Actively Recruiting
ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease
Led by Seung-Whan Lee, M.D., Ph.D. · Updated on 2025-01-10
2400
Participants Needed
17
Research Sites
186 weeks
Total Duration
On this page
Sponsors
S
Seung-Whan Lee, M.D., Ph.D.
Lead Sponsor
B
Biotronik Korea Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two different strategies for complete revascularization in patients with significant coronary artery disease (CAD) who are undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The study compares quantitative coronary angiography (QCA)-guided anatomic complete revascularization and fractional flow reserve (FFR)-guided physiologic complete revascularization. This prospective, multicenter, randomized trial includes patients with symptoms or evidence of myocardial ischemia and specific stenotic lesions in major coronary arteries. Participants are randomly assigned to either the QCA-guided group, where PCI is performed on lesions with at least 50% diameter stenosis, or the FFR-guided group, where PCI targets lesions with FFR values of 0.80 or less. Imaging guidance during PCI is optional but left to the operator's discretion, while routine high-pressure post-dilation is recommended. The study involves an initial procedure with possible staged procedures as needed. Participants will be followed clinically at 1, 6, and 12 months, and then up to 5 years after the initial procedure. Assessments include tracking death, myocardial infarction, unplanned repeat revascularization, bleeding, rehospitalization, and self-rated health. The study aims to collect data on these outcomes to compare the two revascularization strategies in terms of safety, efficacy, and cost-effectiveness over both short- and long-term periods.
CONDITIONS
Brief Title
Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 19 years or older
- Typical chest pain or objective evidence of myocardial ischemia suitable for PCI
- Significant lesions with 50-90% diameter stenosis in major epicardial coronary arteries at least 2.25 mm in diameter by visual estimation
- Patient or guardian agrees to study protocol and clinical follow-up schedule with written informed consent
You will not qualify if you...
- Coronary lesions preventing FFR measurement due to severe vessel tortuosity or angulation
- Chronic total occlusion
- Failed PCI of severe stenotic or acute coronary syndrome culprit lesions
- Previous PCI within 6 months before the index procedure
- Previous coronary artery bypass graft surgery
- Cardiogenic shock or hemodynamic instability
- Left ventricular ejection fraction below 35%
- Life expectancy less than 1 year from any cause
- Planned surgery requiring general anesthesia or stopping antiplatelet therapy within 12 months after procedure
- Diagnosis or treatment of active cancer within past 3 years (except superficial skin cancers)
- Pregnancy, breastfeeding, or childbearing potential
- Known intolerance to antiplatelet agents such as aspirin, clopidogrel, prasugrel, or ticagrelor
- Hypersensitivity or contraindication to drug-eluting stent materials
- Any clinically significant abnormality that precludes safe study completion
- Unwillingness or inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Index procedure with possible planned staged procedures over a short period
Participants undergo percutaneous coronary intervention (PCI) guided either by quantitative coronary angiography (QCA) or fractional flow reserve (FFR) to achieve complete revascularization of coronary lesions.
1 index procedure visit and possible additional procedure visits
Duration - Up to 5 years after the index procedure
Participants are followed clinically to monitor health outcomes after PCI.
Visits at 1 month, 6 months, 12 months, and annually up to 5 years
Trial Site Locations
Total: 17 locations
1
Hallym University Sacred Heart Hospital
Anyang, South Korea
Not Yet Recruiting
2
Bucheon Sejong Hospital
Bucheon-si, South Korea
Not Yet Recruiting
3
Inje University Busan Paik Hospital
Busan, South Korea
Actively Recruiting
4
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Actively Recruiting
5
Chungbuk National University Hospital
Cheongju-si, South Korea
Actively Recruiting
6
Daegu Veterans Hospital
Daegu, South Korea
Actively Recruiting
7
Keimyung University Dongsan Medical Center
Daegu, South Korea
Actively Recruiting
8
Gangneung Asan Hospital
Gangneung, South Korea
Actively Recruiting
9
Wonkwang University Hospital
Iksan, South Korea
Actively Recruiting
10
Kwangju Christian Hospital
Kwangju, South Korea
Actively Recruiting
11
Inje University Pusan Paik Hospital
Pusan, South Korea
Actively Recruiting
12
Bundang CHA Hospital
Seongnam, South Korea
Not Yet Recruiting
13
Asan Medical Center
Seoul, South Korea
Actively Recruiting
14
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
15
Veterans Hospital Service Medical Center
Seoul, South Korea
Actively Recruiting
16
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, South Korea
Not Yet Recruiting
17
Pusan National University Yangsan Hospital
Yangsan, South Korea
Not Yet Recruiting
Research Team
J
Jiwon Baek, RN
S
Seung-Whan Lee, Investigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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