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IN.PACT™ AV Access IDE Study

NCT03041467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2024-05-29

Study results available
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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.

Conditions

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

Interventions

DEVICE

IN.PACT AV DCB

IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

DEVICE

Standard Balloon Angioplasty

Standard PTA Balloon

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Robert Lookstein, MD · The Mount Sinai Hospital

  • Andrew Holden, MD · Auckland City Hospital

  • Hiroaki Haruguchi, MD · Haruguchi Vascular Access Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2018-12-06
Completion
2023-05-05
FDA Device
Yes

Countries

  • United States
  • Japan
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03041467 on ClinicalTrials.gov