Trials / Active Not Recruiting
Active Not RecruitingNCT02460042
Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)
CONSEQUENT ALL COMERS Clinical PMCF on Peripheral Arteries Treated With SeQuent® Please OTW Paclitaxel Coated Balloon Catheter in an All Comer Patient Population
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 960 (actual)
- Sponsor
- B. Braun Melsungen AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries. It is the intention of this trial to treat suitable target lesions with drug coated balloon (DCB) only.
Detailed description
This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | drug coated balloon angioplasty | percutaneous transluminal angioplasty with peripheral balloon catheters |
| DEVICE | SeQuent® Please OTW Paclitaxel Coated Balloon Catheter |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2018-12-01
- Completion
- 2025-12-01
- First posted
- 2015-06-02
- Last updated
- 2025-02-11
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02460042. Inclusion in this directory is not an endorsement.