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

Not Applicable

Recruiting

• Conditions: Coronary Disease

• Registration Number: NCT05529459
• Lead Sponsor: Seung-Whan Lee, M.D., Ph.D.

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 ≥ 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

Study Timeline

• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2023-03-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-12-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants with unplanned repeat revascularization	12month	Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA.
Number of Participants with death	12month	Major adverse cardiac events are defined as all-cause death
Number of Participants with MI	12month	Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with bleeding	5years	Major or minor bleeding according to definitions from TIMI
Number of Participants with unplanned repeat revascularization	5years	Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA.
Number of Participants with death	5years	Major adverse cardiac events are defined as all-cause death
Number of Participants with MI	5years	Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.
Self-rated health on a vertical visual analogue scale by EQ5D	5years	EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group and provides a simple and general questionnaire for use in clinical assessments
Number of Participants with rehospitalization	5years	Rehospitalization for an acute coronary syndrome or repeat PCI
cost-effectiveness	5years	Procedure-related cost during index procedure

Trial Locations

Locations (17)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Bucheon Sejong Hospital; 🇰🇷 Bucheon, Korea, Republic of

Gyeongsang National University Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Cheongju, Korea, Republic of

Daegu Veterans Hospital; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Gangneung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Wonkwang University Hospital; 🇰🇷 Iksan, Korea, Republic of

Kwangju Christian Hospital; 🇰🇷 Kwangju, Korea, Republic of

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