- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183194
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
Status
Withdrawn
Conditions
Intervention / Treatment
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.
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:
- Age ≥18 years
- 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)
- Hemodialysis access on the arm presenting with any clinical abnormalities as defined in the K/DOQI guidelines
- Native AV fistula or synthetic AV graft has been implanted ≥30 days
- 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
- Successful predilatation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon
- Intended target lesion(s) (maximum of 2) can be treated
- No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the treatment
Exclusion Criteria:
- Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children
- 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
- Life expectancy <12months
- Scheduled for kidney transplant or peritoneal dialysis in the next 12months;
- Thrombosed access
- Stent in the target treatment area
- Blood coagulative disorder, sepsis, or current AV access infection
- 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
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Congenital Abnormalities
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Fistula
- Arteriovenous Fistula
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- CL0021-01
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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