Status:
UNKNOWN
OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 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 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
- 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)
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04276389
Start Date
August 1 2017
End Date
August 31 2020
Last Update
February 19 2020
Active Locations (1)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China, 100029