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

Primary Purpose

Coronary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Sponsored by
Seung-Whan Lee, M.D., Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym University Sacred Heart Hospital
  • Bucheon Sejong Hospital
  • Inje university Haeundae Paik Hospital
  • Gyeongsang National University Changwon Hospital
  • Chungbuk National University Hospital
  • Gangwon National University Hospital
  • Hankook General Hospotal
  • Daegu Veterans Hospital
  • Keimyung University Dongsan Medical Center
  • Gangneung Asan Hospital
  • Chung-Ang University Gwangmyeong Hospital
  • Wonkwang University Hospital
  • Inha University Hospital
  • Kwangju Christian Hospital
  • Dong-A Medical Center
  • Inje University Pusan Paik Hospital
  • Kosin University Gospel Hospital
  • Bundang CHA Hospital
  • Asan Medical CenterRecruiting
  • Kangbuk Samsung Medical Center
  • Korea University Anam Hospital
  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
  • Veterans Hospital Service Medical Center
  • St.Carollo Hospital
  • Ajou University Hospital
  • The Catholic University of Korea, ST. Vincent's Hospital
  • Ulsan University Hospital
  • Pusan National University Yangsan Hospital
  • Yeosu Jeil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

quantitative coronary angiography-guided percutaneous coronary intervention

fractional flow reserve-guided PCI

Arm Description

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

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†

Outcomes

Primary Outcome Measures

Number of Participants with death
Major adverse cardiac events are defined as all-cause death
Number of Participants with MI
Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2022
Last Updated
September 1, 2023
Sponsor
Seung-Whan Lee, M.D., Ph.D.
Collaborators
Biotronik Korea Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05529459
Brief Title
Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD
Acronym
ASSIST
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
July 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Whan Lee, M.D., Ph.D.
Collaborators
Biotronik Korea Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
quantitative coronary angiography-guided percutaneous coronary intervention
Arm Type
Experimental
Arm Description
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
Arm Title
fractional flow reserve-guided PCI
Arm Type
Active Comparator
Arm Description
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†
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
Percutaneous Coronary Intervention
Primary Outcome Measure Information:
Title
Number of Participants with death
Description
Major adverse cardiac events are defined as all-cause death
Time Frame
12month
Title
Number of Participants with MI
Description
Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.
Time Frame
12month
Title
Number of Participants with unplanned repeat revascularization
Description
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.
Time Frame
12month
Secondary Outcome Measure Information:
Title
Number of Participants with death
Description
Major adverse cardiac events are defined as all-cause death
Time Frame
5years
Title
Number of Participants with MI
Description
Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.
Time Frame
5years
Title
Number of Participants with unplanned repeat revascularization
Description
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.
Time Frame
5years
Title
Number of Participants with bleeding
Description
Major or minor bleeding according to definitions from TIMI
Time Frame
5years
Title
Number of Participants with rehospitalization
Description
Rehospitalization for an acute coronary syndrome or repeat PCI
Time Frame
5years
Title
Self-rated health on a vertical visual analogue scale by EQ5D
Description
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
Time Frame
5years
Title
cost-effectiveness
Description
Procedure-related cost during index procedure
Time Frame
5years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiwon Baek, RN
Phone
82230107267
Email
cvcrc22@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Whan Lee, Investigator
Phone
82230103170
Email
seungwlee@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Whan Lee, Investigator
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon Seok Koh, MD
First Name & Middle Initial & Last Name & Degree
Yoon Seok Koh, MD
Facility Name
Bucheon Sejong Hospital
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ha-Wook Park, MD
First Name & Middle Initial & Last Name & Degree
Ha-Wook Park, MD
Facility Name
Inje university Haeundae Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Gyeongsang National University Changwon Hospital
City
Changwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Seok Bae, MD
Email
baefach@naver.com
First Name & Middle Initial & Last Name & Degree
Jae Seok Bae, MD
Facility Name
Chungbuk National University Hospital
City
Cheongju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Min Kim, MD
First Name & Middle Initial & Last Name & Degree
Sang Min Kim, MD
Facility Name
Gangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bong-Ki Lee, MD
Email
mdbklee@kangwon.ac.kr
First Name & Middle Initial & Last Name & Degree
Bong-Ki Lee, MD
Facility Name
Hankook General Hospotal
City
Chungju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoo-Hong Lee, MD
First Name & Middle Initial & Last Name & Degree
Yoo-Hong Lee, MD
Facility Name
Daegu Veterans Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Hwan Cho, MD
First Name & Middle Initial & Last Name & Degree
Jeong Hwan Cho, MD
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuck Jun Yoon, MD
First Name & Middle Initial & Last Name & Degree
Hyuck Jun Yoon, MD
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanbit Park, MD
First Name & Middle Initial & Last Name & Degree
Hanbit Park, MD
Facility Name
Chung-Ang University Gwangmyeong Hospital
City
Gwangmyeong
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yeub Lee, MD
First Name & Middle Initial & Last Name & Degree
Sang Yeub Lee, MD
Facility Name
Wonkwang University Hospital
City
Iksan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Young Cho, MD
First Name & Middle Initial & Last Name & Degree
Jae Young Cho, MD
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Kwangju Christian Hospital
City
Kwangju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Uk Lee, MD
First Name & Middle Initial & Last Name & Degree
Seung Uk Lee, MD
Facility Name
Dong-A Medical Center
City
Pusan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Rak Cho, MD
Email
nephrone@dau.ac.kr
First Name & Middle Initial & Last Name & Degree
Yong-Rak Cho, MD
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Hyun Yang, MD
Email
yangthmd@naver.com
First Name & Middle Initial & Last Name & Degree
Tae Hyun Yang, MD
Facility Name
Kosin University Gospel Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Ho Heo, MD
First Name & Middle Initial & Last Name & Degree
Jung Ho Heo, MD
Facility Name
Bundang CHA Hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se Hun Kang, MD
First Name & Middle Initial & Last Name & Degree
Se Hun Kang, MD
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Whan Lee, MD
Email
seungwlee@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Seung-Whan Lee, MD
First Name & Middle Initial & Last Name & Degree
Pil Hyung Lee, MD
First Name & Middle Initial & Last Name & Degree
Tae Oh Kim, MD
Facility Name
Kangbuk Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Young Lee, MD
Email
jyleeheart@naver.com
First Name & Middle Initial & Last Name & Degree
Jong-Young Lee, MD
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soon Jun Hong, MD
First Name & Middle Initial & Last Name & Degree
Soon Jun Hong, MD
Facility Name
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junghoon Lee, MD
First Name & Middle Initial & Last Name & Degree
Junghoon Lee, MD
Facility Name
Veterans Hospital Service Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Lee, MD
Email
changhoon.lee121@gmail.com
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Lee, MD
Facility Name
St.Carollo Hospital
City
Suncheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang Hyun Cho, MD
First Name & Middle Initial & Last Name & Degree
Jang Hyun Cho, MD
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myeong-Ho Yoon, MD
First Name & Middle Initial & Last Name & Degree
Myeong-Ho Yoon, MD
Facility Name
The Catholic University of Korea, ST. Vincent's Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Ho Her, MD
First Name & Middle Initial & Last Name & Degree
Sung-Ho Her, MD
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Ku Chon, MD
First Name & Middle Initial & Last Name & Degree
Min Ku Chon, MD
Facility Name
Yeosu Jeil Hospital
City
Yeosu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Seok Lee, MD
First Name & Middle Initial & Last Name & Degree
Woo Seok Lee, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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