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Trial record 1 of 3 for:    IN.PACT AV
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IN.PACT™ AV Access Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041467
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity.

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Stenosis Arteriovenous Fistula Occlusion Arteriovenous Fistula Fistula Device: IN.PACT AV DCB Device: Standard Balloon Angioplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : December 6, 2018
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty Fistulas

Arm Intervention/treatment
Experimental: IN.PACT AV DCB
PTA will be performed using the IN.PACT AV Access Drug Coated Balloon. IN.PACT AV Access DCB was the device name used during the clinical study. Medtronic has changed the name of the device to IN.PACT™ AV Paclitaxel-Coated Balloon Catheter (also referred as IN.PACT AV DCB). Hence, throughout posting, the study device will be referred to as the "IN.PACT AV DCB."
Device: IN.PACT AV DCB
IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

Active Comparator: Standard Balloon Angioplasty
PTA will be performed using a commercially available uncoated PTA balloon.
Device: Standard Balloon Angioplasty
Standard PTA Balloon




Primary Outcome Measures :
  1. Number of Participants With Target Lesion Primary Patency Though 6 Months [ Time Frame: 6 Months Post-Procedure ]
    Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.

  2. Primary Safety Endpoint - Serious Adverse Event Rate [ Time Frame: 30 days post procedure ]
    Serious Adverse Event (SAE) rate involving the AV access circuit


Secondary Outcome Measures :
  1. Access Circuit Primary Patency [ Time Frame: 3, 6, 9, 12, 18, and 24 Months ]
    Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-procedure. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.

  2. Target Lesion Primary Patency [ Time Frame: 3, 9, 12, 18, and 24 Months ]
    Percent of subjects with freedom from clinical drive target lesion revascularization or access thrombosis occurring in the target lesion. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.

  3. Cumulative Target Lesion Revascularizations [ Time Frame: 3, 6, 9, 12, 18, and 24 Months ]
    The proportion of subjects with target lesion revascularizations. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.

  4. Total Number of Interventions Required to Maintain Target Lesion Patency [ Time Frame: 3, 6, 9, 12, 18, and 24 Months ]
    The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-procedure. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.

  5. Total Number of Interventions Required to Maintain Access Circuit Patency [ Time Frame: 3, 6, 9, 12, 18, and 24 Months ]
    The number of re-interventions in the target lesion and/or access circuit. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.

  6. Cumulative Access Circuit Thromboses [ Time Frame: 3, 6, 9, 12, 18, and 24 Months ]
    Proportion of subjects with access circuit thrombosis. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.

  7. Device Success [ Time Frame: Time of Procedure ]
    Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.

  8. Procedure Success [ Time Frame: Time of Procedure ]
    Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).

  9. Clinical Success [ Time Frame: From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure. ]
    Resumption of successful dialysis for at least one session after index procedure.

  10. Rate of Device Related Adverse Events [ Time Frame: 30 days, 3, 6, 9, 12, 18, and 24 Months. ]
    Device Related Adverse Event Rate: defined as proportion of subjects with device related Adverse Events. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.

  11. Procedure Related Adverse Event Rate [ Time Frame: 30 Days, 3, 6, 9, 12, 18, and 24 Months ]
    Procedure Related Adverse Event Rate: defined as proportion of subjects with procedure related Adverse Events reported post-index procedure until the first successful dialysis session. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Patient is ≥21 years of age.
  2. Patient has a life expectancy of ≥ 12 months
  3. Patient has a native AV fistula created ≥ 60 days prior to the index procedure
  4. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period
  5. Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis. Note: If the lesion is located in the anastomosis, the treatment may be delivered up to 2 cm upstream on the arterial end. If the lesion is located in the cephalic arch, the treatment may be delivered up to 2 cm into the subclavian vein
  6. Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be enrolled provided they meet all of the following criteria: Separated by a gap of ≤ 30mm (3 cm), total combined lesion length, including 30 mm gap, ≤ 100 mm, and able to be treated as a single lesion
  7. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate). Note: tandem lesions may be enrolled provided they meet all of the following criteria: Separated by a gap of ≤ 30 mm (3 cm), total combined lesion length, including 30 mm gap, is ≤ 100mm, and able to be treated as a single lesion
  8. Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a high pressure PTA balloon defined as: residual stenosis of ≤ 30% and absence of a flow limiting dissection (Grade ≥ C) or perforation
  9. Patient provides written consent prior to enrollment in the study
  10. Patient is willing to comply with all follow-up evaluations at specified times

Exclusion Criteria:

  1. Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
  2. Patient is receiving immunosuppressive therapy
  3. Patient is anticipating a kidney transplant within 6 months of enrollment into the study
  4. Patient has undergone prior intervention of access site within 30 days of index procedure
  5. Patient with anticipated conversion to peritoneal dialysis
  6. Patient has an infected AV access or systemic infection
  7. Patient has planned surgical revision of access site
  8. Patient with secondary non-target lesion requiring treatment within 30-days post index procedure
  9. Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
  10. Patient with target AVF or access circuit which previously had or currently has a thrombosis
  11. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
  12. Patient with target lesion located central to the axillosubclavian junction
  13. Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access
  14. Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site
  15. Patient has presence of a stent located in the target AV access circuit
  16. Patients with known allergies or sensitivities to paclitaxel
  17. Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated
  18. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
  19. Patient with clinically significant Steal Syndrome requiring treatment
  20. Patient is enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint, or was previously enrolled in this study
  21. Patient has a comorbid-condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol of confound 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): NCT03041467


Locations
Show Show 29 study locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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Principal Investigator: Robert Lookstein, MD The Mount Sinai Hospital
Principal Investigator: Andrew Holden, MD Auckland City Hospital
Principal Investigator: Hiroaki Haruguchi, MD Haruguchi Vascular Access Clinic
  Study Documents (Full-Text)

Documents provided by Medtronic Endovascular:
Statistical Analysis Plan  [PDF] December 13, 2018
Study Protocol  [PDF] April 26, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT03041467    
Other Study ID Numbers: APV-IN.PACT AV Access
First Posted: February 2, 2017    Key Record Dates
Results First Posted: February 27, 2020
Last Update Posted: February 27, 2020
Last Verified: February 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