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ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease
This study is to compare clinical outcomes between quantitative coronary angiography-guided anatomic complete revascularization and fractional flow reserve-guided physiologic complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention with drug eluting stent
This is a prospective, multicenter center, open-label, randomized trial to compare QCA-guided versus FFR-guided CR strategies in patients with significant CAD who are undergoing PCI with DES. Patients with symptoms or evidence of myocardial ischemia are eligible for enrollment if there have stenotic lesions with a diameter stenosis of 50%-90% in major epicardial coronary arteries ≥ 2.25 mm in diameter by visual estimation, and CR is expected to be achievable by PCI. The detailed information for inclusion and exclusion criteria is described below in the session 4. Patients meeting inclusion criteria without any exclusion criteria will be randomized to either QCA-guided CR or FFR-guided CR group. In the QCA-guided CR group, PCI will be performed if there are lesions with diameter stenosis ≥ 50% by QCA during the index procedure (and, if necessary, planned staged procedure). In the FFR-guided CR group, FFR is measured for the target coronary lesions, and then PCI will be performed for the lesions with FFR ≤0.80. Post-PCI FFR measurement is strongly recommended. However, additional procedures are not recommended based on post-PCI FFR value because there is no consensus of the optimal cut-off value to define physiologic CR. In both QCA-guided and FFR-guided PCI groups, imaging guidance during PCI is left at the discretion of the operator. However, routine high pressure post-dilation with noncompliant balloons is recommended to achieve optimal stent expansion with minimal residual stenosis (diameter stenosis \< 10% on visual estimation). Patients will be followed clinically at 1, 6, 12 months, and then upto 5 years after the index procedure
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
Hallym University Sacred Heart Hospital
Anyang, South Korea
Bucheon Sejong Hospital
Bucheon-si, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Daegu Veterans Hospital
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Wonkwang University Hospital
Iksan, South Korea
Kwangju Christian Hospital
Kwangju, South Korea
Start Date
March 13, 2023
Primary Completion Date
December 31, 2026
Completion Date
July 31, 2030
Last Updated
January 10, 2025
2,400
ESTIMATED participants
Percutaneous Coronary Intervention
PROCEDURE
Lead Sponsor
Seung-Whan Lee, M.D., Ph.D.
Collaborators
NCT06273293
NCT05599061
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06535568