Arteriovenous FistulaNCT04543539
IN.PACT™ AV Access Post-Approval Study (PAS002)
An observational study of Arteriovenous Fistula and Arteriovenous Fistula Stenosis, run by Medtronic at 20 sites in United States.
Trial summary
Long-term safety will be summarized Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion
- What is being tested?
- IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort and IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
- How many people
- 240 participants
- Where
- 20 sitesUnited States
- Study dates
- 13 Nov 2020to Feb 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients that will have an angioplasty with the IN.PACT™ AV Paclitaxel-Coated PTA Balloon Catheter (IN.PACT™ AV DCB).
Who may be able to join
- Patient is ≥ 21 years of age
Who cannot join
- Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Albany Medical College
Albany, New York, 12084
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109
University of Virginia Medical Center
Charlottesville, Virginia, 22903
University of Iowa
Iowa City, Iowa, 52242
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Cedars-Sinai Heart Institute
Los Angeles, California, 90048
University of Wisconsin-Madison - Meriter Hospital
Madison, Wisconsin, 53713
NCH Healthcare System
Naples, Florida, 34102
Yale New Haven Hospital
New Haven, Connecticut, 06519
The Mount Sinai Hospital
New York, New York, 10029
MUSC Health Dialysis Access Institute
Orangeburg, South Carolina, 29118
Coastal Vascular and Interventional
Pensacola, Florida, 32504
FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374
Oregon Health & Science University Hospital
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Stanford University Medical Center
Stanford, California, 94301
Staten Island University Hospital
Staten Island, New York, 10305
Holy Name Medical Center
Teaneck, New Jersey, 07666
Medstar Washington Hospital
Washington D.C., District of Columbia, 20010
About this study
Long-term safety will be summarized
Read the 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
- Being tested
- IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort, IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
- Medical subject headings
- Arteriovenous Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN.PACT™ AV Drug Coated Balloon (DCB) - Primary CohortCombination product
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.
IN.PACT™ AV Drug Coated Balloon (DCB) - Extended CohortCombination product
For treatment of stenosis in the AV circuit
| Study group | Role | What they receive |
|---|---|---|
| IN.PACT™ AV Access PAS Primary Cohort | The primary cohort consists of enrolled subjects treated with the IN.PACT™ AV DCB according to labeling requirements who meet the inclusion/exclusion criteria for the primary cohort. Receives: Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort | |
| IN.PACT™ AV Access PAS Extended Cohort | The extended cohort consists of enrolled subjects who do not meet the eligibility criteria for the primary cohort and receive the IN.PACT™ AV DCB device for treatment of stenosis in the AV circuit. Receives: Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection and Infestations Serious Adverse Events
Demonstrate Infection and Infestations Serious Adverse Events, including pneumonia, meets the performance goal of 30% in the primary cohort.
Measured: Through 12 months post-index procedure
Secondary outcomes (1)
Mortality Rate
Determine mortality rate
Measured: Through 1, 2, 3, 4, and 5 years post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start13 Nov 2020
- Primary completion3 Jun 2025
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543539
- Sponsor's protocol ID
- IN.PACT™ AV Access PAS002
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2020
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IN.PACT™ AV Access Post-Approval Study (PAS002)
- ClinicalTrials.gov ID
- NCT04543539
- Acronym / sponsor ID
- IN.PACT™ AV Access PAS002
- Conditions
- Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Fistula
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- Feb 2029 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN.PACT™ AV Access PAS Primary Cohort | – | Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary CohortThe primary cohort consists of enrolled subjects treated with the IN.PACT™ AV DCB according to labeling requirements who meet the inclusion/exclusion criteria for the primary cohort. |
| IN.PACT™ AV Access PAS Extended Cohort | – | Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended CohortThe extended cohort consists of enrolled subjects who do not meet the eligibility criteria for the primary cohort and receive the IN.PACT™ AV DCB device for treatment of stenosis in the AV circuit. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients that will have an angioplasty with the IN.PACT™ AV Paclitaxel-Coated PTA Balloon Catheter (IN.PACT™ AV DCB).
Key inclusion criteria (1 listed)
- Patient is ≥ 21 years of age
Key exclusion criteria (1 listed)
- Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN.PACT™ AV Drug Coated Balloon (DCB) - Primary CohortFor 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 Access PAS Primary Cohort |
| IN.PACT™ AV Drug Coated Balloon (DCB) - Extended CohortFor treatment of stenosis in the AV circuit | Combination product | IN.PACT™ AV Access PAS Extended Cohort |
Primary outcome
Infection and Infestations Serious Adverse Events
Time frame: Through 12 months post-index procedure
Demonstrate Infection and Infestations Serious Adverse Events, including pneumonia, meets the performance goal of 30% in the primary cohort.
1 secondary outcome
Mortality Rate
Time frame: Through 1, 2, 3, 4, and 5 years post-index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula and Arteriovenous Fistula Stenosis, run by Medtronic at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection and Infestations Serious Adverse Events (time frame: Through 12 months post-index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.