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To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in diameter.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Artery Stenting | Device | Initial implant of drug eluting stent (zotarolimus) |
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac event (MACE) rate | 30 days, 4, 6, 9 & 12 months | |
| Acute success (device, lesion, and procedure) | 4 or 9 Months | |
| Target vessel failure (TVF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Meredith, Professor | Monash Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Medical Centre | Melbourne | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23523454 | Derived | Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20. | |
| 23468513 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| 9 months |
| Target lesion revascularization (TLR) | 9 months |
| Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS) | 4 or 9 months |
| Pharmacokinetic parameters | last measurement at 60 days |
| Angiographic parameters (in-stent and in-segment) | 4 or 9 months |
| Derived |
| Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6. |
| 21586691 | Derived | Waseda K, Ako J, Yamasaki M, Koizumi T, Sakurai R, Hongo Y, Koo BK, Ormiston J, Worthley SG, Whitbourn RJ, Walters DL, Meredith IT, Fitzgerald PJ, Honda Y. Impact of polymer formulations on neointimal proliferation after zotarolimus-eluting stent with different polymers: insights from the RESOLUTE trial. Circ Cardiovasc Interv. 2011 Jun;4(3):248-55. doi: 10.1161/CIRCINTERVENTIONS.110.957548. Epub 2011 May 17. |
| 20689221 | Derived | Waseda K, Ako J, Yamasaki M, Koizumi T, Ormiston J, Worthley SG, Whitbourn RJ, Walters DL, Honda Y, Meredith IT, Fitzgerald PJ; RESOLUTE Trial Investigators. Short- and mid-term intravascular ultrasound analysis of the new zotarolimus-eluting stent with durable polymer - results from the RESOLUTE trial -. Circ J. 2010 Oct;74(10):2097-102. doi: 10.1253/circj.cj-10-0063. Epub 2010 Aug 3. |
| 20142198 | Derived | Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A. Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention. 2010 Feb;5(7):826-32. doi: 10.4244/eijv5i7a138. |
| 19850258 | Derived | Meredith IT, Worthley S, Whitbourn R, Walters DL, McClean D, Horrigan M, Popma JJ, Cutlip DE, DePaoli A, Negoita M, Fitzgerald PJ; RESOLUTE Investigators. Clinical and angiographic results with the next-generation resolute stent system: a prospective, multicenter, first-in-human trial. JACC Cardiovasc Interv. 2009 Oct;2(10):977-85. doi: 10.1016/j.jcin.2009.07.007. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |