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

Last updated: January 9, 2025
Sponsor: Seung-Whan Lee, M.D., Ph.D.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Percutaneous Coronary Intervention

Clinical Study ID

NCT05529459
2022-1298
  • Ages > 19
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women between the ages of 19and older

  • Typical chest pain or objective evidence of myocardial ischemia suitable for PCISignificant lesions with a diameter stenosis of 50-90% in major epicardial coronaryarteries ≥ 2.25 mm in diameter by visual estimation.

  • The patient or guardian agrees to the study protocol and the schedule of clinicalfollow-up, and provides informed, written consent, as approved by the appropriateInstitutional Review Board/Ethical Committee of the respective clinical site.

Exclusion

Exclusion Criteria:

  • Coronary lesions resulting in the expected inability to perform FFR (ex, severetortuosity 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 ADPantagonist is planned within 12 months after the procedure

  • A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) inthe 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 orticagrelor)

  • Hypersensitivity or contraindication to DES material and its degradants and cobalt,chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot beadequately pre-medicated

  • Any clinically significant abnormality identified at the screening visit, physicalexamination, laboratory tests, or electrocardiogram which, in the judgment of theinvestigator, would preclude safe completion of the study

  • Unwillingness or inability to comply with the procedures described in this protocol

Study Design

Total Participants: 2400
Treatment Group(s): 1
Primary Treatment: Percutaneous Coronary Intervention
Phase:
Study Start date:
March 13, 2023
Estimated Completion Date:
July 31, 2030

Study 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

Connect with a study center

  • Hallym University Sacred Heart Hospital

    Anyang,
    Korea, Republic of

    Site Not Available

  • Bucheon Sejong Hospital

    Bucheon,
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon,
    Korea, Republic of

    Site Not Available

  • Inje University Busan Paik Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Inje university Haeundae Paik Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Gyeongsang National University Changwon Hospital

    Changwon,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju,
    Korea, Republic of

    Active - Recruiting

  • Gangwon National University Hospital

    Chuncheon,
    Korea, Republic of

    Site Not Available

  • Hankook General Hospotal

    Chungju,
    Korea, Republic of

    Site Not Available

  • Daegu Catholic University Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Daegu Veterans Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chungnam National University Sejong Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Gangneung Asan Hospital

    Gangneung,
    Korea, Republic of

    Active - Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong,
    Korea, Republic of

    Site Not Available

  • Wonkwang University Hospital

    Iksan,
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon,
    Korea, Republic of

    Site Not Available

  • ChonBuk National University Hospital

    Jeonju,
    Korea, Republic of

    Site Not Available

  • Gyeongsang National University Hospital

    Jinju,
    Korea, Republic of

    Site Not Available

  • Kwangju Christian Hospital

    Kwangju,
    Korea, Republic of

    Active - Recruiting

  • Dong-A Medical Center

    Pusan,
    Korea, Republic of

    Site Not Available

  • Inje University Pusan Paik Hospital

    Pusan,
    Korea, Republic of

    Active - Recruiting

  • Kosin University Gospel Hospital

    Pusan,
    Korea, Republic of

    Site Not Available

  • Bundang CHA Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Veterans Hospital Service Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • St.Carollo Hospital

    Suncheon,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

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

    Suwon,
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan,
    Korea, Republic of

    Site Not Available

  • Wonju Severance Christian Hospital

    Wonju,
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Yangsan,
    Korea, Republic of

    Site Not Available

  • Yeosu Jeil Hospital

    Yeosu,
    Korea, Republic of

    Site Not Available

  • Yongin Severance Hospital

    Yongin,
    Korea, Republic of

    Site Not Available

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