NCT02305472

NeoVas Bioresorbable Coronary Scaffold Registry Study

Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With de Novo Coronary Artery Lesion (NeoVas): a Single Arm Registry Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 825 (estimated)
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The NeoVas Bioresorbable Coronary Scaffold Registry Trial is a prospective, multi-center, single arm registry trial based on the NeoVas FIM study which verified the safety and effectiveness of NeoVas initially. This study is to evaluate the safety and effectiveness of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion.

Detailed description

Approximately 825 subjects will be enrolled and receive NeoVas BCS(Lepu Medical Technology (Beijing) Co.,Ltd). Subjects will have clinical follow-up at 30, 90, 180 and 270 days and at 1,2,3,4 and 5 years. The primary endpoint is target lesion failure(TLF) at 1 year follow-up.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	NeoVas BCS	Subjects receiving NeoVas BCS

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-09-01
• Completion: 2020-09-01
• First posted: 2014-12-02
• Last updated: 2017-03-09

Locations

27 sites across 1 country: China