Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05529459
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2022-09-02
Brief Title:
Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD
Sponsor:
Seung-Whan Lee MD PhD
Organization:
Asan Medical Center
Study Overview
Official Title:
ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSIST
Brief 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 225 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 080 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None