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Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

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ClinicalTrials.gov Identifier: NCT02440022
Recruitment Status : Completed
First Posted : May 12, 2015
Results First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Combination Product: Lutonix DCB Device: Standard Balloon Angioplasty Catheter Procedure: Percutaneous Transluminal Angiography Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing Lutonix® 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae
Study Start Date : June 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Lutonix DCB
Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.
Combination Product: Lutonix DCB
Procedure: Percutaneous Transluminal Angiography
Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
Other Name: PTA

Active Comparator: Standard Balloon Angioplasty Catheter
Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Device: Standard Balloon Angioplasty Catheter
Procedure: Percutaneous Transluminal Angiography
Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
Other Name: PTA




Primary Outcome Measures :
  1. Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure [ Time Frame: 6 months post index procedure ]
    Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.

  2. Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure. [ Time Frame: 30 Days Post Index Procedure ]
    The primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit (CEC adjudicated).


Secondary Outcome Measures :
  1. Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months [ Time Frame: 3, 9, 12, 18, and 24 Months Post Index Procedure ]
    Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.

  2. Percentage of Participants With Device, Procedural and Clinical Success [ Time Frame: Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure ]
    • Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure.
    • Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs).
    • Clinical Success: The resumption of dialysis for at least one session after the index procedure.

  3. Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure [ Time Frame: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure ]
    Index access site abandonment refers to an abandonment due to either receiving a kidney transplant, converting to Peritoneal Dialysis, or a new access site being created.

  4. Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure [ Time Frame: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure ]
  5. Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) [ Time Frame: 1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure ]
    Events adjudicated as 'definitely related' and 'possibly related' by the CEC were combined in all analyses and are displayed as 'related' in this report.

  6. Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure [ Time Frame: 6 Months Post Index Procedure ]
    Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.

  7. Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure [ Time Frame: 3, 6, 9, 12, 18, and 24 Months Post Index Procedure ]
  8. Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure [ Time Frame: 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure ]


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
Criteria

Inclusion Criteria:

  1. Age ≥21 years;
  2. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF);
  3. Arteriovenous fistula located in the arm;
  4. Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions;
  5. Venous stenosis of an AV fistula with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.;
  6. Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon;
  7. Intended target lesion.

Exclusion Criteria:

  1. Women who are pregnant, lactating, or planning on becoming pregnant during the study;
  2. Hemodialysis access is located in the leg;
  3. Subject has more than two lesions in the access circuit;
  4. Subject has a secondary non-target lesion that cannot be successfully treated;
  5. Target lesion is located central to the axillosubclavian junction;
  6. The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);
  7. A thrombosed access;
  8. Surgical revision of the access site planned;
  9. Recent prior surgical interventions of the access site;
  10. Other planned treatment during the index procedure;
  11. Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;
  12. Known contraindication (including allergic reaction) or sensitivity to paclitaxel.
  13. Subjects who are taking immunosuppressive therapy or are routinely taking

    ≥10mg of prednisone per day;

  14. Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation;
  15. Subject has a life expectancy <12 months;
  16. Anticipated for a kidney transplant;
  17. Anticipated conversion to peritoneal dialysis;
  18. Subject has a stent located in the target or secondary non target lesion;
  19. Subject has an infected AV access or systemic infection;
  20. Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.

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): NCT02440022


Locations
Show Show 23 study locations
Sponsors and Collaborators
C. R. Bard
Investigators
Layout table for investigator information
Principal Investigator: Scott Trerotola, MD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by C. R. Bard:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02440022    
Other Study ID Numbers: CL0023-01
First Posted: May 12, 2015    Key Record Dates
Results First Posted: May 6, 2020
Last Update Posted: May 6, 2020
Last Verified: April 2020
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