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

Fully Automated Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation (FLASH): Multicenter, Randomized Controlled Non-Interiority Trial

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: Completed
• Conditions: Coronary Vessels; Procedure PCI
• Intervention / Treatment: Other: Intervention Procedure: PCI

Detailed Description

1. AI-QCA-assisted DES implantation

   After coronary angiography, AI-QCA software will be used to determine the lesion length and the reference vessel diameter in real time to determine the appropriate stent size for implantation. The procedure is performed as follows:

   1. Select the optimal projection angle providing the best view of the lesion.
   2. Provide sufficient nitroglycerin for vasodilation. If the lesion is severely stenotic, perform balloon angioplasty, followed by nitroglycerin supply.
   3. Perform AI-QCA to measure the length of the lesion and the inside diameter of the proximal and distal reference vessels.
   4. Determine the stent length and size according to the AI-QCA measurements. Select a stent that is 20% larger than the distal reference vessel diameter and that can provide coverage for both the proximal and distal reference vessels.
   5. Perform high-pressure balloon dilation after stent implantation, with the final balloon size being 20% larger than the distal and proximal reference vessel diameters.
   6. Perform a final coronary angiogram if no procedural complications are observed on the angiogram and stent expansion is confirmed.
   7. Perform a final OCT to measure the stent area (mm2), the primary efficacy endpoint.
   8. If significant suboptimal stent results, such as severe underexpansion, extensive strut malapposition, or major stent edge dissection, occur, additional procedures to correct them are permitted to ensure patient safety, although they are generally discouraged. (The primary endpoint will be assessed by OCT run before such correction.)
2. OCT guided DES implantation

After coronary angiography, OCT is performed to determine the appropriate stent size for implantation. After the stent procedure, OCT is performed again to check for an area that is smaller than the area of distal reference vessel and for sufficient dilatation. If necessary, high-pressure balloon dilation is performed to minimize residual stenosis. The procedure is performed as follows:

1. Select the optimal projection angle providing the best view of the lesion.
2. Provide sufficient nitroglycerin for vasodilation. If the lesion is severely stenotic, perform balloon angioplasty, followed by nitroglycerin supply.
3. Perform OCT to obtain pre-procedural images of the vessel. If there is a stenosis and OCT images cannot be obtained, perform OCT after adequate balloon angioplasty.
4. Determine the length and size of the stent to be implanted according to the OCT images. Select the stent size in consideration of the mean lumen diameter and mean external elastic lamina (EEL) diameter of the distal reference vessel. If the EEL is not observed, use a stent that is 0.25 mm larger than the mean lumen diameter. Select the length by measuring the length of the proximal and distal reference vessel segments on the OCT.
5. Perform high-pressure balloon dilation after stent implantation. Select the final balloon size by considering the inside diameters of the distal and proximal reference vessels and EEL diameter.
6. Perform OCT. If no procedure-related complications are observed and there is no underexpansion or malapposition of the stent, perform a final coronary angiogram. If procedure-related complications or underexpansion or malapposition of the stent is observed, correct it, and then perform a final OCT to measure the stent area (mm2), the primary efficacy endpoint.

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

Contacts and Locations

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 evaluated by OCT	Minimal Stent Area evaluated by OCT after stenting of the target lesion	1hour
Procedural complications	Procedural complications including angiographic dissection, perforation, or acute closure requiring active intervention after stent implantation	24hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Stent expansion (≥ 90%) in final OCT assessment and successful stent delivery without target-lesion failure in 24 hours	24hours
OCT endpoint	Stent expansion, stent malapposition, intra-stent tissue (plaque or thrombus) protrusion, untreated reference segment disease	24hours
Angiographic endpoint	Minimal lumen diameter at the stented segment, diameter stenosis at the stented segment, acute gain at the stented segment	24hours
Death	All-cause death , Cardiac and non-Cardiac death	6month
MI	Any MI( periprocedural/spontaneous MI), Target vessel-MI and non-target vessel-MI	6month
Stent thrombosis	definite/probable	6month
Revascularization	Any revascularization,Target vessel and target lesion revascularization	6month
Cost-effective analysis	Cost-effective analysis based on average treatment costs for two treatment	6month
Composite of event	Composite of all-cause death, myocardial infarction, stent thrombosis, or revascularization	6month
Quality of life score assessed by the EQ-5D	The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively.	6month
Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)	HINT-8 was developed based on 4 health dimensions: physical, mental, social, and positive health dimensions. It consists of climbing stairs, endurance to pain, vitality, working, depression, memory, sleep, and happiness.	6month

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 (Actual): June 30, 2024
• Study Completion (Actual): October 2, 2024

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): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 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