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

RECRUITINGN/ASponsored by Seung-Whan Lee, M.D., Ph.D.
Actively Recruiting
PhaseN/A
SponsorSeung-Whan Lee, M.D., Ph.D.
Started2023-03-13
Est. completion2026-12-31
Eligibility
Age19 Years+
Healthy vol.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

Eligibility

Age: 19 Years+Healthy volunteers accepted
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

Conditions2

Coronary DiseaseHeart Disease

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