Coroflex ISAR 2000 Registry

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Coroflex ISAR 2000 Postmarket Surveillance Non-Interventional Study

Conditions
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Coronary Artery Disease (CAD)

Intervention / Treatment
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* Device: stenting with the Coroflex ISAR sirolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: stenting with the Coroflex ISAR sirolimus-eluting stent|coronary stenting|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinically driven Target Lesion Revascularization | re-intervention of the target lesion | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events | MACE=TLR+MI+cardiac/unknown death | 9 months | 
| Myocardial infarction rate | myocardial infarction | 9 months | 
| 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 | rates of acute, subacute and 9-month stent thrombosis rates | 0-9 months |