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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Coroflex® ISAR NEO is intended to be used for

• Patients must be at least 18 years of age AND

• 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 AND

• Patients with Novo lesion length 2-4 mm AND

• Informed consent signed

Locations
Other Locations
France
Centre Hospitalier du Pays d'Aix
RECRUITING
Aix-en-provence
Centre Hospitalier Ajaccio
RECRUITING
Ajaccio
University Hospital Center of Caen
RECRUITING
Caen
Hôpital Albert Schweitzer
RECRUITING
Colmar
Hospitalario Universitario (CHU) de Lille
RECRUITING
Lille
APHP -Hôpital Lariboisière
RECRUITING
Paris
Spain
Hospital Universitario A Coruña
RECRUITING
A Coruña
Hospital Universitario de Badajoz
RECRUITING
Badajoz
Hospital Universitari Germans Trias I Pujol
RECRUITING
Badalona
Hospital Universitario de Cruces
RECRUITING
Barakaldo
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall D Hebron
RECRUITING
Barcelona
Hospital Universitario San Pedro de Alcantara
RECRUITING
Cáceres
Hospital General Universitario de Ciudad Real
RECRUITING
Ciudad Real
Hospital Universitario Juan Ramon Jimenez
RECRUITING
Huelva
Hospital Universitario de Leon
RECRUITING
León
Hospital Universitario Lucus Agusti
RECRUITING
Lugo
Hospital Clinico Universitario Lozano Blesa
RECRUITING
Zaragoza
Contact Information
Primary
koldobika García San Román, MD, PhD
koldobikags@hotmail.com
0034696704643
Backup
FUNDACION EPIC
iepic@fundacionepic.org
0034987876135
Time Frame
Start Date: 2023-08-04
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 3000
Treatments
Coronary Artery Disease (CAD) and high risk of bleeding
Coronary Artery Disease (CAD)
Related Therapeutic Areas
Sponsors
Leads: Fundación EPIC

This content was sourced from clinicaltrials.gov