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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


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

See also
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