Optical Coherence Tomography for Stent Optimization and Its Impact on Short-Duration Dual Antiplatelet Therapy: A Single-Center, Prospective, Exploratory Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to evaluate whether the use of optical coherence tomography (OCT), an advanced intravascular imaging tool, can improve stent implantation results and make it possible to shorten the duration of dual antiplatelet therapy (DAPT) in patients with stable angina who undergo percutaneous coronary intervention (PCI). 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Patients who undergo PCI using a cobalt-chromium everolimus-eluting stent (CoCr-EES)

• 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

Locations
Other Locations
Republic of Korea
Cardiovascular Center, Department of Internal Medicine, Korea University Guro Hospital
RECRUITING
Seoul
Contact Information
Primary
Soohyung Park, MD, PhD
shp503@naver.com
+82-10-3105-3710
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2029-09
Participants
Target number of participants: 130
Treatments
Experimental: Short DAPT
Patients with optimized stent results confirmed by OCT will receive 1 month of dual antiplatelet therapy followed by clopidogrel monotherapy.
Active_comparator: 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.
Active_comparator: 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.
Sponsors
Leads: Korea University Guro Hospital
Collaborators: Abbott

This content was sourced from clinicaltrials.gov

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