Trials / Suspended
SuspendedNCT03175744
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Spectranetics Corporation · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Stellarex DCB | Intervention with the Stellarex DCB |
| DEVICE | PTA Catheter | Intervention with an uncoated Standard PTA |
Timeline
- Start date
- 2017-05-24
- Primary completion
- 2022-04-30
- Completion
- 2025-10-01
- First posted
- 2017-06-05
- Last updated
- 2023-06-22
Locations
21 sites across 5 countries: United States, Australia, Austria, Belgium, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03175744. Inclusion in this directory is not an endorsement.