End-Stage Renal DiseaseNCT03552289
Cook Enforcer Post-Market Study
A study testing Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and Conventional angioplasty balloon catheters in people with End-Stage Renal Disease, run by Cook Research Incorporated at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional angioplasty balloon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and Conventional angioplasty balloon catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Aug 2018to 27 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Clinical or physiological abnormalities which indicate dialysis access dysfunction (e.g., decreased access blood flow, elevated venous pressure, decreased dialysis dose, abnormal physical exam)
Who cannot join
- Less than 18 years old
- Pregnant, lactating, or planning to become pregnant in the 3 months following enrollment
- Underwent any surgical or interventional procedure of the access circuit less than or equal to 30 days prior to enrollment
- Scheduled for a kidney transplant
- Stent or stent graft in the arteriovenous (AV) dialysis access circuit
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Vascular Experts
Darien, Connecticut, 06820
Delaware Kidney/Nephrology Associates, PA
Newark, Delaware, 19713
Arizona Kideny Disease & Hypertension Surgery Center
Phoenix, Arizona, 85012
Fairlawn Surgery Center
Roanoke, Virginia, 24014
Vascular Institute of Virginia
Woodbridge, Virginia, 22193
About this study
Official title: Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis
The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional angioplasty balloon.
- Conditions
- End-Stage Renal Disease
- Being tested
- Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, Conventional angioplasty balloon catheters
- Keywords
- Dialysis, Renal, Hemodialysis, Stenosis(es), Transluminal, Percutaneous Transluminal Angioplasty
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon CatheterDevice
The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
Conventional angioplasty balloon cathetersDevice
Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
| Study group | Role | What they receive |
|---|---|---|
| Cook Enforcer balloon catheter | Active comparator | The Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. Receives: Device: Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
| Conventional angioplasty balloon catheters | Active comparator | Commercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. Receives: Device: Conventional angioplasty balloon catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Lesions Requiring Adjunctive Treatment
Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon
Measured: Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start7 Aug 2018
- Primary completion29 May 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552289
- Sponsor's protocol ID
- 17-04
- Status last verified
- Sep 2020
- First submitted
- 17 May 2018
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis
- ClinicalTrials.gov ID
- NCT03552289
- Acronym / sponsor ID
- 17-04
- Conditions
- End-Stage Renal Disease
- Keywords
- Dialysis, Renal, Hemodialysis, Stenosis(es), Transluminal, Percutaneous Transluminal Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Posted 24 Aug 2020
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 performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional angioplasty balloon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cook Enforcer balloon catheter | Active comparator | Device: Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon CatheterThe Enforcer balloon will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. |
| Conventional angioplasty balloon catheters | Active comparator | Device: Conventional angioplasty balloon cathetersCommercially available angioplasty balloon devices will be used in the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical or physiological abnormalities which indicate dialysis access dysfunction (e.g., decreased access blood flow, elevated venous pressure, decreased dialysis dose, abnormal physical exam)
Key exclusion criteria (5 listed)
- Less than 18 years old
- Pregnant, lactating, or planning to become pregnant in the 3 months following enrollment
- Underwent any surgical or interventional procedure of the access circuit less than or equal to 30 days prior to enrollment
- Scheduled for a kidney transplant
- Stent or stent graft in the arteriovenous (AV) dialysis access circuit
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 |
|---|---|---|
| Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon CatheterThe Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula | Device | Cook Enforcer balloon catheter |
| Conventional angioplasty balloon cathetersCommercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula | Device | Conventional angioplasty balloon catheters |
Primary outcome
Percent of Lesions Requiring Adjunctive Treatment
Time frame: Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour
Percentage of lesions requiring adjunctive treatment immediately following the initial treatment with the Enforcer or conventional angioplasty balloon
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and Conventional angioplasty balloon catheters in people with End-Stage Renal Disease, run by Cook Research Incorporated at 5 sites in United States.
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 1 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Lesions Requiring Adjunctive Treatment (time frame: Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour). 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 19 Oct 2020.