Fistula Clinical Trial - IN.PACT™ AV Access Post-Approval Study (PAS002)

Status Recruiting

Clinical Trial Summary

Long-term safety will be summarized

Clinical Trial Description

The purpose of this study is to evaluate the long-term safety of the IN.PACT™ AV Access Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity. Patients will be followed for five years. The IN.PACT™ AV Access PAS 002 is required by the Food and Drug Administration (FDA) as a condition of product approval. This study is conducted within Medtronic's post market surveillance platform. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04543539
Study type	Observational [Patient Registry]
Source	Medtronic
Contact	PSR Study Team
Phone	763-526-5668
Email	rs.productsurveillanceregistry@medtronic.com
Status	Recruiting
Phase
Start date	November 13, 2020
Completion date	February 2029

View Details

See also
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