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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.
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

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hallym University Sacred Heart Hospital
Coordinator of this site? Confirm its status
AnyangSouth KoreaNot yet recruiting
Bucheon Sejong Hospital
Coordinator of this site? Confirm its status
Bucheon-siSouth KoreaNot yet recruiting
Inje University Busan Paik Hospital
Coordinator of this site? Confirm its status
BusanSouth KoreaRecruiting
Gyeongsang National University Changwon hospital
Coordinator of this site? Confirm its status
ChangwonSouth KoreaRecruiting
Chungbuk National University Hospital
Coordinator of this site? Confirm its status
Cheongju-siSouth KoreaRecruiting
Keimyung University - Dongsan Medical Center
Coordinator of this site? Confirm its status
DaeguSouth KoreaRecruiting
Daegu Veterans Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaRecruiting
Gangneung Asan Hospital
Coordinator of this site? Confirm its status
GangneungSouth KoreaRecruiting
Wonkwang University Hospital
Coordinator of this site? Confirm its status
IksanSouth KoreaRecruiting
Kwangju Christian Hospital
Coordinator of this site? Confirm its status
KwangjuSouth KoreaRecruiting
Inje University Pusan Paik Hospital
Coordinator of this site? Confirm its status
PusanSouth KoreaRecruiting
Bundang CHA Hospital
Coordinator of this site? Confirm its status
SeongnamSouth KoreaNot yet recruiting
Veterans Hospital Service Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Korea University Anam Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
The Catholic University of Korea St. Vincent's Hospital
Coordinator of this site? Confirm its status
SuwonSouth KoreaNot yet recruiting
Pusan National University Yangsan Hospital
Coordinator of this site? Confirm its status
YangsanSouth KoreaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.