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

NCT ID: NCT03809715

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3520 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-17
• Study Completion Date: 2025-08-15

Brief Summary

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

Detailed 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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rene Koning, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique St. Hilaire

Locations

Clinique St. Hilaire

Rouen, , France

Countries

France

References

Landolff Q, Quillot M, Picard F, Henry P, Sideris G, Bizeau O, Piot C, Jouve B, Rischner J, Mejri M, Charmasson C, Lasserre R, Pouliquen H, Joseph T, Monsegu J, Karsenty B, Martin Yuste V, Richet N, Lapeyre G, Beverelli F, Beygui F, Koning R. In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease. J Interv Cardiol. 2023 Dec 13;2023:8907315. doi: 10.1155/2023/8907315. eCollection 2023.

Reference Type: DERIVED

PMID: 38125031 (View on PubMed)

Other Identifiers

AAG-O-H-1803

Identifier Type: -

Identifier Source: org_study_id