IN.PACT™ AV Access Post-Approval Study (PAS002)
Study Details
Study Description
Brief Summary
Long-term safety will be summarized
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
| 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. |
Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
For treatment of stenosis in the AV circuit
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Mortality Rate [Through 1, 2, 3, 4, and 5 years post-index procedure]
Determine mortality rate
Other Outcome Measures
- 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.
Eligibility Criteria
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 or relevant history of COVID-19
Inclusion Criteria for Extended Cohort:
- Patient is ≥ 21 years of age
Exclusion Criteria for Extended Cohort:
- Patient has an active COVID-19 infection or relevant history of COVID-19
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University Medical Center | Stanford | California | United States | 94301 |
| 2 | Medstar Washington Hospital | Washington | District of Columbia | United States | 20010 |
| 3 | Coastal Vascular and Interventional | Pensacola | Florida | United States | 32504 |
| 4 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 5 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 6 | Holy Name Medical Center | Teaneck | New Jersey | United States | 07666 |
| 7 | Albany Medical College | Albany | New York | United States | 12084 |
| 8 | Staten Island University Hospital | Staten Island | New York | United States | 10305 |
| 9 | Oregon Health & Science University Hospital | Portland | Oregon | United States | 97239 |
| 10 | Dialysis Access Institute | Orangeburg | South Carolina | United States | 29118 |
| 11 | Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
| 12 | University of Virginia Medical Center | Charlottesville | Virginia | United States | 22903 |
Sponsors and Collaborators
- Medtronic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IN.PACT™ AV Access PAS002