Dysfunctional AV GraftACCESSNCT02183194
Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts
A study testing Lutonix Paclitaxel Drug Coated Balloon in people with Dysfunctional AV Graft and Dysfunctional AV Fistula, run by C. R. Bard at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysfunctional AV Graft, Dysfunctional AV Fistula
- What is being tested?
- Lutonix Paclitaxel Drug Coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Austria2 sites
LKH-Univ. Klinikum Graz
Graz, 8036
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Germany2 sites
Universitätsklinikum Köln AöR
Cologne, 50937
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, 23538
About this study
Official title: 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.
- Conditions
- Dysfunctional AV Graft, Dysfunctional AV Fistula
- Being tested
- Lutonix Paclitaxel Drug Coated Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutonix Paclitaxel Drug Coated BalloonDevice
| Study group | Role | What they receive |
|---|---|---|
| Lutonix Paclitaxel Drug Coated Balloon | Experimental | Not described Receives: Device: Lutonix Paclitaxel Drug Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
Target Lesion Primary Patency (TLPP)
Measured: 12 months
Access circuit primary patency
Measured: 6 and 12 months
Abandonment of permanent access in the index extremity
Measured: 6 and 12 months
Number of interventions required to maintain target lesion patency
Measured: 6 and 12 months
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).
Measured: 6 and 12 months
Major vascular complications
Measured: < or at 1 month
Rate of device and procedure related adverse events
Measured: 1, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional AV GraftStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183194
- Sponsor's protocol ID
- CL0021-01
- Acronym
- ACCESS
- Status last verified
- Feb 2016
- First submitted
- 25 Jun 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, MultiCenter, Single-arm, Post-market Study of Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)
- ClinicalTrials.gov ID
- NCT02183194
- Acronym / sponsor ID
- ACCESS / CL0021-01
- Conditions
- Dysfunctional AV Graft, Dysfunctional AV Fistula
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutonix Paclitaxel Drug Coated Balloon | Experimental | Device: Lutonix Paclitaxel Drug Coated Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutonix Paclitaxel Drug Coated Balloon | Device | Lutonix Paclitaxel Drug Coated Balloon |
Primary outcome
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.
7 secondary outcomes
Target Lesion Primary Patency (TLPP)
Time frame: 12 months
Access circuit primary patency
Time frame: 6 and 12 months
Abandonment of permanent access in the index extremity
Time frame: 6 and 12 months
Number of interventions required to maintain target lesion patency
Time frame: 6 and 12 months
Number of interventions, required to maintain access circuit patency
Time frame: 6 and 12 months
Major vascular complications
Time frame: < or at 1 month
Rate of device and procedure related adverse events
Time frame: 1, 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutonix Paclitaxel Drug Coated Balloon in people with Dysfunctional AV Graft and Dysfunctional AV Fistula, run by C. R. Bard at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Primary Patency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.