Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD

Coronary Disease Clinical Trial

— ASSIST  

Official title:

ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05529459
• Other study ID #: AMCCV2022
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: July 31, 2030

Study information

• Verified date: September 2023
• Source: Asan Medical Center
• Contact: Jiwon Baek, RN
• Phone: 82230107267
• Email: cvcrc22[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: July 31, 2030
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Procedure:
• Percutaneous Coronary Intervention
Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Bucheon Sejong Hospital	Bucheon
Korea, Republic of	Inje university Haeundae Paik Hospital	Busan
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Gangwon National University Hospital	Chuncheon
Korea, Republic of	Hankook General Hospotal	Chungju
Korea, Republic of	Daegu Veterans Hospital	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chung-Ang University Gwangmyeong Hospital	Gwangmyeong
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Kwangju Christian Hospital	Kwangju
Korea, Republic of	Dong-A Medical Center	Pusan
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Kosin University Gospel Hospital	Pusan
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	The Catholic Univ. of Korea Eunpyeong St. Mary's hospital	Seoul
Korea, Republic of	Veterans Hospital Service Medical Center	Seoul
Korea, Republic of	St.Carollo Hospital	Suncheon
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan
Korea, Republic of	Yeosu Jeil Hospital	Yeosu

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Whan Lee, M.D., Ph.D.	Biotronik Korea Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with death	Major adverse cardiac events are defined as all-cause death	12month
Primary	Number of Participants with MI	Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.	12month
Primary	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	Number of Participants with death	Major adverse cardiac events are defined as all-cause death	5years
Secondary	Number of Participants with MI	Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.	5years
Secondary	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.	5years
Secondary	Number of Participants with bleeding	Major or minor bleeding according to definitions from TIMI	5years
Secondary	Number of Participants with rehospitalization	Rehospitalization for an acute coronary syndrome or repeat PCI	5years
Secondary	Self-rated health on a vertical visual analogue scale by EQ5D	EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group and provides a simple and general questionnaire for use in clinical assessments	5years
Secondary	cost-effectiveness	Procedure-related cost during index procedure	5years