NCT02305485

NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial

Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With Denovo Coronary Artery Lesion (NeoVas): Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (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 Randomized Controlled Trial is a prospective, multi-center, randomized trial. The study compares NeoVas sirolimus-eluting bioresorbable coronary scaffold with XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) to evaluate the safety and efficacy of NeoVas in the treatment of patients with de novo coronary lesion.

Detailed description

Approximately 560 subjects will be randomly enrolled at a 1:1 ratio, patients in experimental group receiving NeoVas BCS(Lepu Medical Technology (Beijing) Co.,Ltd), and subjects in control group receiving XIENCE PRIME EECSS(Abbott Vascular, Inc). Subjects will have clinical follow-up at 30, 90, 180 and 270 days and at 1,2,3,4 and 5 years. All subjects will undergo coronary angiography at 1 year post-index procedure. The primary endpoint is in-segment late lumen loss(LLL) at 1 year follow-up. Among the RCT study, a subgroup study is designed to evaluate the functional recovery of vasomotion before and after the complete degradation of the NeoVas Bioresorbable Coronary Scaffold with the aid of angiography, OCT and FFR. The subgroup study will be performed in two centers and 160 subjects will be enrolled on a 1:1 randomization basis. Subjects will receive angiography and OCT examination before procedure, and will receive angiography, OCT and FFR after procedure and at 1, 3 years follow-up.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	NeoVas BCS	Subjects receiving NeoVas BCS
DEVICE	XIENCE PRIME EECSS	Subjects receiving XIENCE PRIME EECSS

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-12-01
• Completion: 2020-06-01
• First posted: 2014-12-02
• Last updated: 2016-12-08

Locations

27 sites across 1 country: China