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

← catalyst calendar

NCT04543539

Sponsored by Medtronic (industry) · MDT — their whole pipeline →.

Phase
Status
Active, not recruiting
Study type
Observational
Enrollment
240actual
Sites
20
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2020-11-13actualWhen the study began enrolling
Primary completion2025-06-03actualThe date the last participant is measured for the primary outcome — the readout window
Study completionFeb 2029estimatedThe whole study's end, after follow-up
First posted2020-09-10actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-10-20actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

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

Interventions

  • Combination product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort
  • Combination product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort

Primary outcome

what the primary-completion date above is the date OF
Infection and Infestations Serious Adverse Events
measured Through 12 months post-index procedure

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