Status:
UNKNOWN
Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
Lead Sponsor:
Liu Bin
Conditions:
Angioplasty
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective mul...
Eligibility Criteria
Inclusion
- 18 to 75 years old Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, silent ischemia or myocardial infarction（≥1month） .
- Reference vessel diameter ≥3.0 mm, and \<4.5mm. Lesion length of ≤20 mm Written informed consent
Exclusion
- Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure \<90mmHg), congestive heart failure (NYHA=4，EF≤35%) Severe valvular heart disease Life expectancy no more than 1 year or factors causing difficulties in clinical follow up Intolerance to aspirin and/or clopidogrel, ticagrelor Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy Leukopenia or thrombopenia A history of peptic ulcer or GI bleeding in the previously Stroke within 6 months prior to the operation A history of severe hepatic or renal failure Stents covering a major side branch (≥2.5 mm need to intervention) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04664283
Start Date
January 1 2021
End Date
December 31 2023
Last Update
December 11 2020
Active Locations (2)
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1
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
2
the Second hospital of Jilin University
Changchun, Jilin, China, 130041