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

February 1, 2016 updated by: C. R. Bard

A Prospective, MultiCenter, Single-arm, Post-market Study of Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)

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.

Study Overview

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Graz, Austria, 8036
        • LKH-Univ. Klinikum Graz
      • Klagenfurt, Austria, 9020
        • Klinikum Klagenfurt am Wörthersee
      • Koln, Germany, 50937
        • Universitätsklinikum Köln AöR
      • Lubeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lutonix Paclitaxel Drug Coated Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Primary Patency (TLPP)
Time Frame: 12 months
12 months
Access circuit primary patency
Time Frame: 6 and 12 months
6 and 12 months
Abandonment of permanent access in the index extremity
Time Frame: 6 and 12 months
6 and 12 months
Number of interventions required to maintain target lesion patency
Time Frame: 6 and 12 months
6 and 12 months
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 and 12 months
Major vascular complications
Time Frame: < or at 1 month
< or at 1 month
Rate of device and procedure related adverse events
Time Frame: 1, 6 and 12 months
1, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (ESTIMATE)

July 8, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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