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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. DESyne DES | Experimental | Test arm: Intervention with DESyne Novolimus-Eluting Coronary Stent DESyne Novolimus Stent System |
|
| 2. Medtronic Endeavor DES | Active Comparator | Control arm: Intervention with Medtronic Endeavor Zotarolimus-Eluting Coronary Stent Medtronic Endeavor Coronary Stent System |
|
| 3. DESyne BD DES | Experimental | Test arm: Intervention with DESyne BD Novolimus-Eluting Coronary Stent DESyne BD Novolimus Stent System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Endeavor Coronary Stent System | Device | coronary stent implantation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent late lumen loss assessed by QCA | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device-oriented Composite Endpoints | 1, 6, 9, and 12 months and annually to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick W Serruys, MD, PhD | Thoraxcentrum, Rotterdam, Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Medical Center | Melbourne | 3168 | Australia | |||
| University Hospital Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26465374 | Result | Iqbal J, Verheye S, Abizaid A, Ormiston J, de Vries T, Morrison L, Toyloy S, Fitzgerald P, Windecker S, Serruys PW. DESyne novolimus-eluting coronary stent is superior to Endeavor zotarolimus-eluting coronary stent at five-year follow-up: final results of the multicentre EXCELLA II randomised controlled trial. EuroIntervention. 2016 Dec 10;12(11):e1336-e1342. doi: 10.4244/EIJY15M10_04. |
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| DESyne BD Novolimus Stent System |
| Device |
coronary stent implantation |
|
| DESyne Novolimus Stent System | Device | coronary stent implantation |
|
| Ghent |
| 9000 |
| Belgium |
| Instituto Dante Pazzanese | São Paulo | 0401210 | Brazil |
| Universitäres Herz- und Gefäßzentrum | Hamburg | 22527 | Germany |
| Thoraxcentrum | Rotterdam | 3015 | Netherlands |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Jagiellonian University | Krakow | 31-501 | Poland |
| University Hospital Bern | Bern | 3010 | Switzerland |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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