Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)
Primary Purpose
Dysfunctional AV Graft, Dysfunctional AV Fistula
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lutonix Paclitaxel Drug Coated Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Dysfunctional AV Graft
Eligibility Criteria
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
Sites / Locations
- LKH-Univ. Klinikum Graz
- Klinikum Klagenfurt am Wörthersee
- Universitätsklinikum Köln AöR
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lutonix Paclitaxel Drug Coated Balloon
Arm Description
Outcomes
Primary Outcome Measures
Efficacy: Primary Patency
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
Target Lesion Primary Patency (TLPP)
Access circuit primary patency
Abandonment of permanent access in the index extremity
Number of interventions required to maintain target lesion patency
Number of interventions, required to maintain access circuit patency
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).
Major vascular complications
Rate of device and procedure related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02183194
Brief Title
Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts
Acronym
ACCESS
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Slow recruitment
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional AV Graft, Dysfunctional AV Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lutonix Paclitaxel Drug Coated Balloon
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Lutonix Paclitaxel Drug Coated Balloon
Primary Outcome Measure Information:
Title
Efficacy: Primary Patency
Description
Target Lesion Primary Patency (TLPP): The interval following index procedure intervention until the next reintervention of the target lesion or access thrombosis.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Target Lesion Primary Patency (TLPP)
Time Frame
12 months
Title
Access circuit primary patency
Time Frame
6 and 12 months
Title
Abandonment of permanent access in the index extremity
Time Frame
6 and 12 months
Title
Number of interventions required to maintain target lesion patency
Time Frame
6 and 12 months
Title
Number of interventions, required to maintain access circuit patency
Description
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).
Time Frame
6 and 12 months
Title
Major vascular complications
Time Frame
< or at 1 month
Title
Rate of device and procedure related adverse events
Time Frame
1, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
LKH-Univ. Klinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Universitätsklinikum Köln AöR
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts
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