Arteriovenous Fistula, Arteriovenous Fistula Occlusion, Arteriovenous Fistula Stenosis, Fistula
Conditions
Brief 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.
Interventions
COMBINATION_PRODUCTIN.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_PRODUCTIN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
For treatment of stenosis in the AV circuit
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Cohort Inclusion Criteria: * Patient is ≥ 21 years of age * Patient has a mature native AV fistula created ≥ 60 days prior to the index procedure * Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction * Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be included provided they meet all of the following criteria: a. Separated by a gap of ≤ 30 mm (3 cm), b. Total combined lesion length, including 30 mm gap, ≤ 100 mm, c. Able to be treated as a single lesion * Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate) * Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as: Residual stenosis of ≤ 30% AND Absence of a flow limiting dissection or perforation AND No extravasation requiring treatment Primary Cohort
Exclusion criteria
* Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children * Patient is receiving immunosuppressive therapy * Patient has an infected AV access or systemic infection * Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion * Patient with target lesion located central to the axillosubclavian junction * Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access * Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site * Target lesion is located within a bare metal or covered stent * Patients with known allergies or sensitivities to paclitaxel * Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated * Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy * Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study * Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation * Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19 Inclusion Criteria for Extended Cohort: * Patient is ≥ 21 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection and Infestations Serious Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | Through 1, 2, 3, 4, and 5 years post-index procedure | Determine mortality rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Extended Cohort - Characterize Infections and Infestations Serious Adverse Events | Through 1-year and all-cause mortality through 5-years post-index procedure | Characterize infections and infestations Serious Adverse Events, including pneumonia. |
Countries
United States
Outcome results
None listed