Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD
ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease
Seung-Whan Lee, M.D., Ph.D.
2,400 participants
Mar 13, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria15
- 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
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Interventions
Percutaneous Coronary Intervention
Locations(17)
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NCT05529459