NCT04543539Active, not recruitingNot Applicable
IN.PACT™ AV Access Post-Approval Study (PAS002)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Medtronic
- Enrollment
- 240
- Locations
- 20
- Primary Endpoint
- Infection and Infestations Serious Adverse Events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Mortality Rate(Through 1, 2, 3, 4, and 5 years post-index procedure)
Investigators
Study Sites (20)
Loading locations...
Similar Trials
Recruiting
Phase 4
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate CancerProstate CancerNCT05803941Novartis Pharmaceuticals700
Completed
Not Applicable
Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset SeizuresEpilepsies, PartialNCT00771927UCB Pharma1,005
Completed
Not Applicable
Long-term Safety and Tolerability of AFFITOPE AD02Alzheimer's DiseaseNCT00711321Affiris AG23
Completed
Not Applicable
Registry of Translarna (Ataluren) in Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)Muscular Dystrophy, DuchenneNCT02369731PTC Therapeutics316
Terminated
Not Applicable
Naloxegol Health Outcome Post Authorisation Safety StudyOpioid Induced ConstipationNCT02813369Kyowa Kirin Pharmaceutical Development Ltd10,000