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Trial record 2 of 3 for:    IN.PACT AV

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04543539
Recruitment Status : Not yet recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief Summary:
Long-term safety will be summarized

Condition or disease Intervention/treatment
Arteriovenous Fistula Arteriovenous Fistula Stenosis Arteriovenous Fistula Occlusion Fistula Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: IN.PACT™ AV Access Post-Approval Study (PAS002)
Estimated Study Start Date : October 17, 2020
Estimated Primary Completion Date : October 17, 2025
Estimated Study Completion Date : October 17, 2027

Group/Cohort 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mortality Rate [ Time Frame: Through 1, 2, 3, 4, and 5 years post-index procedure ]
    Determine mortality rate


Other Outcome Measures:
  1. Extended Cohort - Characterize Infections and Infestations Serious Adverse Events [ Time Frame: Through 1-year and all-cause mortality through 5-years post-index procedure ]
    Characterize infections and infestations Serious Adverse Events, including pneumonia.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543539


Contacts
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Contact: PSR Study Team 763-526-5668 rs.productsurveillanceregistry@medtronic.com

Sponsors and Collaborators
Medtronic
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT04543539    
Other Study ID Numbers: IN.PACT™ AV Access PAS002
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities