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

Coronary Vessels Clinical Trial

— FLASH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05388357
• Other study ID #: AMCCV2022-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Vessels

Intervention

Other:
• Intervention Procedure: PCI
Percutaneous Coronary Intervention

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Asan Medical Center	Korea Medical Device Development Fund, Medipixel,Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal Stent Area by Final OCT	Minimal Stent Area evaluated by OCT after stenting of the target lesion	1hour
Primary	Procedural MACE	Procedural MACE was defined as procedural complication ( angio graphic dissection , perforation, thrombus, or acute closure requiring active intervention	24hours
Secondary	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
Secondary	OCT endpoint	stent expansion,stent malaposition,tissue or thrombus protrusion,untreated reference segment disease	24hours
Secondary	Angiographic endpoint	stent minimum diameter (minimal lumen diameter),stenosis (percent diameter stenosis)acute luminal gain,maximum stent or reference vessel diameter,aortic dissection	24hours
Secondary	Death	cardiac, vascular, non-cardiovascular death	1year
Secondary	MI	periprocedural/spontaneous MI	1year
Secondary	Stent thrombosis	definite/probable	1year
Secondary	Revascularization	Revascularization	1year