NCT05698732

Coroflex® ISAR NEO PMCF Study

Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

Detailed description

The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Conditions

• Coronary Artery Disease (CAD)
• Ischemic Heart Disease

Interventions

Type	Name	Description
DEVICE	Coroflex® ISAR NEO coronary stent system	Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted

Timeline

• Start date: 2023-08-04
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2023-01-26
• Last updated: 2026-02-17

Locations

20 sites across 2 countries: France, Spain