Trials / Completed
CompletedNCT02531230
"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes
"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes After Plain Old Balloon Angioplasty (POBA) and/or Drug Coated Balloon (DCB) Treatment in the Infra-inguinal Position With the objectiVE to Implant Multiple Stent Segments
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (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 Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA) and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2 \& P3)
Detailed description
This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VascuFlex Multi-LOC® | Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-07-01
- Completion
- 2017-08-01
- First posted
- 2015-08-24
- Last updated
- 2018-10-10
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02531230. Inclusion in this directory is not an endorsement.