Bioabsorbable Scaffold vs Drug-coated Balloon for Coronary de Novo Lesions in STEMI: Prospective Observational Trial
NCT04565561 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40
Last updated 2020-09-25
Summary
a prospective, single center, observational clinical trail. Aim to to compare the efficacy and safety of the Bioabsorbable scaffold (BRS) Neovas BRS and Drug-coating balloon (DCB) in the treatment of STEMI patients with coronary artery disease and to further evaluate the safety and effectiveness of the two new interventional methods in STEMI intervention, so as to better guide clinical practice.
Conditions
Interventions
- DEVICE
-
Neovas BRS or DCB
All STEMI patients were predilated (including predilated balloon or cutting balloon) before randomization. Thrombus aspiration was determined by the surgeon according to the specific situation. Sufficient predilation criteria: the following two conditions must be met: A. residual stenosis \< 30%; B. no flow limiting dissection or TIMI grade 2-3.
Sponsors & Collaborators
-
Shenzhen People's Hospital
lead OTHER
Principal Investigators
-
yaowang lin, master · Shenzhen People's Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-01
- Primary Completion
- 2022-01-01
- Completion
- 2022-12-01
Countries
- China
Study Locations
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