NCT04543539

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Long-term safety will be summarized

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort	For the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
COMBINATION_PRODUCT	IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort	For treatment of stenosis in the AV circuit

Timeline

• Start date: 2020-11-13
• Primary completion: 2025-06-03
• Completion: 2029-02-01
• First posted: 2020-09-10
• Last updated: 2025-10-20

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study