Coronary Artery Disease (CAD)
Conditions
Brief summary
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
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.
Interventions
coronary stenting
Sponsors
Charite University, Berlin, Germany
B. Braun Melsungen AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinically driven Target Lesion Revascularization | 9 months | re-intervention of the target lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction rate | 9 months | myocardial infarction |
| Cardiac death rate | 9 months | cardiac death including death of unknown causes |
| Major Adverse Cardiac Events | 9 months | MACE=TLR+MI+cardiac/unknown death |
| Procedural success | immediately after stent implantation (within the first 30 minutes) | Success rate to cross and treat the coronary lesion |
| Stent thrombosis rates | 0-9 months | rates of acute, subacute and 9-month stent thrombosis rates |
| Target lesion revascularization rate | 9 months | TLR=CABG + Re-PCI |
Countries
Germany, Malaysia, Spain
Outcome results
None listed