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

Not Applicable

Completed

• Conditions: Coronary Vessels; Procedure PCI

• Registration Number: NCT05388357
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-24
• Study Start: 2022-10-04
• Primary Completion: 2024-06-30
• Status Verified: 2024-10
• Study Completion: 2024-10-02
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Procedural success	24hours	Stent expansion (≥ 90%) in final OCT assessment and successful stent delivery without target-lesion failure in 24 hours
OCT endpoint	24hours	Stent expansion, stent malapposition, intra-stent tissue (plaque or thrombus) protrusion, untreated reference segment disease
Angiographic endpoint	24hours	Minimal lumen diameter at the stented segment, diameter stenosis at the stented segment, acute gain at the stented segment
Death	6month	All-cause death , Cardiac and non-Cardiac death
MI	6month	Any MI( periprocedural/spontaneous MI), Target vessel-MI and non-target vessel-MI
Stent thrombosis	6month	definite/probable
Revascularization	6month	Any revascularization,Target vessel and target lesion revascularization
Composite of event	6month	Composite of all-cause death, myocardial infarction, stent thrombosis, or revascularization
Quality of life score assessed by the EQ-5D	6month	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.
Quality of life score assessed by Health-related Quality of Life Instrument with 8 Items (HINT-8)	6month	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.
Cost-effective analysis	6month	Cost-effective analysis based on average treatment costs for two treatment

Trial Locations

Locations (13)

Seoul National University Bundang hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Sejong General Hospital; 🇰🇷 Bucheon, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Chungbuk, Korea, Republic of

GangNeung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Yougin Severance Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Gyeonggi-do, Korea, Republic of

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of