Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656364
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Esprit BTK Post-Approval Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Esprit BTK Post-Approval Study Esprit BTK PAS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
EspritBTKPAS
Brief Summary:
The Esprit BTK PAS is a prospective single-arm multi-center observational study to assess the continued safety and effectiveness of the Esprit BTK Everolimus Eluting Resorbable Scaffold System under commercial use in patients with diseased infrapopliteal lesions causing CLTI Chronic Limb-Threatening Ischemia in a real-world setting The clinical investigation will be conducted at up to 50 sites in the United States US and additional sites may be added outside of the US OUS Approximately 200 patients with a minimum of 50 of patients in the US will be registered in the clinical investigation
Detailed Description:
None
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