Trials / Completed
CompletedNCT00967902
Safety and Effectiveness Study of Combo Bio-engineered Sirolimus Eluting Stent
The REMEDEE Study: A Prospective, Randomized Study to Evaluate the Safety and Efficacy of an Abluminal Sirolimus Coated Bio-engineered Stent (Combo Bio-engineered Sirolimus Eluting Stent)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- OrbusNeich · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery lesions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | coronary stenting | Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2011-07-01
- Completion
- 2015-09-01
- First posted
- 2009-08-28
- Last updated
- 2016-03-29
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT00967902. Inclusion in this directory is not an endorsement.