Status:
UNKNOWN
Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions
Lead Sponsor:
Beijing Hospital
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Brief Summary
Drug-coating balloon (DCB) is a new interventional device for treatment of obstructive coronary artery disease (CAD). There is limited data on the long term efficacy and safety of DCB-only strategy fo...
Detailed Description
DCB has emerged as a new interventional option to treat obstructive CAD. Characterized by non-stent-based local drug delivery system, DCB has several advantages over drug-eluting stent(DES).Paclitaxel...
Eligibility Criteria
Inclusion
- Patient-related criteria：
- Patients with stable angina, unstable angina, myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy;
- Consent to receive clinical follow up at 30 days, 3, 6, 12 and 24 months.
- Consent to receive one angiographic follow up at 24 months after procedure.
- Lesion-related criteria：
- Target coronary lesions without previous intervention therapy;
- The lesions was intervened only with DCB;
- The distance between other lesions requiring intervention therapy and the target lesion must \>10mm.
Exclusion
- Patient-related criteria：
- Severe congestive heart failure\[LVEF \<30% or NYHA( New York Heart Association) III/IV)\]
- Severe valvular heart disease;
- Pregnant or breastfeeding women;
- Life expectancy no more than 1 year or factors causing difficulties in clinical follow up;
- Bleeding predisposition, contraindications of anticoagulants or antiplatelet agents;
- Intorerance to aspirin and/or clopidogrel or other anti platelet drugs;
- Leukopenia or thrombopenia;
- Stroke within 6 months prior to the operation;
- A history of severe hepatic or renal failure.
- Lesion-related criteria ：
- Ostia lesions of left main or right coronary artery;
- Percutaneous coronary intervention of the graft vessel;
- Lesions that are not indications of PTCA(percutaneous transluminal coronary angiography) or other intervention therapy.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04022200
Start Date
August 1 2019
End Date
July 31 2023
Last Update
March 22 2022
Active Locations (1)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730