NCT03041467

IN.PACT™ AV Access IDE Study

Randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arteriovenous Fistula Stenosis
• Arteriovenous Fistula Occlusion
• Arteriovenous Fistula
• Fistula

Interventions

Type	Name	Description
DEVICE	IN.PACT AV DCB	IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
DEVICE	Standard Balloon Angioplasty	Standard PTA Balloon

Timeline

• Start date: 2017-04-25
• Primary completion: 2018-12-06
• Completion: 2023-05-05
• First posted: 2017-02-02
• Last updated: 2024-05-29
• Results posted: 2020-02-27

Locations

29 sites across 3 countries: United States, Japan, New Zealand

Regulatory

• FDA-regulated device study