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CompletedNCT05388357FLASHUpdated Oct 24, 2024

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

An interventional study of Intervention Procedure: PCI in Coronary Vessels and Procedure PCI, sponsored by Asan Medical Center. Completed at 13 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-10-24.

Sponsored by Asan Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Coronary Vessels
  • Procedure PCI

Keywords

  • OCT, AI ,PCI
03

In context

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherIntervention Procedure: PCI

    Percutaneous Coronary Intervention

06

What researchers measure

Primary outcomes

  1. Minimal Stent Area evaluated by OCT

    Minimal Stent Area evaluated by OCT after stenting of the target lesion

    Time frame: 1hour

  2. Procedural complications

    Procedural complications including angiographic dissection, perforation, or acute closure requiring active intervention after stent implantation

    Time frame: 24hours

Secondary outcomes

  1. Procedural success

    Stent expansion (≥ 90%) in final OCT assessment and successful stent delivery without target-lesion failure in 24 hours

    Time frame: 24hours

  2. OCT endpoint

    Stent expansion, stent malapposition, intra-stent tissue (plaque or thrombus) protrusion, untreated reference segment disease

    Time frame: 24hours

  3. Angiographic endpoint

    Minimal lumen diameter at the stented segment, diameter stenosis at the stented segment, acute gain at the stented segment

    Time frame: 24hours

  4. Death

    All-cause death , Cardiac and non-Cardiac death

    Time frame: 6month

  5. MI

    Any MI( periprocedural/spontaneous MI), Target vessel-MI and non-target vessel-MI

    Time frame: 6month

  6. Stent thrombosis

    definite/probable

    Time frame: 6month

  7. Revascularization

    Any revascularization,Target vessel and target lesion revascularization

    Time frame: 6month

  8. Composite of event

    Composite of all-cause death, myocardial infarction, stent thrombosis, or revascularization

    Time frame: 6month

  9. 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.

    Time frame: 6month

  10. 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.

    Time frame: 6month

  11. Cost-effective analysis

    Cost-effective analysis based on average treatment costs for two treatment

    Time frame: 6month

07

Study locations

13 sites
  • 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, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05388357
Lead sponsor
Asan Medical Center
Collaborators
Korea Medical Device Development Fund, Medipixel,Inc
Responsible party
Jung-min Ahn (Professor, Asan Medical Center) — Principal investigator
First posted
May 24, 2022
Start date
Oct 4, 2022
Primary completion
Jun 30, 2024
Completion
Oct 2, 2024
Last update
Oct 24, 2024

Study contacts

Jung- min Ahn
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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