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The investigators sought to discover which one of the following strategies is the safest for patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous stent; Genous stent; drug eluting stent (paclitaxel).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Paclitaxel eluting balloon (Elutax) + Genous stent |
|
| 2 | Experimental | Uncoated balloon + Genous stent |
|
| 3 | Active Comparator | Drug eluting stent (Taxus stent) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent | Device | Predilatation with paclitaxel-eluting balloon, then stenting of the lesion with Genous stent |
| Measure | Description | Time Frame |
|---|---|---|
| Late luminal loss between the three groups at 6 months angiographic follow up. | 6 months | |
| Percent of stent struts covered by endothelium at optical coherence tomography, during 6 months angiographic follow up. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic restenosis (6 months angiographic follow up). | 6 months | |
| Net adverse clinical events at 6 months (death, myocardial infarction, target lesion revascularization, bleedings as from Acuity scale). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bernardo Cortese, MD | Contact | +39 02 55033507 | bcortese@gmail.com | |
| Ugo Limbruno, MD, PhD | Contact | bcortese@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bernardo Cortese, MD, FESC | Ospedale Maggiore Policlinico, Milano, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Emodinamica, Ospedale della Misericordia | Grosseto | 58100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12957423 | Result | Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, Lopez-Minguez JR, Angel J, Auge JM, Gomez-Recio M, Moris C, Seabra-Gomes R, Perez-Vizcayno MJ, Macaya C; Restenosis Intra-stent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis. J Am Coll Cardiol. 2003 Sep 3;42(5):796-805. doi: 10.1016/s0735-1097(03)00852-0. | |
| 17869634 |
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|
| Percutaneous coronary intervention: Uncoated balloon + Genous stent | Device | Predilatation with uncoated balloon, the stenting with Genous stent. |
|
|
| Percutaneous coronary intervention: Drug eluting stent (Taxus stent) | Device | Predilatation with uncoated balloon, the placement of a Taxus stent. |
|
|
| Result |
| Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5. |
| 15893169 | Result | Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol. 2005 May 17;45(10):1574-9. doi: 10.1016/j.jacc.2005.01.048. |
| 18082503 | Result | Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC. Use of endothelial progenitor cell capture stent (Genous Bio-Engineered R Stent) during primary percutaneous coronary intervention in acute myocardial infarction: intermediate- to long-term clinical follow-up. Am Heart J. 2008 Jan;155(1):128-32. doi: 10.1016/j.ahj.2007.08.031. Epub 2007 Nov 26. |
| 17368152 | Result | Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM, McLaurin BT, Cox DA, Pocock SJ, Ware JH, Feit F, Colombo A, Manoukian SV, Lansky AJ, Mehran R, Moses JW; Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial investigators. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet. 2007 Mar 17;369(9565):907-19. doi: 10.1016/S0140-6736(07)60450-4. |
| 21413116 | Derived | Cortese B, Danzi GB, Piti A, Severi S, Limbruno U. Rationale and design of the randomized, multicenter EREMUS trial, a study that investigates how to achieve low restenosis and early reendothelialization after percutaneous coronary interventions. Catheter Cardiovasc Interv. 2011 Jul 1;78(1):32-7. doi: 10.1002/ccd.22856. Epub 2011 Mar 16. |