NCT04276389UnknownNot Applicable
OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery After Lesion Preparation With Scoring Balloon - A Prospective Multicenter Cohort Study
Beijing Anzhen Hospital2 sites in 1 country80 target enrollmentStarted: August 1, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Late lumen loss
Study Overview
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 multicenter cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 to 85 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, or silent ischemia.
- •Reference vessel diameter >2.5 mm, and <4.0 mm.
- •Lesion length of <22 mm
- •Written informed consent
Exclusion Criteria
- •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 or Killip≥3)
- •Chronic kidney disease (eGFR <30 ml/min)
- •Lesion length >22 mm, or vessel diameters of <2.5 mm or >4.0 mm
- •Stents covering a major side branch (>2 mm)
- •Left main lesion
- •Graft lesion
- •Aortic-coronary ostial lesion
- •In-stent restenotic lesion
- •Chronic total occlusion
- •Severe calcified lesions.
- •Visible angiographic thrombus
- •Severe comorbidities: eg. malignancy (life expectancy <2 years)
Outcomes
Primary Outcomes
Late lumen loss
Time Frame: 9 months
Evaluated by QCA
Secondary Outcomes
- Rate of binary restenosis(9 months)
- Target lesion failure(9 months)
Investigators
Shao-Ping Nie
Professor of Medicine, Director, Emergency & Critical Care Center
Beijing Anzhen Hospital
Study Sites (2)
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