NCT05529459

Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD

ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,400 (estimated)
• Sponsor: Seung-Whan Lee, M.D., Ph.D. · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Coronary Disease

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Coronary Intervention	Percutaneous Coronary Intervention

Timeline

• Start date: 2023-03-13
• Primary completion: 2026-12-31
• Completion: 2030-07-31
• First posted: 2022-09-07
• Last updated: 2025-01-10

Locations

17 sites across 1 country: South Korea