NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial
NCT02305485 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560
Last updated 2016-12-08
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.
Conditions
Interventions
- DEVICE
-
NeoVas BCS
Subjects receiving NeoVas BCS
- DEVICE
-
XIENCE PRIME EECSS
Subjects receiving XIENCE PRIME EECSS
Sponsors & Collaborators
-
Lepu Medical Technology (Beijing) Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yaling Han, MD · The general hospital of Shenyang military region
-
Guosheng Fu · Sir Run Run Shaw Hospital
-
Bo Xu · Beijing Fuwai hospital, National center for cardiovascular diseases China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2016-12-31
- Completion
- 2020-06-30
Countries
- China
Study Locations
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