Clinical trial NCT05529459: Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD
Official title: ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Biotronik Korea Co., Ltd
First posted: 2022-09-07
Enrollment: 2400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Detailed description: This is a prospective, multicenter center, open-label, randomized trial to compare QCA-guided versus FFR-guided CR strategies in patients with significant CAD who are undergoing PCI with DES. Patients with symptoms or evidence of myocardial ischemia are eligible for enrollment if there have stenotic lesions with a diameter stenosis of 50%-90% in major epicardial coronary arteries ≥ 2.25 mm in diameter by visual estimation, and CR is expected to be achievable by PCI. The detailed information for inclusion and exclusion criteria is described below in the session 4. Patients meeting inclusion criteria without any exclusion criteria will be randomized to either QCA-guided CR or FFR-guided CR group. In the QCA-guided CR group, PCI will be performed if there are lesions with diameter stenosis ≥ 50% by QCA during the index procedure (and, if necessary, planned staged procedure). In the FFR-guided CR group, FFR is measured for the target coronary lesions, and then PCI will be performed for the lesions with FFR ≤0.80. Post-PCI FFR measurement is strongly recommended. However, additional procedures are not recommended based on post-PCI FFR value because there is no consensus of the optimal cut-off value to define physiologic CR. In both QCA-guided and FFR-guided PCI groups, imaging guidance during PCI is left at the discretion of the operator. However, routine high pressure post-dilation with noncompliant balloons is recommended to achieve optimal stent expansion with minimal residual stenosis (diameter stenosis \< 10% on visual estimation). Patients will be followed clinically at 1, 6, 12 months, and then upto 5 years after the index procedure

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

Primary outcomes:
measure: Number of Participants with death
timeFrame: 12month
measure: Number of Participants with MI
timeFrame: 12month
measure: Number of Participants with unplanned repeat revascularization
timeFrame: 12month
Secondary outcomes:
measure: Number of Participants with death
timeFrame: 5years
measure: Number of Participants with MI
timeFrame: 5years
measure: Number of Participants with unplanned repeat revascularization
timeFrame: 5years
measure: Number of Participants with bleeding
timeFrame: 5years
measure: Number of Participants with rehospitalization
timeFrame: 5years
measure: Self-rated health on a vertical visual analogue scale by EQ5D
timeFrame: 5years
measure: cost-effectiveness
timeFrame: 5years
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Veterans Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Veterans Hospital Service Medical Center
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Whan Lee, Investigator
role: PRINCIPAL_INVESTIGATOR
References: