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Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae (AVPAS)

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ClinicalTrials.gov Identifier: NCT03506308
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in 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 Device: LUTONIX 035 Drug Coated Balloon PTA Catheter Not Applicable

Detailed Description:
This post-market approval study (PAS) is required by the FDA as a condition of approval for the Lutonix drug coated balloon catheter. It is intended to demonstrate safety and assess the clinical use and outcomes of the LUTONIX Catheter in dysfunctional arteriovenous fistulae (AVF) in a heterogeneous patient population in real world clinical practice.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 213 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas Medicines

Arm Intervention/treatment
LUTONIX 035 Drug Coated Balloon PTA Catheter
This is a single-arm study. All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Device: LUTONIX 035 Drug Coated Balloon PTA Catheter
All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.




Primary Outcome Measures :
  1. Percentage of Participants With Target Lesion Primary Patency (TLPP) [ Time Frame: 6 Months ]
    TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.

  2. Percentage of Participants With No Primary Safety Events [ Time Frame: 30 days ]
    Primary safety events include any serious adverse event(s) involving the AV access circuit through 30 days


Secondary Outcome Measures :
  1. Percentage of Participants With Target Lesion Primary Patency [ Time Frame: 12, 18, 24 Months ]
    TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.

  2. Number of re-interventions required to maintain target lesion patency [ Time Frame: 6, 12, 18, 24 Months ]
    Clinically driven reintervention is defined as a lesion that has ≥ 50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines.

  3. Percentage of Participants With Access Circuit Primary Patency (ACPP) [ Time Frame: 6, 12, 18, 24 Months ]
    Access circuit is defined as the area from the AV access anastomosis to the superior vena cava-right atrial junction.

  4. Number of re-interventions required to maintain access circuit patency [ Time Frame: 6, 12, 18, 24 Months ]
    Clinically driven reintervention is defined as a lesion that has ≥ 50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines.

  5. Percentage of Participants With Device, Procedural, and Clinical Success [ Time Frame: 24 Months ]

    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.


  6. Percentage of Participants With Abandonment of Permanent Access in the Index Extremity [ Time Frame: 6, 12, 18, 24 Months ]
    The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.

  7. Percentage of Participants With Secondary Patency of the Access Circuit [ Time Frame: 6, 12, 18, 24 Months ]
    Survival of patency of access circuit from the time of intervention until access abandonment or achievement of a censored event (death, transfer to another hemodialysis unit, transfer to peritoneal dialysis, transplantation, and end of study period), and includes all surgical and endovascular interventions.

  8. Time to loss of target lesion secondary patency following DCB intervention [ Time Frame: 24 Months ]
    Time between first reintervention with the DCB to the next loss of patency

  9. Percentage of Participants With Freedom from any Serious Adverse Event(s) Involving the AV Access Circuit [ Time Frame: 6, 12, 18, 24 Months ]
    Safety events include any serious adverse event(s) involving the AV access circuit

  10. Percentage of Participants With Device and Procedure Related Adverse Events [ Time Frame: 6, 12, 18, 24 Months ]
    Freedom from device-related or procedure-related serious adverse events


Other Outcome Measures:
  1. Vital status of participants [ Time Frame: 36, 48, and 60 Months ]
    All cause death



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

Inclusion Criteria:

  1. Male or non-pregnant, non-breastfeeding female ≥18 years of age
  2. Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
  3. Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines
  4. Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
  5. Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein
  6. Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:

    1. No clinically significant dissection;
    2. No extravasation requiring treatment;
    3. Residual stenosis ≤30% by angiographic measurement;
    4. Ability to completely efface the waist using the pre-dilation balloon.

Exclusion Criteria:

  1. Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
  2. Subject has a non-controllable allergy to contrast
  3. Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up
  4. Target lesion is located central to the axillosubclavian junction
  5. A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
  6. Prior surgical interventions of the access site ≤30 days before the index procedure
  7. Target lesion is located within a bare metal or covered stent

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): NCT03506308


Contacts
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Contact: Kirti Sawant 737-414-3363 kirti.sawant@bd.com
Contact: Anna Lovas (763) 445-2385 anna.lovas@bd.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
C. R. Bard
Investigators
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Principal Investigator: Scott Trerotola, MD Hospital of the University of Pennsylvania; Division of Interventional Radiology
Principal Investigator: Dheeraj Rajan, MD University Health Network; Division of Vascular & Interventional Radiology
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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT03506308    
Other Study ID Numbers: CL0033-01
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
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
Product Manufactured in and Exported from the U.S.: 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