NCT05529459Recruiting
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
Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2400 (estimated)
- First submitted
- 2 Sept 2022
- Start date
- 13 Mar 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Seung-Whan Lee, M.D., Ph.D.
- Diseases
- Coronary artery disease
- NCT number
- NCT05529459
What you commit to
- Study type: Interventional
- Planned participants: 2400
- From 13 Mar 2023 to the primary completion date, 31 Dec 2026
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PCI within 6 months before the index procedure
- Previous coronary artery bypass graft surgery
- Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure
Other illness
- 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
- 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
Lab values
- Left ventricular dysfunction (ejection fraction \< 35%)
- 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
Age
- Life expectancy \< 1 years for any non-cardiac or cardiac causes
Other
- 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
- Cardiogenic shock or hemodynamic instability
- Patient's pregnant or breast-feeding or child-bearing potential.
- A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor)
- Unwillingness or inability to comply with the procedures described in this protocol
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hallym University Sacred Heart Hospital Coordinator of this site? Confirm its status | Anyang | South Korea | Not yet recruiting |
| Bucheon Sejong Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Not yet recruiting |
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Gyeongsang National University Changwon hospital Coordinator of this site? Confirm its status | Changwon | South Korea | Recruiting |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Recruiting |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Daegu Veterans Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Gangneung Asan Hospital Coordinator of this site? Confirm its status | Gangneung | South Korea | Recruiting |
| Wonkwang University Hospital Coordinator of this site? Confirm its status | Iksan | South Korea | Recruiting |
| Kwangju Christian Hospital Coordinator of this site? Confirm its status | Kwangju | South Korea | Recruiting |
| Inje University Pusan Paik Hospital Coordinator of this site? Confirm its status | Pusan | South Korea | Recruiting |
| Bundang CHA Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Not yet recruiting |
| Veterans Hospital Service Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Not yet recruiting |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.