Trials / Completed
CompletedNCT03721939
BEnefit of Arterial Preparation by LONGitudinal Scoring
BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- VentureMed Group Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FLEX Scoring Catheter | Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty. |
Timeline
- Start date
- 2018-10-24
- Primary completion
- 2023-01-25
- Completion
- 2024-03-04
- First posted
- 2018-10-26
- Last updated
- 2024-12-12
Locations
1 site across 1 country: Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03721939. Inclusion in this directory is not an endorsement.