This trial is active, not recruiting.

Condition coronary artery disease (cad)
Treatment stenting with the coroflex isar sirolimus-eluting stent
Sponsor B. Braun Melsungen AG
Collaborator Charite University, Berlin, Germany
Start date January 2014
End date December 2016
Trial size 2000 participants
Trial identifier NCT02629575, AAG-O-H-1408


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

clinically driven Target Lesion Revascularization
time frame: 9 months

Secondary Outcomes

Major Adverse Cardiac Events
time frame: 9 months
Myocardial infarction rate
time frame: 9 months
Cardiac death rate
time frame: 9 months
Target lesion revascularization rate
time frame: 9 months
Procedural success
time frame: immediately after stent implantation (within the first 30 minutes)
Stent thrombosis rates
time frame: 0-9 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - patients suitable for percutaneous coronary intervention with proof of ischemia - at least 18 years of age Exclusion Criteria: - Intolerance to sirolimus and/or probucol - 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

Additional Information

Official title Coroflex ISAR 2000 Postmarket Surveillance Non-Interventional Study
Principal investigator Florian Krackhardt, Dr
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by B. Braun Melsungen AG.