StenosisNCT00543348
RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
A study testing CUTTING BALLOON ANGIOPLASTY and Balloon angioplasty in people with Stenosis, run by Henry Ford Health System at 1 site in United States.
Trial summary
The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas. 2. SPECIFIC AIMS Study endpoints will be: Primary Endpoint 1. Primary and assisted patency at 6 months Secondary Endpoints: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stenosis
- What is being tested?
- CUTTING BALLOON ANGIOPLASTY and Balloon angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2008
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters
Who cannot join
- Arteriovenous prosthetic grafts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas.
- SPECIFIC AIMS
Study endpoints will be:
Primary Endpoint
- Primary and assisted patency at 6 months
Secondary Endpoints:
- Procedure effectiveness/residual stenosis
- Procedure-related complications
- Primary patency and primary assisted patency 12 months
- Secondary patency at 6 and 12 months
- Number/type of secondary interventions.
- Conditions
- Stenosis
- Being tested
- CUTTING BALLOON ANGIOPLASTY, Balloon angioplasty
- Keywords
- BALLOON ANGIOPLASTY, AUTOGENOUS FISTULA
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUTTING BALLOON ANGIOPLASTYProcedure or surgery
CUTTING BALLOON
Balloon angioplastyProcedure or surgery
HIGH PRESSURE BALLOON
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CUTTING BALLOON ANGIOPLASTY Receives: Procedure: CUTTING BALLOON ANGIOPLASTY |
| 2 | Placebo comparator | Balloon angioplasty with a high pressure balloon Receives: Procedure: CUTTING BALLOON ANGIOPLASTY; Procedure: Balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary and assisted patency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2008 (estimated)
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosisStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, loay kabbani, MD, Henry Ford Health System
- Investigators
- GEORGES HADDAD, MD, FACS, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543348
- Sponsor's protocol ID
- HFHIRB4244
- Status last verified
- Mar 2022
- First submitted
- 11 Oct 2007
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
- ClinicalTrials.gov ID
- NCT00543348
- Acronym / sponsor ID
- HFHIRB4244
- Conditions
- Stenosis
- Keywords
- BALLOON ANGIOPLASTY, AUTOGENOUS FISTULA
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Mar 2008 (estimated)
- First posted
- 12 Oct 2007 (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 proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas.
- SPECIFIC AIMS
Study endpoints will be:
Primary Endpoint
- Primary and assisted patency at 6 months
Secondary Endpoints:
- Procedure effectiveness/residual stenosis
- Procedure-related complications
- Primary patency and primary assisted patency 12 months
- Secondary patency at 6 and 12 months
- Number/type of secondary interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: CUTTING BALLOON ANGIOPLASTYCUTTING BALLOON ANGIOPLASTY |
| 2 | Placebo comparator | Procedure: CUTTING BALLOON ANGIOPLASTY, Procedure: Balloon angioplastyBalloon angioplasty with a high pressure balloon |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters
Key exclusion criteria (1 listed)
- Arteriovenous prosthetic grafts
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 |
|---|---|---|
| CUTTING BALLOON ANGIOPLASTYCUTTING BALLOON | Procedure or surgery | 1, 2 |
| Balloon angioplastyHIGH PRESSURE BALLOON | Procedure or surgery | 2 |
Primary outcome
Primary and assisted patency
Time frame: 6 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 21 Mar 2022.
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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.
GEORGES HADDAD, MD, FACS principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CUTTING BALLOON ANGIOPLASTY and Balloon angioplasty in people with Stenosis, run by Henry Ford Health System at 1 site 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 1 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 21 Mar 2022. 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 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. Some participants in this study may receive a placebo. 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?
Primary and assisted 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 21 Mar 2022.