Status:
COMPLETED
Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Up to 80 years
Phase:
NA
Brief Summary
This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding r...
Detailed Description
This is a pilot study that aim to enroll 60 subjects with high bleeding risk. All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1 randomization either to NSE predil...
Eligibility Criteria
Inclusion
- De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test;
- Coronary artery disease (CAD) patients with high risk of bleeding
Exclusion
- Previous coronary artery bypass graft (CABG) patients
- Stent implantation in the target vessel
- Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
- Acute ST segment elevation myocardial infarction (STEMI) within 48 hours
- Contraindications to contrast media, antiplatelet therapy, or paclitaxel
- Cardiac shock
- Pregnancy
- Expected life less than 12 months
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03817801
Start Date
July 30 2019
End Date
December 30 2021
Last Update
April 26 2022
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006