Coroflex ISAR 2000 Extended Registry (ISAR2000 Extended)

Launched by B. BRAUN MELSUNGEN AG · Sep 14, 2016

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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