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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Disease
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention

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

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seung-whan Lee, Investigator; Phone Number: 82230103170; Email: seungwlee@amc.seoul.kr
• Study Contact Backup: Name: Jiwon Baek, RN; Phone Number: 82230107267; Email: cvcrc22@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Not yet recruiting
    • Hallym University Sacred Heart Hospital
    • Contact: Yoon Seok Koh, MD
    • Principal Investigator: Yoon Seok Koh, MD
  • Bucheon, Korea, Republic of
    • Not yet recruiting
    • Bucheon Sejong Hospital
    • Principal Investigator: Ha-Wook Park, MD
    • Contact: Ha-Wook Park, MD
  • Busan, Korea, Republic of
    • Not yet recruiting
    • Inje University Haeundae Paik Hospital
  • Changwon, Korea, Republic of
    • Not yet recruiting
    • Gyeongsang National University Changwon Hospital
    • Principal Investigator: Jae Seok Bae, MD
    • Contact: Jae Seok Bae, MD; Email: baefach@naver.com
  • Cheongju, Korea, Republic of
    • Not yet recruiting
    • Chungbuk National University Hospital
    • Contact: Sang Min Kim, MD
    • Principal Investigator: Sang Min Kim, MD
  • Chuncheon, Korea, Republic of
    • Not yet recruiting
    • Gangwon National University Hospital
    • Principal Investigator: Bong-Ki Lee, MD
    • Contact: Bong-Ki Lee, MD; Email: mdbklee@kangwon.ac.kr
  • Chungju, Korea, Republic of
    • Not yet recruiting
    • Hankook General Hospotal
    • Contact: Yoo-Hong Lee, MD
    • Principal Investigator: Yoo-Hong Lee, MD
  • Daegu, Korea, Republic of
    • Not yet recruiting
    • Keimyung University Dongsan Medical Center
    • Principal Investigator: Hyuck Jun Yoon, MD
    • Contact: Hyuck Jun Yoon, MD
  • Daegu, Korea, Republic of
    • Not yet recruiting
    • Daegu Veterans Hospital
    • Contact: Jeong Hwan Cho, MD
    • Principal Investigator: Jeong Hwan Cho, MD
  • Gangneung, Korea, Republic of
    • Not yet recruiting
    • Gangneung Asan Hospital
    • Contact: Hanbit Park, MD
    • Principal Investigator: Hanbit Park, MD
  • Gwangmyeong, Korea, Republic of
    • Not yet recruiting
    • Chung-Ang University Gwangmyeong Hospital
    • Contact: Sang Yeub Lee, MD
    • Principal Investigator: Sang Yeub Lee, MD
  • Iksan, Korea, Republic of
    • Not yet recruiting
    • Wonkwang University Hospital
    • Contact: Jae Young Cho, MD
    • Principal Investigator: Jae Young Cho, MD
  • Incheon, Korea, Republic of
    • Not yet recruiting
    • Inha University Hospital
  • Kwangju, Korea, Republic of
    • Not yet recruiting
    • Kwangju Christian Hospital
    • Contact: Seung Uk Lee, MD
    • Principal Investigator: Seung Uk Lee, MD
  • Pusan, Korea, Republic of
    • Not yet recruiting
    • Inje University Pusan Paik Hospital
    • Principal Investigator: Tae Hyun Yang, MD
    • Contact: Tae Hyun Yang, MD; Email: yangthmd@naver.com
  • Pusan, Korea, Republic of
    • Not yet recruiting
    • Dong-A Medical Center
    • Contact: Yong-Rak Cho, MD; Email: nephrone@dau.ac.kr
    • Principal Investigator: Yong-rak Cho, MD
  • Pusan, Korea, Republic of
    • Not yet recruiting
    • Kosin University Gospel Hospital
    • Principal Investigator: Jung Ho Heo, MD
    • Contact: Jung Ho Heo, MD
  • Seongnam, Korea, Republic of
    • Not yet recruiting
    • Bundang Cha Hospital
    • Contact: Se Hun Kang, MD
    • Principal Investigator: Se Hun Kang, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Seung-Whan Lee, MD; Email: seungwlee@amc.seoul.kr
    • Principal Investigator: Seung-Whan Lee, MD
    • Sub-Investigator: Tae Oh Kim, MD
    • Sub-Investigator: Pil Hyung Lee, MD
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Korea University Anam Hospital
    • Contact: Soon Jun Hong, MD
    • Principal Investigator: Soon Jun Hong, MD
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
    • Principal Investigator: Junghoon Lee, MD
    • Contact: Junghoon Lee, MD
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Veterans Hospital Service Medical Center
    • Principal Investigator: Chang-Hoon Lee, MD
    • Contact: Chang-Hoon Lee, MD; Email: changhoon.lee121@gmail.com
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Kangbuk Samsung Medical Center
    • Contact: Jong-Young Lee, MD; Email: jyleeheart@naver.com
    • Principal Investigator: Jong-young Lee, MD
  • Suncheon, Korea, Republic of
    • Not yet recruiting
    • St.Carollo Hospital
    • Contact: Jang Hyun Cho, MD
    • Principal Investigator: Jang Hyun Cho, MD
  • Suwon, Korea, Republic of
    • Not yet recruiting
    • Ajou University Hospital
    • Principal Investigator: Myeong-Ho Yoon, MD
    • Contact: Myeong-Ho Yoon, MD
  • Suwon, Korea, Republic of
    • Not yet recruiting
    • The Catholic University of Korea, St. Vincent's Hospital
    • Contact: Sung-ho Her, MD
    • Principal Investigator: Sung-ho Her, MD
  • Ulsan, Korea, Republic of
    • Not yet recruiting
    • Ulsan University Hospital
  • Yangsan, Korea, Republic of
    • Not yet recruiting
    • Pusan National University Yangsan Hospital
    • Contact: Min Ku Chon, MD
    • Principal Investigator: Min Ku Chon, MD
  • Yeosu, Korea, Republic of
    • Not yet recruiting
    • Yeosu Jeil Hospital
    • Contact: Woo Seok Lee, MD
    • Principal Investigator: Woo Seok Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: quantitative coronary angiography-guided percutaneous coronary intervention; Successful revascularization of all coronary artery lesions or segments ≥2.25 mm* in diameter with ≥50% diameter stenosis by QCA regardless of their functional significance	Procedure: Percutaneous Coronary Intervention; Percutaneous Coronary Intervention
Active Comparator: fractional flow reserve-guided PCI; Successful 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 severity†	Procedure: Percutaneous Coronary Intervention; Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with death	Major adverse cardiac events are defined as all-cause death	5years
Number of Participants with MI	Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.	5years
Number of Participants with bleeding	Major or minor bleeding according to definitions from TIMI	5years
Number of Participants with rehospitalization	Rehospitalization for an acute coronary syndrome or repeat PCI	5years
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
cost-effectiveness	Procedure-related cost during index procedure	5years
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

Collaborators and Investigators

• Sponsor: Seung-Whan Lee, M.D., Ph.D.
• Collaborators: Biotronik Korea Co., Ltd
• Investigators: Principal Investigator: Seung-Whan Lee, Investigator, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: AMCCV2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No