Coroflex ISAR 2000 Extended Registry (ISAR2000 Extended)

Coronary Artery Disease (CAD) Clinical Trial

Official title:

Coroflex ISAR 2000 Extended Postmarket Surveillance Non-Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905214
• Other study ID #: AAG-O-H-1601
• Status: Completed
• Start date: January 2016
• Est. completion date: December 2021

Study information

• Verified date: February 2022
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4369
• Est. completion date: December 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)

Intervention

Device:
• stenting with the Coroflex ISAR sirolimus-eluting stent
coronary stenting

Locations

Country	Name	City	State
Germany	Charité University Hospital	Berlin
Malaysia	Pusat Perubatan Universiti Malaya	Kuala Lumpur
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real

Sponsors (2)

Lead Sponsor	Collaborator
B. Braun Melsungen AG	Charite University, Berlin, Germany

Countries where clinical trial is conducted

Germany,  Malaysia,  Spain, 

References & Publications (1)

Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, Ibrahim T, Fusaro M, Ott I, Schömig A, Laugwitz KL, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial. Circulation. 2011 Aug 2;124(5):624-32. doi: 10.1161/CIRCULATIONAHA.111.026732. Epub 2011 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinically driven Target Lesion Revascularization	re-intervention of the target lesion	9 months
Secondary	Major Adverse Cardiac Events	MACE=TLR+MI+cardiac/unknown death	9 months
Secondary	Myocardial infarction rate	myocardial infarction	9 months
Secondary	Cardiac death rate	cardiac death including death of unknown causes	9 months
Secondary	Target lesion revascularization rate	TLR=CABG + Re-PCI	9 months
Secondary	Procedural success	Success rate to cross and treat the coronary lesion	immediately after stent implantation (within the first 30 minutes)
Secondary	Stent thrombosis rates	acute, subacute and 9-month stent thrombosis rates	0-9 months