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

NCT04543539 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2025-10-17

No results posted yet for this study

Summary

Long-term safety will be summarized

Conditions

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

Interventions

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

Sponsors & Collaborators

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2025-06-03
Completion
2029-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04543539 on ClinicalTrials.gov