches in coronary interventions, but this specific comparison of QCA versus FFR guidance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men or women between the ages of 19and older * Typical chest pain or objective evidence of myocardial ischemia suitable for PCI Significant lesions with a diameter stenosis of 50-90% in major epicardial coronary arteries ≥ 2.25 mm in diameter by visual estimation. * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: * Coronary lesions resulting in the expected inability to perform FFR (ex, severe tortuosity or extreme angulation of the vessels) * Chronic total occlusion * Failed PCI of severe stenotic (diameter stenosis \> 90%) or ACS culprit lesions * Previous PCI within 6 months before the index procedure * Previous coronary artery bypass graft surgery * Cardiogenic shock or hemodynamic instability * Left ventricular dysfunction (ejection fraction \< 35%) * Life expectancy \< 1 years for any non-cardiac or cardiac causes * Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure * A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer * Patient's pregnant or breast-feeding or child-bearing potential. * A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor) * Hypersensitivity or contraindication to DES material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated * Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study * Unwillingness or inability to comply with the procedures described in this protocol
Where this trial is running
Anyang and 16 other locations
- Hallym University Sacred Heart Hospital — Anyang, South Korea (Not_yet_recruiting)
- Bucheon Sejong Hospital — Bucheon-si, South Korea (Not_yet_recruiting)
- Inje University Busan Paik Hospital — Busan, South Korea (Recruiting)
- Gyeongsang National University Changwon Hospital — Changwon, South Korea (Recruiting)
- Chungbuk National University Hospital — Cheongju-si, South Korea (Recruiting)
- Daegu Veterans Hospital — Daegu, South Korea (Recruiting)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
- Gangneung Asan Hospital — Gangneung, South Korea (Recruiting)
- Wonkwang University Hospital — Iksan, South Korea (Recruiting)
- Kwangju Christian Hospital — Kwangju, South Korea (Recruiting)
- Inje University Pusan Paik Hospital — Pusan, South Korea (Recruiting)
- Bundang CHA Hospital — Seongnam, South Korea (Not_yet_recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
- Veterans Hospital Service Medical Center — Seoul, South Korea (Recruiting)
- The Catholic University of Korea, ST. Vincent's Hospital — Suwon, South Korea (Not_yet_recruiting)
- Pusan National University Yangsan Hospital — Yangsan, South Korea (Not_yet_recruiting)
Study contacts
- Principal investigator: Seung-Whan Lee, Investigator — Asan Medical Center
- Study coordinator: Jiwon Baek, RN
- Email: cvcrc22@amc.seoul.kr
- Phone: 82230107267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.