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Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Angiolite sirolimus eluting stent to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Angiolite sirolimus eluting stent.
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Angiolite Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease (CAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANGIOLITE | Device | Patients in whom treatment with ANGIOLITE has been attempted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint. Freedom from Target Lesion Failure | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint. Freedom fromTarget Lesion Failure | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). | 7 days |
| Freedom from Accidental dislodgement of the stent |
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Inclusion Criteria:
Exclusion Criteria:
• Not meet inclusion criteria
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Patients treated with ANGIOLITE according to routine hospital practice and following instructions for use
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain | |||
| H. Puerta Del Mar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 74678 | Background | Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available. | |
| 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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Freedom from Accidental dislodgement of the stent |
| During percutaneous coronary intervention (PCI) |
| Freedom from Balloon rupture | Freedom from Balloon rupture | During PCI |
| Freedom from Hypotube rupture | Freedom from Hypotube rupture | During PCI |
| Freedom from Complicated withdrawal | Freedom from Complicated withdrawal | During PCI |
| Freedom from Coronary perforation | Freedom from Coronary perforation | During PCI |
| Freedom from Coronary dissection >C | Freedom from Coronary dissection >C | During PCI |
| Freedom from No reflow | Freedom from No reflow | During PCI |
| Freedom from Coronary thrombosis | Freedom from Coronary thrombosis | During PCI |
| Cadiz |
| 11009 |
| Spain |
| Hospital Universitario de Leon | León | 24080 | Spain |
| Hospital Universitario Virgen de La Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital Clinico Universitario de Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| 8041414 | Background | Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802. |
| 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. |
| 12050336 | Background | Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843. |
| 17296824 | Background | Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007 Mar 8;356(10):998-1008. doi: 10.1056/NEJMoa067193. Epub 2007 Feb 12. |
| 33953973 | Background | Wu X, Li L, He L. Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials. Cardiol Res Pract. 2021 Apr 13;2021:1647635. doi: 10.1155/2021/1647635. eCollection 2021. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |