Trials / Completed
CompletedNCT02110524
CVI Drug Coated Balloon First In Human Trial
Prospective, Controlled, Multi-Center, Open, Single Arm Study for the Treatment of Subjects Presenting De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using a Paclitaxel-Coated Percutaneous Angioplasty Catheter
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Spectranetics Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or popliteal arteries. The primary endpoint for this analysis is late lumen loss at six (6) months.
Detailed description
Prospective, controlled, multi-center, open, single arm study Main cohort: 50; pre-specified treatment group: 30. Total patients: 80
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous Transluminal Angioplasty |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2012-09-01
- Completion
- 2014-12-01
- First posted
- 2014-04-10
- Last updated
- 2015-02-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02110524. Inclusion in this directory is not an endorsement.