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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Hallym University Sacred Heart Hospital
NOT_YET_RECRUITING
Anyang
Bucheon Sejong Hospital
NOT_YET_RECRUITING
Bucheon-si
Inje University Busan Paik Hospital
RECRUITING
Busan
Gyeongsang National University Changwon Hospital
RECRUITING
Changwon
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Daegu Veterans Hospital
RECRUITING
Daegu
Keimyung University Dongsan Medical Center
RECRUITING
Daegu
Gangneung Asan Hospital
RECRUITING
Gangneung
Wonkwang University Hospital
RECRUITING
Iksan
Kwangju Christian Hospital
RECRUITING
Kwangju
Inje University Pusan Paik Hospital
RECRUITING
Pusan
Bundang CHA Hospital
NOT_YET_RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Veterans Hospital Service Medical Center
RECRUITING
Seoul
The Catholic University of Korea, ST. Vincent's Hospital
NOT_YET_RECRUITING
Suwon
Pusan National University Yangsan Hospital
NOT_YET_RECRUITING
Yangsan
Contact Information
Primary
Jiwon Baek, RN
cvcrc22@amc.seoul.kr
82230107267
Backup
Seung-Whan Lee, Investigator
seungwlee@amc.seoul.kr
82230103170
Time Frame
Start Date: 2023-03-13
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 2400
Treatments
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
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†
Sponsors
Collaborators: Biotronik Korea Co., Ltd
Leads: Seung-Whan Lee, M.D., Ph.D.

This content was sourced from clinicaltrials.gov

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