Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621524
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
EucaLimus Post-Market Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Coronary Angioplasty With Sirolimus Drug-coated Stent System to Treat Patients With Symptomatic Ischemic Coronary Heart Disease a PMCF Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The multicenter prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention PCI and are intended to be or treated by the Eucalimus sirolimus eluting PTCA stent according to the Instructions for Use as part of routine clinical care Approximately 251 patients from 5-10 centers in Europe and Asia will be entered into the registry Patients entered into the registry are followed for three years The registry is considered finished when all patients have completed the 36-month follow-up
A follow-up is scheduled at the following timepoints immediately post-procedure 30 days 6 months 12 months 24 months and 36 months Follow-up is obtained by telephone contact with the patient or at a planned hospital visit
A follow-up is scheduled at the following timepoints immediately post-procedure 30 days 6 months 12 months 24 months and 36 months Follow-up is obtained by telephone contact with the patient or at a planned hospital visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None