Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-02 @ 6:29 AM
Study NCT ID:
NCT03538392
Status:
WITHDRAWN
Last Update Posted:
2020-04-10
First Post:
2018-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Sponsor:
Cagent Vascular LLC
Organization:
Study Overview
Official Title:
Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Product not available, study withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
Detailed Description:
Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: