Trials / Completed
CompletedNCT01489449
Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 210 (actual)
- Sponsor
- University Hospital, Saarland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.
Detailed description
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI. Primary efficacy endpoint will be MACE (cardiac mortality, reinfarction, and target lesion revascularization) after 9 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Stent | bare metal stent implantation, any bare metal stent is allowed from different companies |
| COMBINATION_PRODUCT | SeQuent(R) Please coated balloon | Angioplasty with Drug coated balloon (DCB) |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2018-06-23
- Completion
- 2022-06-23
- First posted
- 2011-12-09
- Last updated
- 2023-05-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01489449. Inclusion in this directory is not an endorsement.