Coroflex ISAR 2000 Extended Registry (ISAR2000 Extended)

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT02905214
• Date of registration: 14/09/2016
• Prospective Registration: No
• Primary sponsor: B. Braun Melsungen AG
• Public title: Coroflex ISAR 2000 Extended Registry (ISAR2000 Extended)
• Scientific title: Coroflex ISAR 2000 Extended Postmarket Surveillance Non-Interventional Study
• Date of first enrolment: January 2016
• Target sample size: 4369
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02905214
• Study type: Observational

Countries of recruitment

Germany, Malaysia, Spain

Contacts

• Name: Florian Krackhardt, MD
• Affiliation: Charité Virchow Unversity Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease (CAD)

Intervention(s)

Device: stenting with the Coroflex ISAR sirolimus-eluting stent

Primary Outcome(s)

clinically driven Target Lesion Revascularization [Time Frame: 9 months]

Secondary Outcome(s)

Myocardial infarction rate [Time Frame: 9 months]

Cardiac death rate [Time Frame: 9 months]

Major Adverse Cardiac Events [Time Frame: 9 months]

Procedural success [Time Frame: immediately after stent implantation (within the first 30 minutes)]

Stent thrombosis rates [Time Frame: 0-9 months]

Target lesion revascularization rate [Time Frame: 9 months]

Secondary ID(s)

AAG-O-H-1601

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Charite University, Berlin, Germany