Coroflex ISAR 2000 Extended Registry (ISAR2000 Extended)

Completed

• Conditions: Coronary Artery Disease (CAD)

• Registration Number: NCT02905214
• Lead Sponsor: B. Braun Melsungen AG

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-19
• Primary Completion: 2018-12
• Study Completion: 2021-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4369

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinically driven Target Lesion Revascularization	9 months	re-intervention of the target lesion

Secondary Outcome Measures

Name	Time	Method
Target lesion revascularization rate	9 months	TLR=CABG + Re-PCI
Myocardial infarction rate	9 months	myocardial infarction
Cardiac death rate	9 months	cardiac death including death of unknown causes
Procedural success	immediately after stent implantation (within the first 30 minutes)	Success rate to cross and treat the coronary lesion
Major Adverse Cardiac Events	9 months	MACE=TLR+MI+cardiac/unknown death
Stent thrombosis rates	0-9 months	acute, subacute and 9-month stent thrombosis rates

Trial Locations

Locations (3)

Pusat Perubatan Universiti Malaya; 🇲🇾 Kuala Lumpur, Malaysia

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Charité University Hospital; 🇩🇪 Berlin, Germany