Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)

Coronary Artery Disease Clinical Trial

Official title:

Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03809715
• Other study ID #: AAG-O-H-1803
• Status: Active, not recruiting
• Start date: January 17, 2019
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.

Description:

Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3520
• Est. completion date: June 2025
• Est. primary completion date: March 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Coroflex® ISAR NEO is intended to be used for

• All common significant coronary lesions
• Target lesion length >34mm need to be covered with at least 2 stents
• Patients eligible for this study must be at least 18 years of age.
• The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment.

Exclusion Criteria:

• Intolerance to sirolimus and/or probucol
• Allergy to components of the coating
• Pregnancy and lactation
• Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
• Cardiogenic shock
• Risk of an intraluminal thrombus
• Hemorrhagic 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 PCI 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

Intervention

Device:
• Coroflex® ISAR NEO coronary stent system
treatment of coronary artery disease with Coroflex® ISAR NEO of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts

Locations

Country	Name	City	State
France	Clinique St. Hilaire	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Revascularization (TLR) rate at 12 months		12 months
Secondary	Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)	MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.	12 months
Secondary	Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)		12 months
Secondary	Stent thrombosis rates accumulated up to 12 months	Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.	12 months
Secondary	Rate of bleeding complications accumulated up to 12 months	To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.	12 months
Secondary	Technical/procedural success rate		immediately after procedure