Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD
ASSIST
ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease
1 other identifier
interventional
2,400
1 country
17
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedStudy Start
First participant enrolled
March 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
January 10, 2025
January 1, 2025
3.8 years
September 2, 2022
January 9, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants with death
Major adverse cardiac events are defined as all-cause death
12month
Number of Participants with MI
Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.
12month
Number of Participants with unplanned repeat revascularization
Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA.
12month
Secondary Outcomes (7)
Number of Participants with death
5years
Number of Participants with MI
5years
Number of Participants with unplanned repeat revascularization
5years
Number of Participants with bleeding
5years
Number of Participants with rehospitalization
5years
- +2 more secondary outcomes
Study Arms (2)
quantitative coronary angiography-guided percutaneous coronary intervention
EXPERIMENTALSuccessful revascularization of all coronary artery lesions or segments ≥2.25 mm\* in diameter with ≥50% diameter stenosis by QCA regardless of their functional significance
fractional flow reserve-guided PCI
ACTIVE COMPARATORSuccessful revascularization of all coronary artery lesions or segments ≥2.25 mm in diameter with evidence of ischemia or hemodynamic significance by FFR ≤ 0.80 regardless of their anatomic severityâ€
Interventions
Percutaneous Coronary Intervention
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Whan Lee, M.D., Ph.D.lead
- Biotronik Korea Co., Ltdcollaborator
Study Sites (17)
Hallym University Sacred Heart Hospital
Anyang, South Korea
Bucheon Sejong Hospital
Bucheon-si, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Daegu Veterans Hospital
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Wonkwang University Hospital
Iksan, South Korea
Kwangju Christian Hospital
Kwangju, South Korea
Inje University Pusan Paik Hospital
Pusan, South Korea
Bundang CHA Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Veterans Hospital Service Medical Center
Seoul, South Korea
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Whan Lee, Investigator
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 2, 2022
First Posted
September 7, 2022
Study Start
March 13, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
July 31, 2030
Last Updated
January 10, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share