NCT04565561

Bioabsorbable Scaffold vs Drug-coated Balloon for Coronary de Novo Lesions in STEMI: Prospective Observational Trial

Neovas Versus DCB for Coronary de Novo Lesions in Patients With STEMI: a Prospective Observational Clinical Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. To study the advantages and disadvantages of Neovas BRS and DCB in interventional treatment of de novo lesions in STEMI patients, in order to better guide the clinical. 2. To explore the safety of Neovas BRS in interventional treatment of ide novo lesions in STEMI patients. 3. To explore the safety of DCB in interventional treatment of de novo lesions in STEMI patients.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-01-01
• Completion: 2022-12-01
• First posted: 2020-09-25
• Last updated: 2020-09-25

Locations

1 site across 1 country: China