Trials / Completed
CompletedNCT01086228
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,010 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.
Detailed description
The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.
Conditions
- Angina
- Chronic Coronary Occlusion
- Stent Thrombosis
- Vascular Disease
- Myocardial Ischemia
- Coronary Artery Stenosis
- Coronary Disease
- Coronary Artery Disease
- Coronary Restenosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | XIENCE V / PROMUS stent | Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2012-06-01
- Completion
- 2016-08-01
- First posted
- 2010-03-15
- Last updated
- 2018-02-19
- Results posted
- 2018-02-19
Locations
47 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01086228. Inclusion in this directory is not an endorsement.