stenting with the Coroflex ISAR sirolimus-eluting stent
Devicecoronary stenting
Other names: Coroflex ISAR
NCT Number: NCT02629575
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
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Notify Me18 year and older
All sexes
Observational
Charité University Hospital, Berlin, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
coronary stenting
Other names: Coroflex ISAR
Time frame: 9 months
re-intervention of the target lesion
Time frame: 9 months
MACE=TLR+MI+cardiac/unknown death
Time frame: 9 months
myocardial infarction
Time frame: 9 months
cardiac death including death of unknown causes
Time frame: 9 months
TLR=CABG + Re-PCI
Time frame: immediately after stent implantation (within the first 30 minutes)
Success rate to cross and treat the coronary lesion
Time frame: 0-9 months
rates of acute, subacute and 9-month stent thrombosis rates
B. Braun Melsungen AG
Industry
Coroflex ISAR 2000 Postmarket Surveillance Non-Interventional Study
Acronym: ISAR2000
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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