Trials / Completed
CompletedNCT03409731
Absorb GT1 Japan PMS
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.
Conditions
- Ischemic Heart Disease
- Angina Pectoris
- Coronary Artery Disease
- Coronary Artery Occlusion
- Myocardial Ischemia
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ABSORB GT1 BVS | Patients receiving Absorb GT1 BVS |
Timeline
- Start date
- 2016-12-13
- Primary completion
- 2023-02-06
- Completion
- 2023-02-06
- First posted
- 2018-01-24
- Last updated
- 2024-08-06
- Results posted
- 2019-01-03
Locations
15 sites across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03409731. Inclusion in this directory is not an endorsement.