Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2877 participants
OBSERVATIONAL
2014-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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stenting with the Coroflex ISAR sirolimus-eluting stent
coronary stenting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at least 18 years of age
Exclusion Criteria
* Allergy to components of the coating
* Pregnancy and lactation
* Complete occlusion of the treatment vessel
* Severely calcified stenosis
* Cardiogenic shock
* Risk of an intraluminal thrombus
* Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
* Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
* Severe allergy to contrast media
* Lesions which are untreatable with PTCA or other interventional techniques
* Patients with an ejection fraction of \< 30 %
* Vascular reference diameter \< 2.00 mm
* Treatment of the left stem (first section of the left coronary artery)
* Indication for a bypass surgery
* Contraindication for whichever accompanying medication is necessary
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
B. Braun Melsungen AG
INDUSTRY
Responsible Party
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Principal Investigators
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Florian Krackhardt, Dr
Role: PRINCIPAL_INVESTIGATOR
Charité Virchow Unversity Hospital
Locations
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Charité University Hospital
Berlin, , Germany
Pusat Perubatan Universiti Malaya
Kuala Lumpur, , Malaysia
Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
Krackhardt F, Waliszewski M, Rischner J, Piot C, Pansieri M, Ruiz-Poveda FL, Boxberger M, Noutsias M, Rios XF, Kherad B. Nine-month clinical outcomes in patients with diabetes treated with polymer-free sirolimus-eluting stents and 6-month vs. 12-month dual-antiplatelet therapy (DAPT). Herz. 2019 Aug;44(5):433-439. doi: 10.1007/s00059-017-4675-x. Epub 2018 Jan 22.
Kherad B, Waliszewski M, Leschke M, Kader MA, Bang LH, Ruiz-Poveda FL, Pieske B, Krackhardt F. 9-month results of polymer-free sirolimus eluting stents in young patients compared to a septuagenarian and octogenarian all-comer population. J Interv Cardiol. 2018 Jun;31(3):338-344. doi: 10.1111/joic.12472. Epub 2017 Dec 4.
Krackhardt F, Rosli MA, Leschke M, Schneider A, Sperling C, Heang TM, Pons M, Sousa PJ, Kherad B, Waliszewski M. Propensity score matched all comers population treated with ultra-thin strut bare metal and sirolimus-probucol coated drug-eluting stents of identical stent architecture. Catheter Cardiovasc Interv. 2018 Jun;91(7):1221-1228. doi: 10.1002/ccd.27306. Epub 2017 Sep 25.
Krackhardt F, Kocka V, Waliszewski MW, Utech A, Lustermann M, Hudec M, Studencan M, Schwefer M, Yu J, Jeong MH, Ahn T, Wan Ahmad WA, Boxberger M, Schneider A, Leschke M. Polymer-free sirolimus-eluting stents in a large-scale all-comers population. Open Heart. 2017 Jun 6;4(2):e000592. doi: 10.1136/openhrt-2017-000592. eCollection 2017.
Other Identifiers
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AAG-O-H-1408
Identifier Type: -
Identifier Source: org_study_id
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