NCT03809715

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,520 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-17
• Primary completion: 2024-05-31
• Completion: 2025-08-15
• First posted: 2019-01-18
• Last updated: 2026-01-08

Locations

1 site across 1 country: France