IN.PACT™ AV Access Post-Approval Study (PAS002)
Purpose
Long-term safety will be summarized
Conditions
- Arteriovenous Fistula
- Arteriovenous Fistula Stenosis
- Arteriovenous Fistula Occlusion
- Fistula
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Exclusion Criteria for Extended Cohort: - Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
| 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. |
|
Recruiting Locations
Medstar Washington Hospital
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Contact:
Nelson Bernardo, MD
Nelson Bernardo, MD
More Details
- Status
- Recruiting
- Sponsor
- Medtronic
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.