Clinical trial NCT05388357: AI Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation
Official title: Fully Automated Quantitative Coronary Angiography Versus Optical Coherent Tomography Guidance for Coronary Stent Implantation (FLASH): Multicenter, Randomized Controlled Non-Interiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Vessels
Procedure PCI
Keywords: OCT, AI ,PCI
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Medical Device Development Fund
name: Medipixel,Inc
First posted: 2022-05-24
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Minimal Stent Area evaluated by OCT
timeFrame: 1hour
measure: Procedural complications
timeFrame: 24hours
Secondary outcomes:
measure: Procedural success
timeFrame: 24hours
measure: OCT endpoint
timeFrame: 24hours
measure: Angiographic endpoint
timeFrame: 24hours
measure: Death
timeFrame: 6month
measure: MI
timeFrame: 6month
measure: Stent thrombosis
timeFrame: 6month
measure: Revascularization
timeFrame: 6month
measure: Composite of event
timeFrame: 6month
measure: Quality of life score assessed by the EQ-5D
timeFrame: 6month
measure: Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)
timeFrame: 6month
measure: Cost-effective analysis
timeFrame: 6month
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Gyeonggi-do
country: Korea, Republic of
facility: Yougin Severance Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Jung- min Ahn
role: PRINCIPAL_INVESTIGATOR
References: