OCT-Guided Stent Optimization for Short-Duration Dual Antiplatelet Therapy in Stable Angina
NCT ID: NCT07198529
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
130 participants
INTERVENTIONAL
2025-09-30
2029-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PCI with drug-eluting stents is a standard treatment for patients with stable angina, and these patients are usually prescribed DAPT for 6 to 12 months to prevent stent thrombosis and other complications. However, extended use of DAPT increases the risk of bleeding, which can lead to significant medical problems, especially in patients with high bleeding risk.
OCT provides detailed, high-resolution images of the coronary arteries and the implanted stents, allowing physicians to optimize stent expansion and positioning. By ensuring that the stent is well-placed and fully expanded, OCT guidance may lower the risk of complications, potentially reducing the need for prolonged DAPT.
In this prospective study, patients with stable angina who require stent implantation will be enrolled and treated with OCT-guided PCI followed by a short course of DAPT. Their outcomes will be compared with those managed using conventional strategies.
The primary goal of this trial is to determine whether OCT-guided stent optimization can safely support a short-duration DAPT strategy, thereby reducing bleeding risk without compromising protection against ischemic events such as restenosis, myocardial infarction, or stent thrombosis.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Optical coherence tomography (OCT) provides high-resolution intravascular imaging that allows precise assessment of stent apposition, expansion, and the presence of dissections. Previous studies, including Kubo et al. (2022), have proposed OCT-based criteria for stent optimization, demonstrating that inadequate stent expansion or a minimum lumen area (MLA) \< 4.5 mm² is associated with worse outcomes. However, to date, few clinical studies have directly evaluated whether OCT-guided stent optimization can support individualized adjustment of DAPT duration.
The COMFORT-SHORT study is a prospective, single-center, open-label pilot registry designed to investigate the safety and feasibility of OCT-guided stent optimization in applying short-term DAPT strategies. Patients with stable angina undergoing PCI with drug-eluting stent implantation will be enrolled. All participants will undergo OCT during PCI to evaluate stent deployment. Stent size and length will be determined based on OCT analysis, and final imaging will be reviewed to confirm whether the procedure meets predefined optimization criteria.
Patients whose stents are confirmed as optimized will be transitioned to 1 month of DAPT followed by clopidogrel monotherapy. Patients with suboptimal results (e.g., malapposition, medial dissection, under-expansion) will continue standard DAPT for 6-12 months, based on guideline recommendations and individual bleeding. Importantly, patients with non-optimized stents will not be excluded; they will be followed prospectively, and outcomes will be compared with those of optimized patients.
The primary endpoint is the incidence of net adverse clinical events (NACE) at 12 months, comparing short-term versus standard DAPT strategies according to stent optimization status. All enrolled patients will undergo scheduled follow-up at 1, 6, and 12 months after PCI.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Short DAPT
Patients with optimized stent results confirmed by OCT will receive 1 month of dual antiplatelet therapy followed by clopidogrel monotherapy.
OCT-guided PCI
All patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection).
Short DAPT
Patients receive aspirin and clopidogrel for 1 month after PCI. After 1 month, aspirin is discontinued and clopidogrel monotherapy is continued.
Standard DAPT
Patients with suboptimal stent results (malapposition, dissection, under-expansion) with high bleeding risk will continue dual antiplatelet therapy for 6 months, according to guideline recommendations.
Standard DAPT
Patients with high bleeding risk will receive aspirin and clopidogrel for 6 months after PCI (unoptimization confirmed in OCT), followed by single antiplatelet therapy thereafter.
OCT-guided PCI
All patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection).
Extended DAPT
Patients with suboptimal stent results and high ischemic risk, as judged by the operator, will remain on dual antiplatelet therapy for 12 months.
Extended DAPT
Patients (with stet unoptimazation results in OCT imaging) receive aspirin and clopidogrel for 12 months after PCI.
OCT-guided PCI
All patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard DAPT
Patients with high bleeding risk will receive aspirin and clopidogrel for 6 months after PCI (unoptimization confirmed in OCT), followed by single antiplatelet therapy thereafter.
Extended DAPT
Patients (with stet unoptimazation results in OCT imaging) receive aspirin and clopidogrel for 12 months after PCI.
OCT-guided PCI
All patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection).
Short DAPT
Patients receive aspirin and clopidogrel for 1 month after PCI. After 1 month, aspirin is discontinued and clopidogrel monotherapy is continued.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of stable angina
* Ability and willingness to provide written informed consent approved by the Institutional Review Board (IRB), and to comply with the study protocol and clinical follow-up schedule
* Age ≥ 19 years
Exclusion Criteria
* Contraindications to antiplatelet therapy or OCT imaging
* Presence of lesions with severe stenosis, heavy calcification, or marked vessel tortuosity that prevent passage of a guidewire or catheter
* Patients with previously implanted coronary stents in the target lesion
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott
INDUSTRY
Korea University Guro Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Park, Soohyung
Assistant Professor, Interventional Cardiologist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiovascular Center, Department of Internal Medicine, Korea University Guro Hospital
Seoul, Gurodong-ro, Guro-gu, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KOR-2023-02
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
No.2025GR0393
Identifier Type: -
Identifier Source: org_study_id