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NCT03538392 Clinical Trial

Serranator® Alto Post Market Clinical Follow Up (PMCF) Study

Peripheral Arterial Disease Clinical Trial

Official title:
Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03538392
Other study ID # Serranator® Alto PMCF Study
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 2019
Est. completion date December 2019

Study information
Verified date July 2019
Source Cagent Vascular LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - Subject requires angioplasty

- Subject has a lesion in the iliac, femoral, iliofemoral, popliteal artery, or obstructive lesion of native or synthetic arteriovenous dialysis fistulae as per the product indications for use

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Serranator® Alto
Serranator® Alto PTA Serration Balloon Catheter

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cagent Vascular LLC

Outcome
Type Measure Description Time frame Safety issue
Primary Performance Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a diameter stenosis of <50% by visual assessment at the intended target site after using the Serranator® device. The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year.
Secondary Collection of device related Major Adverse Events (MAE) until discharge Safety defined as incidence of device related MAE, defined as amputations or re-interventions (surgical or endovascular) Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first
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