IN.PACT™ AV Access IDE Study

Status Completed

Clinical Trial Summary

To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity.

Clinical Trial Description

This is a prospective, global, multi-center, single-blinded, 1:1 randomized clinical trial evaluating the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity. The trial will be conducted in up to 30 sites in the United States, Japan, and New Zealand. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03041467
Study type	Interventional
Source	Medtronic Endovascular
Contact
Status	Completed
Phase	N/A
Start date	April 25, 2017
Completion date	May 5, 2023

View Details

See also
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