Trials / Completed
CompletedNCT01113892
Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.
Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Maquet Cardiovascular · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.
Detailed description
The study is a prospective, randomized, single-blind, two-arm, parallel group, multi-center study to evaluate the safety and efficacy of FUSION™ Vascular Graft with Bioline (heparin) coating, compared with EXXCEL Soft ePTFE in a peripheral bypass setting, to support a claim of substantial equivalence.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | vascular grafts | All devices will be used to treat patients with peripheral arterial occlusive disease |
Timeline
- Start date
- 2010-05-17
- Primary completion
- 2012-12-18
- Completion
- 2013-06-04
- First posted
- 2010-04-30
- Last updated
- 2020-05-22
- Results posted
- 2020-05-22
Locations
25 sites across 3 countries: United States, Czechia, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01113892. Inclusion in this directory is not an endorsement.