AI Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation (FLASH)

A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Trial : AI-QCA Guided PCI Versus Optical Coherence Tomography Guided PCI

This study is to establish the primary hypothesis thatAI -QCA guided PCI is non-inferior to Optical coherence tomography-guided Percutaneous coronary intervention regarding minimal Stent area by Final OCT and Procedural MACE

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Vessels; Procedure PCI
• Intervention / Treatment: Other: Intervention Procedure: PCI

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung hwa Lee, RN; Phone Number: 821028879726; Email: nurse9726@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Sejong General Hospital
  • Chungbuk, Korea, Republic of
    • Chungbuk National University Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Gangneung, Korea, Republic of
    • Gangneung Asan Hospital
  • Gyeonggi-do, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Gyeonggi-do, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, Korea, Republic of
    • Yougin Severance Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Medical Center
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

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 at least 19 years of age
• Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
• Subject with severe coronary artery disease undergoing PCI
• Written informed consent

Exclusion Criteria:

• Angiographic exclusion criteria 1) Left main lesion 2) Chronic total occlusion 3)Graft vascular lesion 4) Requiring two-stent techniques for coronary bifurcation lesions 5)Any lesion characteristics resulting in the expected inability to deliver OCT catheter to the lesion ( eg,tortuosity, moderate or severe vessel calcification)
• Acute or chronic renal dysfunction (Plasma creatinine 2.0mg/dL or more) except patients undergoing dialysis
• Primary coronary angioplasty in ST-elevation myocardial infarction(within 12-24 hours of symptom onset)
• Previous PCI with BVS
• LV dysfunction (LVEF) < 30%
• Hypersensitivity to DES and its components or there is a reason for prohibition (everolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers)
• Patients who require surgery requiring discontinuation of antiplatelet drugs within 1 year of the procedure
• Life expectancy < 1 year for any disease
• Pregnancy or breast-feeding
• Patients unsuitable for enrollment judged by the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI -guided PCI; based on AI-QCA measurement, a drug eluting stent of an appropriate size is inserted and then high-pressure balloon dilatation is additionally actively performed in all patients.	Other: Intervention Procedure: PCI; Percutaneous Coronary Intervention
Active Comparator: OCT-guided PCI; In the OCT group, the size of the stent is determined using intravascular optical coherence tomography, and balloon dilatation is additionally performed if necessary.	Other: Intervention Procedure: PCI; Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal Stent Area by Final OCT	Minimal Stent Area evaluated by OCT after stenting of the target lesion	1hour
Procedural MACE	Procedural MACE was defined as procedural complication ( angio graphic dissection , perforation, thrombus, or acute closure requiring active intervention	24hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	stent expansion is 90% or more by OCT and no failure of the target lesion occurred within 24 hours after the procedure.	24hours
Death	cardiac, vascular, non-cardiovascular death	1year
MI	periprocedural/spontaneous MI	1year
Stent thrombosis	definite/probable	1year
Revascularization	Revascularization	1year
OCT endpoint	stent expansion,stent malaposition,tissue or thrombus protrusion,untreated reference segment disease	24hours
Angiographic endpoint	stent minimum diameter (minimal lumen diameter),stenosis (percent diameter stenosis)acute luminal gain,maximum stent or reference vessel diameter,aortic dissection	24hours

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Korea Medical Device Development Fund; Medipixel,Inc
• Investigators: Principal Investigator: Jung- min Ahn, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: OCT, AI ,PCI
• Other Study ID Numbers: AMCCV2022-02

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