Trials / Completed
CompletedNCT00561457
A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease
Detailed description
The study is designed to collect safety and efficacy data on the Bard Luminexx Iliac Stent in a broad patient population having indications for iliac stenting. Effectiveness in this study will be demonstrated by the prevention of Major Adverse Clinical Events (MACE). The composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (\>50%) at nine months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bard Luminexx Iliac Stent and Delivery System | Iliac Stenting |
Timeline
- Start date
- 2003-06-01
- Primary completion
- 2008-01-01
- Completion
- 2008-01-01
- First posted
- 2007-11-21
- Last updated
- 2017-03-01
- Results posted
- 2011-05-04
Source: ClinicalTrials.gov record NCT00561457. Inclusion in this directory is not an endorsement.