Comparing two methods for heart artery treatment in patients with coronary disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the clinical outcomes of two different guidance methods for complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention with drug-eluting stents. It is a prospective, multicenter, open-label, randomized trial where patients will be assigned to either quantitative coronary angiography (QCA)-guided or fractional flow reserve (FFR)-guided strategies. Eligible patients will have significant stenotic lesions and will be monitored for outcomes based on the chosen intervention method. The study aims to determine which guidance method leads to better clinical results.

Why it matters

Who can join: the full rules

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

Where it's running

• Inje University Busan Paik Hospital
  Busan, South Korea Recruiting
• Gyeongsang National University Changwon Hospital
  Changwon, South Korea Recruiting
• Chungbuk National University Hospital
  Cheongju-si, South Korea Recruiting
• Daegu Veterans Hospital
  Daegu, South Korea Recruiting
• Keimyung University Dongsan Medical Center
  Daegu, South Korea Recruiting
• Gangneung Asan Hospital
  Gangneung, South Korea Recruiting

Study contacts

• Principal investigator: Seung-Whan Lee, Investigator — Asan Medical Center
• Study coordinator: Jiwon Baek, RN
• Email: cvcrc22@amc.seoul.kr
• Phone: 82230107267

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tailored digital support to cut sedentary time in long-term cardiac rehab

  In adults in a long-term cardiac rehabilitation program, this study tests whether a personalized behavioural program with digital tools can reduce daily sitting time.

  Recruiting University of Lisbon · Lisbon, Lisbon District · NCT07910812

• Predicting how coronary artery disease progresses in adults 45 and younger

  This project will try to build prediction models using coronary CT scans and health data from people aged 18–45 to see who is more likely to have plaque get worse over time.

  Recruiting Fu Wai Hospital, Beijing, China · Beijing · NCT07316452

• Freesolve resorbable magnesium scaffold vs. Xience stent for up to two new heart artery lesions

  This trial tests whether the Freesolve resorbable magnesium scaffold works as well as the Xience drug-eluting stent for treating up to two new coronary artery lesions in adults.

  Recruiting at 3 sites Teleflex · Washington D.C., District of Columbia and 2 other locations · NCT07258290

• Italian Cardiac Rehabilitation Registry for Coronary Disease and Heart Failure

  This registry collects real-world information to see how cardiac rehabilitation programs work for adults recovering from coronary disease or heart failure across Italy.

  Recruiting Fondazione Don Carlo Gnocchi ETS · Milan · NCT07094737

• Orbital atherectomy versus standard balloon strategy for calcified coronary bifurcation lesions

  This study tests whether using orbital atherectomy before stenting helps adults with moderately or severely calcified coronary bifurcation lesions get better stent results than the standard balloon-first approach.

  Recruiting at 9 sites Fundación EPIC · Alicante and 8 other locations · NCT06736899

• Healthy Nordic diet's effects on heart disease

  This study is testing if following a Healthy Nordic diet can help people with coronary heart disease improve their heart health over 18 months.

  Recruiting Uppsala University · Uppsala · NCT06701968

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.