Status:
RECRUITING
Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent
Lead Sponsor:
Asan Medical Center
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Objectives: To assess the safety of tailored antiplatelet therapy (short DAPT followed by P2Y12 inhibitor alone strategy) in patients who received optimized DES implantation guided by intravascular im...
Detailed Description
Objective: To assess the safety of tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) in patients who received optimized DES implantation guided by intravascular imaging (IV...
Eligibility Criteria
Inclusion
- Men or women ≥19 years
- Typical chest pain or objective evidence of myocardial ischemia suitable for PCI
- Significant de novo coronary artery lesions suitable for DES implantation
- Patients who underwent optimized stent implantation either by IVUS or OCT
- Using IVUS
- MSA \>5.5 mm2, or MSA \>90% of the MLA at the distal reference segment
- Plaque burden \<50% with 5 mm of both stent edge
- No edge dissection, thrombus or plaque protrusion/stent area \<10%
- Using OCT
- MSA \>4.5 mm2, or MSA \>90% of the MLA at the distal reference segment
- No significant malapposition
- No significant edge dissection, thrombus or plaque protrusion/stent area \<10%
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
Exclusion
- Angiographic exclusion criteria: any of the followings 1. Bypass graft lesions 2. Lesions in which impaired delivery of imaging catheters is expected:
- Extreme angulation (≥90°) proximal to or within the target lesion.
- Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
- Heavy calcification proximal to or within the target lesion.
- In-stent restenosis
- Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
- Persistent thrombocytopenia (platelet count \<80,000/l)
- Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months
- A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin
- Patients requiring long-term oral anticoagulants or cilostazol
- Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
- A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction
- Life expectancy \< 1 years for any non-cardiac or cardiac causes
- Cardiogenic shock at the index admission
- Patient's pregnant or breast-feeding
- Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
- Unwillingness or inability to comply with the procedures described in this protocol.
Key Trial Info
Start Date :
October 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
3944 Patients enrolled
Trial Details
Trial ID
NCT05418556
Start Date
October 21 2022
End Date
December 31 2028
Last Update
August 27 2024
Active Locations (25)
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1
Bucheon Sejong Hospital
Bucheon-si, South Korea
2
Dong-A University Hospital
Busan, South Korea
3
Inje University Busan Paik Hospital
Busan, South Korea
4
Kosin University Gospel Hospital
Busan, South Korea