Trials / Completed
CompletedNCT01425281
ABSORB II Randomized Controlled Trial
ABSORB II RANDOMIZED CONTROLLED TRIAL A Clinical Evaluation to Compare the Safety, Efficacy and Performance of ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System Against XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by de Novo Native Coronary Artery Lesions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 501 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)
Detailed description
In the USA, ABSORB BVS is currently in development at Abbott Vascular. Not available for sale in the US.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System | XIENCE implantation in the treatment of coronary artery disease. |
| DEVICE | Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System | ABSORB BVS implantation in the treatment of coronary artery disease. |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2016-07-01
- Completion
- 2018-05-23
- First posted
- 2011-08-30
- Last updated
- 2019-11-13
- Results posted
- 2019-09-04
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01425281. Inclusion in this directory is not an endorsement.