Coronary Angioplasty With Sirolimus Drug-coated Stent System to Treat Patients With Symptomatic Ischemic Coronary Heart Disease: a PMCF Study.
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the Eucalimus sirolimus eluting PTCA stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Eucalimus PTCA stent in routine clinical practice.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Consecutive patients intended to be, or treated by EucaLimus as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.
Locations
Other Locations
Malaysia
Institut Jantung Negara
RECRUITING
Kuala Lumpur
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Reina Sofía
RECRUITING
Córdoba
Bellvitge University Hospital
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Complejo Hospitalario Universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Contact Information
Primary
Jenny Chong, BS
jchong@orbusneich.com
+6012 298-0651
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2028-10
Participants
Target number of participants: 251
Treatments
Device: EucaLimus coronary stent system
The EucaLimus coronary stent system is a drug-coated coronary stent system, indicated for use in patients with symptomatic ischaemic coronary heart disease due to de novo lesions or restenosed lesions of the coronary arteries.
Related Therapeutic Areas
Sponsors
Collaborators: Centre Européen de Recherche Cardiovasculaire, Eucatech AG
Leads: OrbusNeich