Trials / Unknown
UnknownNCT03284255
Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study
A Randomized Controlled Trial of the Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in Patients With Coronary Artery Disease: BIOHEART-II
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 431 (actual)
- Sponsor
- Shanghai Bio-heart Biological Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The Bioheart Randomized Controlled Trial is a prospective multicentred paralleled study, which will enroll 430 patients and randomized 1:1 to study group and control group. Aim to assess the efficacy and safety of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System compare with XIENCE stent in the treatment of patients with up to two coronary lesions.
Detailed description
This study is a prospective, multicentred randomized controlled trial, planning to enroll 430 subjects and randomize 1:1 to study group and control group. All subjects will accept clinical evaluation at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year post procedure. All subjects will accept angiographic evaluation at 1 year post procedure, and simutaneously 80 subjects (40 in study group and 40 in control group) will accepted OCT evaluation. To assess the efficacy and safety, the primary endpoint will be in segment late luminal loss at 1 year post procedure, the secondary endpoint is neointima coverage percentage of stent strut (%) at 1 year post procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | study group | study group in which patient will accept the treatment of Bioresorbable Coronary Stent |
| DEVICE | control group | control group in which patient will accept the treatment of Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V® |
Timeline
- Start date
- 2017-09-11
- Primary completion
- 2020-08-30
- Completion
- 2024-08-30
- First posted
- 2017-09-15
- Last updated
- 2019-11-21
Locations
25 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03284255. Inclusion in this directory is not an endorsement.