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

Launched by SEUNG-WHAN LEE, M.D., PH.D. · Sep 2, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating two different methods for treating patients with significant coronary artery disease (CAD) who require a procedure called percutaneous coronary intervention (PCI), where a small tube is inserted to open blocked arteries. The study compares two techniques: one that looks at the physical structure of the arteries (anatomic guidance) and another that measures how well blood is flowing through them (physiologic guidance). The goal is to find out which method leads to better health outcomes for patients after they receive drug-eluting stents (a type of implant that helps keep arteries open).

To be eligible for this trial, participants must be adults over the age of 19 who experience chest pain or have other signs of reduced blood flow to the heart. They should have specific blockages in their arteries that can be treated with PCI. However, there are some exclusions, such as having previous heart surgeries or certain severe health conditions. If you join the study, you will receive the standard care for your condition and will be closely monitored by medical professionals throughout the process. This study is currently recruiting participants, and those interested should talk to their healthcare provider about the possibility of joining.

Gender

ALL

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