Trials / Completed
CompletedNCT02629575
Coroflex ISAR 2000 Registry
Coroflex ISAR 2000 Postmarket Surveillance Non-Interventional Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,877 (actual)
- Sponsor
- B. Braun Melsungen AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries
Detailed description
The aim of the study is to assess the safety and efficacy of elective deployment of the Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | stenting with the Coroflex ISAR sirolimus-eluting stent | coronary stenting |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2016-12-01
- Completion
- 2017-12-01
- First posted
- 2015-12-14
- Last updated
- 2018-03-13
Locations
3 sites across 3 countries: Germany, Malaysia, Spain
Source: ClinicalTrials.gov record NCT02629575. Inclusion in this directory is not an endorsement.