Trials / Completed
CompletedNCT02228564
BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 155 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Percutaneous transluminal angioplasty (PTA) | Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. |
| DEVICE | LIFESTREAM™ covered stent | Implantation of the LIFESTREAM™ covered stent |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2016-12-01
- Completion
- 2018-12-01
- First posted
- 2014-08-29
- Last updated
- 2020-10-08
- Results posted
- 2020-10-08
Locations
20 sites across 3 countries: United States, Germany, New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02228564. Inclusion in this directory is not an endorsement.