Clinical trial NCT04543539: IN.PACT™ AV Access Post-Approval Study (PAS002)
Official title: IN.PACT™ AV Access Post-Approval Study (PAS002)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arteriovenous Fistula
Arteriovenous Fistula Stenosis
Arteriovenous Fistula Occlusion
Fistula
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.

Eligibility 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

Exclusion Criteria for Extended Cohort:

* Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19

Primary outcomes:
measure: Infection and Infestations Serious Adverse Events
timeFrame: Through 12 months post-index procedure
Secondary outcomes:
measure: Mortality Rate
timeFrame: Through 1, 2, 3, 4, and 5 years post-index procedure
Other outcomes:
measure: Extended Cohort - Characterize Infections and Infestations Serious Adverse Events
timeFrame: Through 1-year and all-cause mortality through 5-years post-index procedure
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Heart Institute
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington D.C.
country: United States
facility: Medstar Washington Hospital
state: District of Columbia
city: Naples
country: United States
facility: NCH Healthcare System
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan Health System - University Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University Hospital
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Orangeburg
country: United States
facility: MUSC Health Dialysis Access Institute
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison - Meriter Hospital
state: Wisconsin
Study officials:
References: