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Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)

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. Identifier: NCT02183194
Recruitment Status : Withdrawn (Slow recruitment)
First Posted : July 8, 2014
Last Update Posted : February 2, 2016
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.

Condition or disease Intervention/treatment Phase
Dysfunctional AV Graft Dysfunctional AV Fistula Device: Lutonix Paclitaxel Drug Coated Balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, MultiCenter, Single-arm, Post-market Study of Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Lutonix Paclitaxel Drug Coated Balloon Device: Lutonix Paclitaxel Drug Coated Balloon

Primary Outcome Measures :
  1. Efficacy: Primary Patency [ Time Frame: 6 months ]
    Target Lesion Primary Patency (TLPP): The interval following index procedure intervention until the next reintervention of the target lesion or access thrombosis.

Secondary Outcome Measures :
  1. Target Lesion Primary Patency (TLPP) [ Time Frame: 12 months ]
  2. Access circuit primary patency [ Time Frame: 6 and 12 months ]
  3. Abandonment of permanent access in the index extremity [ Time Frame: 6 and 12 months ]
  4. Number of interventions required to maintain target lesion patency [ Time Frame: 6 and 12 months ]
  5. Number of interventions, required to maintain access circuit patency [ Time Frame: 6 and 12 months ]
    The access circuit is defined as "the area from the AV access graft arterial anastomosis to the superior vena-cava right atrial junction." The outcome is recording all interventions that occur in the access circuit up until the time of circuit failure (patency).

  6. Major vascular complications [ Time Frame: < or at 1 month ]
  7. Rate of device and procedure related adverse events [ Time Frame: 1, 6 and 12 months ]

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

Inclusion Criteria:

  1. Age ≥18 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. Hemodialysis access on the arm presenting with any clinical abnormalities as defined in the K/DOQI guidelines
  4. Native AV fistula or synthetic AV graft has been implanted ≥30 days
  5. Target de novo or non-stented restenotic lesion(s) consisting of a >50% stenosis by visual estimate. Successful treatment of non target lesion(s) (residual stenosis <30% by visual estimate) without procedural complication by standard of care
  6. Successful predilatation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon
  7. Intended target lesion(s) (maximum of 2) can be treated
  8. No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the treatment

Exclusion Criteria:

  1. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
  2. Known contraindication (including allergic reaction) or sensitivity to contrast media, ASA, clopidogrel, ticlopidine, paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication
  3. Life expectancy <12months
  4. Scheduled for kidney transplant or peritoneal dialysis in the next 12months;
  5. Thrombosed access
  6. Stent in the target treatment area
  7. Blood coagulative disorder, sepsis, or current AV access infection
  8. Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study NOTE: Enrollment in another investigational drug, biologic, or device study during the follow- up period is not allowed

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 identifier (NCT number): NCT02183194

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LKH-Univ. Klinikum Graz
Graz, Austria, 8036
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria, 9020
Universitätsklinikum Köln AöR
Koln, Germany, 50937
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lubeck, Germany, 23538
Sponsors and Collaborators
C. R. Bard

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Responsible Party: C. R. Bard Identifier: NCT02183194    
Other Study ID Numbers: CL0021-01
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action