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

NCT ID: NCT05529459

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2030-07-31

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

Conditions

Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

quantitative coronary angiography-guided percutaneous coronary intervention

Successful revascularization of all coronary artery lesions or segments ≥2.25 mm\* in diameter with ≥50% diameter stenosis by QCA regardless of their functional significance

Group Type: EXPERIMENTAL

Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Percutaneous Coronary Intervention

fractional flow reserve-guided PCI

Successful revascularization of all coronary artery lesions or segments ≥2.25 mm in diameter with evidence of ischemia or hemodynamic significance by FFR ≤ 0.80 regardless of their anatomic severity†

Group Type: ACTIVE_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention

Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik Korea Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Seung-Whan Lee, M.D., Ph.D.

OTHER

Sponsor Role: lead

Responsible Party

Seung-Whan Lee, M.D., Ph.D.

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seung-Whan Lee, Investigator

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status: NOT_YET_RECRUITING

Bucheon Sejong Hospital

Bucheon-si, , South Korea

Site Status: NOT_YET_RECRUITING

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status: RECRUITING

Gyeongsang National University Changwon Hospital

Changwon, , South Korea

Site Status: RECRUITING

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status: RECRUITING

Daegu Veterans Hospital

Daegu, , South Korea

Site Status: RECRUITING

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status: RECRUITING

Gangneung Asan Hospital

Gangneung, , South Korea

Site Status: RECRUITING

Wonkwang University Hospital

Iksan, , South Korea

Site Status: RECRUITING

Kwangju Christian Hospital

Kwangju, , South Korea

Site Status: RECRUITING

Inje University Pusan Paik Hospital

Pusan, , South Korea

Site Status: RECRUITING

Bundang CHA Hospital

Seongnam, , South Korea

Site Status: NOT_YET_RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Korea University Anam Hospital

Seoul, , South Korea

Site Status: RECRUITING

Veterans Hospital Service Medical Center

Seoul, , South Korea

Site Status: RECRUITING

The Catholic University of Korea, ST. Vincent's Hospital

Suwon, , South Korea

Site Status: NOT_YET_RECRUITING

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status: NOT_YET_RECRUITING

Countries

South Korea

Central Contacts

Jiwon Baek, RN

Role: CONTACT

cvcrc22@amc.seoul.kr

82230107267

Seung-Whan Lee, Investigator

Role: CONTACT

seungwlee@amc.seoul.kr

82230103170

Facility Contacts

Kyoung-Ha Park, MD

Role: primary

Ha-Wook Park, MD

Role: primary

Tae-Hyun Yang, MD

Role: primary

Jae Seok Bae, MD

Role: primary

baefach@naver.com

Sang Min Kim, MD

Role: primary

Jeong Hwan Cho, MD

Role: primary

Hyuck Jun Yoon, MD

Role: primary

Hanbit Park, MD

Role: primary

Jae Young Cho, MD

Role: primary

Seung Uk Lee, MD

Role: primary

Tae Hyun Yang, MD

Role: primary

yangthmd@naver.com

Se Hun Kang, MD

Role: primary

Seung-Whan Lee, MD

Role: primary

seungwlee@amc.seoul.kr

Hyungjun Joo, MD

Role: primary

Chang-Hoon Lee, MD

Role: primary

changhoon.lee121@gmail.com

Sung-Ho Her, MD

Role: primary

mingu chon, MD

Role: primary

Other Identifiers

2022-1298

Identifier Type: -

Identifier Source: org_study_id