Trials / Completed
CompletedNCT01844284
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
A Clinical Evaluation of AVJ-301 (Absorb™ BVS), the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Japanese Population
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.
Detailed description
Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | XIENCE PRIME®/XIENCE Xpedition™ | Subjects receiving XIENCE PRIME®/XIENCE Xpedition™ |
| DEVICE | Absorb™ BVS | Subjects receiving Absorb™ BVS |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2015-01-01
- Completion
- 2019-01-16
- First posted
- 2013-05-01
- Last updated
- 2020-10-08
- Results posted
- 2019-02-06
Locations
39 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01844284. Inclusion in this directory is not an endorsement.