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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
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Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries.
The aim of the study is to assess the safety and efficacy of elective deployment of the Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenting with the Coroflex ISAR sirolimus-eluting stent | Device | coronary stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinically driven Target Lesion Revascularization | re-intervention of the target lesion | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events | MACE=TLR+MI+cardiac/unknown death | 9 months |
| Myocardial infarction rate | myocardial infarction | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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Unselected patients with coronary de-novo and/or restenotic lesions
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| Name | Affiliation | Role |
|---|---|---|
| Florian Krackhardt, MD | Charité Virchow Unversity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité University Hospital | Berlin | 13353 | Germany | |||
| Pusat Perubatan Universiti Malaya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21768546 | Background | Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, Ibrahim T, Fusaro M, Ott I, Schomig A, Laugwitz KL, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial. Circulation. 2011 Aug 2;124(5):624-32. doi: 10.1161/CIRCULATIONAHA.111.026732. Epub 2011 Jul 18. | |
| 33275200 |
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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 |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Cardiac death rate | cardiac death including death of unknown causes | 9 months |
| Target lesion revascularization rate | TLR=CABG + Re-PCI | 9 months |
| Procedural success | Success rate to cross and treat the coronary lesion | immediately after stent implantation (within the first 30 minutes) |
| Stent thrombosis rates | acute, subacute and 9-month stent thrombosis rates | 0-9 months |
| Kuala Lumpur |
| 59100 |
| Malaysia |
| Hospital General Universitario de Ciudad Real | Ciudad Real | 13005 | Spain |
| Derived |
| Nuruddin AAB, Ahmad WAW, Waliszewski M, Heang TM, Bang LH, Yusof AKM, Abidin IZ, Zuhdi AS, Krackhardt F. Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter? Cardiol Ther. 2021 Jun;10(1):175-187. doi: 10.1007/s40119-020-00204-4. Epub 2020 Dec 4. |
| 32702903 | Derived | Krackhardt F, Waliszewski MW, Kherad B, Barth C, Marcelli D. Clinical outcomes following polymer-free sirolimus-eluting stent implantations in unselected patients: A descriptive subgroup analysis in patients with renal impairment. Medicine (Baltimore). 2020 Jul 17;99(29):e21244. doi: 10.1097/MD.0000000000021244. |
| 32212061 | Derived | Krackhardt F, Waliszewski M, Kocka V, Tousek P, Janek B, Hudec M, Lozano F, Roman KG, Del Blanco BG, Mauri J, Heang TM, Ahn TH, Jeong MH, Herberger D, Tomulic V, Levy G, Sebagh L, Rischner J, Pansieri M. Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease. Cardiovasc Drugs Ther. 2020 Jun;34(3):335-344. doi: 10.1007/s10557-020-06963-5. |
| 32080086 | Derived | Krackhardt F, Kocka V, Waliszewski M, Tousek P, Janek B, Trencan M, Krajci P, Lozano F, Roman KG, Otaegui I, Del Blanco BG, Del Olmo VV, Nofrerias EF, Wachowiak L, Heang TM, Ahn TH, Jeong MH, Jung BC, Han KR, Piot C, Sebagh L, Rischner J, Pansieri M, Leschke M. Unrestricted use of polymer-free sirolimus eluting stents in routine clinical practice. Medicine (Baltimore). 2020 Feb;99(8):e19119. doi: 10.1097/MD.0000000000019119. |
| 31929543 | Derived | Krackhardt F, Waliszewski M, Wan Ahmad WA, Kocka V, Tousek P, Janek B, Trencan M, Krajci P, Lozano F, Garcia-San Roman K, Otaegui Irurueta I, Garcia Del Blanco B, Wachowiak L, Vilalta Del Olmo V, Fernandez Nofrerias E, Ho Jeong M, Jung BC, Han KR, Piot C, Sebagh L, Rischner J, Pansieri M, Leschke M, Ahn TH. Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes. PLoS One. 2020 Jan 13;15(1):e0226606. doi: 10.1371/journal.pone.0226606. eCollection 2020. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |