IN.PACT™ AV Access Post-Approval Study (PAS002)

Arteriovenous Fistula Clinical Trial

Official title:

IN.PACT™ AV Access Post-Approval Study (PAS002)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04543539
• Other study ID #: IN.PACT™ AV Access PAS002
• Status: Recruiting
• Start date: November 13, 2020
• Est. completion date: February 2029

Study information

• Verified date: February 2024
• Source: Medtronic
• Contact: PSR Study Team
• Phone: 763-526-5668
• Email: rs.productsurveillanceregistry[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Long-term safety will be summarized

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 2029
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Occlusion
• Arteriovenous Fistula Stenosis
• Fistula

Intervention

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 Drug Coated Balloon (DCB) - Extended Cohort
For treatment of stenosis in the AV circuit

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	University of Michigan Health System - University Hospital	Ann Arbor	Michigan
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	University of Iowa	Iowa City	Iowa
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Cedars-Sinai Heart Institute	Los Angeles	California
United States	University of Wisconsin-Madison - Meriter Hospital	Madison	Wisconsin
United States	NCH Healthcare System	Naples	Florida
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	The Mount Sinai Hospital	New York	New York
United States	MUSC Health Dialysis Access Institute	Orangeburg	South Carolina
United States	Coastal Vascular and Interventional	Pensacola	Florida
United States	FirstHealth of the Carolinas	Pinehurst	North Carolina
United States	Oregon Health & Science University Hospital	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Stanford University Medical Center	Stanford	California
United States	Staten Island University Hospital	Staten Island	New York
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Medstar Washington Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Extended Cohort - Characterize Infections and Infestations Serious Adverse Events	Characterize infections and infestations Serious Adverse Events, including pneumonia.	Through 1-year and all-cause mortality through 5-years post-index procedure
Primary	Infection and Infestations Serious Adverse Events	Demonstrate Infection and Infestations Serious Adverse Events, including pneumonia, meets the performance goal of 30% in the primary cohort.	Through 12 months post-index procedure
Secondary	Mortality Rate	Determine mortality rate	Through 1, 2, 3, 4, and 5 years post-index procedure