Trials / Completed
CompletedNCT00792753
Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study "EXCELLA II STUDY"
A Randomized, Single Blind, Consecutive Enrollment Evaluation of the Elixir Novolimus-Eluting Coronary Stent System With Durable Polymer Compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment Of Patients With De Novo Native Coronary Artery Lesions And A Randomized, Consecutive Enrollment Evaluation of the Elixir Novolimus-Eluting Coronary Stent System With Bioabsorbable Polymer Compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment Of Patients With De Novo Native Coronary Artery Lesions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 360 (actual)
- Sponsor
- Elixir Medical Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Randomized Study To evaluate the safety and effectiveness of the Elixir Medical DESyne Novolimus-Eluting Coronary Stent System with Durable Polymer through the assessment of clinical, angiographic and IVUS endpoints as compared to the concurrently enrolled Medtronic Zotarolimus-Eluting Coronary Stent System in a randomized, single blind study of up to 200 male and female patients. In a Continued Access Registry of up to 100 patients receiving the DESyne Stent clinical-only endpoints will be evaluated. To evaluate the safety and effectiveness of the Elixir Novolimus-Eluting Coronary Stent System with bioabsorbable polymer as compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System control through clinical and angiographic endpoints.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medtronic Endeavor Coronary Stent System | coronary stent implantation |
| DEVICE | DESyne BD Novolimus Stent System | coronary stent implantation |
| DEVICE | DESyne Novolimus Stent System | coronary stent implantation |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2011-11-01
- Completion
- 2014-03-08
- First posted
- 2008-11-18
- Last updated
- 2020-04-08
Locations
8 sites across 8 countries: Australia, Belgium, Brazil, Germany, Netherlands, New Zealand, Poland, Switzerland
Source: ClinicalTrials.gov record NCT00792753. Inclusion in this directory is not an endorsement.