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| ID | Type | Description | Link |
|---|---|---|---|
| 02-CECI | |||
| IMA 01 | Other Identifier | Clinica IMA, Buenos Aires, Argentina |
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| Name | Class |
|---|---|
| Eucatech AG | INDUSTRY |
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The success of stent implantation has led to the increasingly widespread use of them in the treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation of stents with improved coating materials and the development of polymers that release different kinds of drugs that prevent the activation and/or proliferation of smooth muscle cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this matter. The new generation of stents with biodegradable polymers and short time of drug release gives new advantages to this therapeutic, multiple studies and registries challenge this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III).
For this reason the present study aims to compare a stainless steel stent with a drug eluting stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.
Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with a stainless steel stent ("euca STS Flex") or a drug-eluting stent (" euca STS Flex DE") with a coating of a biodegradable polymer matrix of hemoparin and paclitaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-BMS | Active Comparator | Bare Metal Stent (Euca STS Flex) |
|
| 2-DES | Experimental | Drug Eluting Stent (Euca STS Flex DE), Paclitaxel Eluting stent with biodegradable polymer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bare Metal Stent | Device | Stainless steel stent |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Stent thrombosis | one year | |
| Paclitaxel allergy | six months | |
| Cost-effectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo E Rodriguez, MD, PHD | Centro de estudios en Cardiologia Intervencionista | Study Chair |
| Carlos Fernandez-Pereira, MD | Centro de estudios en Cardiologia Intervencionista | Study Director |
| Alfredo E Rodriguez, MD, PHD | Centro de Estudios en Cardiologia Internvencionista | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica IMA | Adrogué | Buenos Aires | 1846 | Argentina | ||
| Sanatorio Otamendi y Miroli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2950322 | Background | Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201. | |
| 8041413 | Background | Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801. |
| Label | URL |
|---|---|
| German Cardiac Society | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Drug Eluting Stent | Device | stent coated with the biodegradable polymer matrix hemoparin and paclitaxel |
|
|
| one year |
| Quantitative Coronary Angiography | six months |
| Buenos Aires |
| Buenos Aires |
| 1115 |
| Argentina |
| 11297702 | Background | Serruys PW, Unger F, Sousa JE, Jatene A, Bonnier HJ, Schonberger JP, Buller N, Bonser R, van den Brand MJ, van Herwerden LA, Morel MA, van Hout BA; Arterial Revascularization Therapies Study Group. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med. 2001 Apr 12;344(15):1117-24. doi: 10.1056/NEJM200104123441502. |
| 20824769 | Derived | Rodriguez AE, Vigo CF, Delacasa A, Mieres J, Fernandez-Pereira C, Bernardi V, Bettinoti M, Rodriguez-Granillo AM, Rodriguez-Granillo G, Santaera O, Curotto V, Rubilar B, Tronge J, Palacios IF, Antoniucci D; EUCATAX Investigators. Efficacy and safety of a double-coated paclitaxel-eluting coronary stent: the EUCATAX trial. Catheter Cardiovasc Interv. 2011 Feb 15;77(3):335-42. doi: 10.1002/ccd.22769. Epub 2010 Nov 30. |
| Centro de Estudios en Cardiologia Intervencionista | View source |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |