Renal FailurePhase 2NCT01001676
Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis
A Phase 2 study testing Percutaneous Transluminal Angioplasty (PTA) and Paclitaxel Eluting Balloon Angioplasty in people with Renal Failure, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Introduction: Narrowing of the draining vein occurs in >50% of hemodialysis fistula and left untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in the vessel wall (intimal hyperplasia). The standard treatment is balloon dilatation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Percutaneous Transluminal Angioplasty (PTA) and Paclitaxel Eluting Balloon Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Jul 2014
- Phase
- Phase 2
- 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
- Hemodialysis access located in the forearm or upper arm
- Patient with clinical or hemodynamic evidence of graft dysfunction
- Hemodialysis access is > 3 months old
Who cannot join
- Intervention of the vascular access circuit within the past 30 days
- Thrombosed/clotted access
- Evidence of systemic infection or a local infection associated with the graft
- Positive pregnancy test within 7 days before enrolment
- Patient is scheduled for a kidney transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access
Introduction: Narrowing of the draining vein occurs in >50% of hemodialysis fistula and left untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in the vessel wall (intimal hyperplasia). The standard treatment is balloon dilatation. However, narrowing will inevitably recur in 2-3 months hence requiring further dilatation. Intimal hyperplasia also occurs in the heart and leg circulation. The drug paclitaxel has been used with great success in preventing intimal hyperplasia in these vessels following balloon dilatation. Administer locally, paclitaxel inhibits excess tissue growth in the vessel wall. The investigators believe that this drug will have similar effect in hemodialysis access..
Objective: To assess the effect of paclitaxel in hemodialysis access with narrowing. Paclitaxel is delivered by a paclitaxel-coated balloon. This balloon dilates the narrow segment and simultaneously delivers paclitaxel to the vessel wall.
Read more
Methodology: Patients with narrowed hemodialysis access are dilated with the paclitaxel-coated balloon or conventional balloon in randomized manner. The patency of the two groups are evaluated and compared at 6 months follow-up.
Potential benefit: Decrease number of balloon dilatations and hence hospital admissions, improve dialysis fistula function, and decrease overall economic cost.
- Conditions
- Renal Failure
- Being tested
- Percutaneous Transluminal Angioplasty (PTA), Paclitaxel Eluting Balloon Angioplasty
- Keywords
- renal failure, Restenosis, Dialysis access, Paclitaxel, Angioplasty, Intimal hyperplasia
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Transluminal Angioplasty (PTA)Device
Angioplasty with the use of Conventional balloon
Paclitaxel Eluting Balloon AngioplastyDevice
Also called Passeo-18 Lux (Biotronik)
Angioplasty with the use of paclitaxel eluting balloon
| Study group | Role | What they receive |
|---|---|---|
| Conventional Balloon Angioplasty | Active comparator | Not described Receives: Device: Percutaneous Transluminal Angioplasty (PTA) |
| Drug Eluting Balloon Angioplasty | Experimental | Not described Receives: Device: Paclitaxel Eluting Balloon Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Measured: at 6 months
Secondary outcomes (1)
Transonic blood flows
Measured: monthly for up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startFeb 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kong Teng Tan, BCh MB, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001676
- Sponsor's protocol ID
- ktt1
- Status last verified
- Jan 2012
- First submitted
- 26 Oct 2009
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access
- ClinicalTrials.gov ID
- NCT01001676
- Acronym / sponsor ID
- ktt1
- Conditions
- Renal Failure
- Keywords
- renal failure, Restenosis, Dialysis access, Paclitaxel, Angioplasty, Intimal hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Oct 2009 (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.
Introduction: Narrowing of the draining vein occurs in >50% of hemodialysis fistula and left untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in the vessel wall (intimal hyperplasia). The standard treatment is balloon dilatation. However, narrowing will inevitably recur in 2-3 months hence requiring further dilatation. Intimal hyperplasia also occurs in the heart and leg circulation. The drug paclitaxel has been used with great success in preventing intimal hyperplasia in these vessels following balloon dilatation. Administer locally, paclitaxel inhibits excess tissue growth in the vessel wall. The investigators believe that this drug will have similar effect in hemodialysis access..
Objective: To assess the effect of paclitaxel in hemodialysis access with narrowing. Paclitaxel is delivered by a paclitaxel-coated balloon. This balloon dilates the narrow segment and simultaneously delivers paclitaxel to the vessel wall.
Methodology: Patients with narrowed hemodialysis access are dilated with the paclitaxel-coated balloon or conventional balloon in randomized manner. The patency of the two groups are evaluated and compared at 6 months follow-up.
Potential benefit: Decrease number of balloon dilatations and hence hospital admissions, improve dialysis fistula function, and decrease overall economic cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Balloon Angioplasty | Active comparator | Device: Percutaneous Transluminal Angioplasty (PTA) |
| Drug Eluting Balloon Angioplasty | Experimental | Device: Paclitaxel Eluting Balloon Angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hemodialysis access located in the forearm or upper arm
- Patient with clinical or hemodynamic evidence of graft dysfunction
- Hemodialysis access is > 3 months old
Key exclusion criteria (5 listed)
- Intervention of the vascular access circuit within the past 30 days
- Thrombosed/clotted access
- Evidence of systemic infection or a local infection associated with the graft
- Positive pregnancy test within 7 days before enrolment
- Patient is scheduled for a kidney transplant
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 |
|---|---|---|
| Percutaneous Transluminal Angioplasty (PTA)Angioplasty with the use of Conventional balloon | Device | Conventional Balloon Angioplasty |
| Paclitaxel Eluting Balloon AngioplastyAlso: Passeo-18 Lux (Biotronik)Angioplasty with the use of paclitaxel eluting balloon | Device | Drug Eluting Balloon Angioplasty |
Primary outcome
Primary patency
Time frame: at 6 months
1 secondary outcome
Transonic blood flows
Time frame: monthly for up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Kong Teng Tan, BCh MB principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Percutaneous Transluminal Angioplasty (PTA) and Paclitaxel Eluting Balloon Angioplasty in people with Renal Failure, run by University Health Network, Toronto at 1 site in Canada.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary patency (time frame: at 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 17 Nov 2014.