Constriction, PathologicFLAIR DSNCT00614315
FLAIR™ Delivery System Study
A study testing FLAIR™ Endovascular Stent Graft in people with Constriction, Pathologic, run by C. R. Bard at 1 site in United States.
Trial summary
The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constriction, Pathologic
- What is being tested?
- FLAIR™ Endovascular Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Feb 2008
- 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
- The subject is either a male or non-pregnant female ≥ 18 years old.
- The subject has been properly informed about the study per IRB requirements, and has signed and dated the IRB-approved ICF.
- The subject is willing to comply with the protocol requirements and can be contacted by telephone.
- The subject has a synthetic AV access graft located in an arm that has been implanted for > 30 days and has undergone at least one successful dialysis session prior to the index procedure.
- Angiographic evidence indicates that the subject has a stenosis of >50% located at the graft-vein anastomosis of the subject's synthetic AV access graft.
- The target lesion is estimated to be ≤ 7 cm in length by angiography prior to performance of any interventional procedures.
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- The entire target lesion is located within 7 cm of the graft-vein anastomosis, as verified by angiography, such that approximately 1 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased vein and approximately 1 cm but no more than 2 cm of the FLAIR™ Endovascular Stent Graft will extend into non-diseased AV graft.
- Graft diameter at the deployment site is between 5 mm and 8 mm, as verified by angiography.
- Full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty.
Who cannot join
- The subject has a life expectancy of < 6 months.
- The presence of a previously placed stent and/or stent graft located in the treatment area. The treatment area is defined as the entire target lesion and 1 cm of landing zone into both non-diseased AV graft and non-diseased vein.
- The subject has an infected AV access graft or other infection.
- The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft be deployed fully across the elbow joint.
- The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft cross an angle (between the outflow vein and synthetic AV access graft) that is > 90 degrees.
- The subject has an uncorrected blood coagulation disorder.
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- The subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated.
- Subject is currently enrolled or scheduled to be enrolled in other investigations that conflict with follow-up testing or confounds data in this trial.
- The subject has a known hypersensitivity to nickel-titanium.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Image Guided Surgery
Fairfield, Connecticut, 06825
About this study
Official title: A Prospective Observational Study of the FLAIR™ Endovascular Stent Graft Optimized Delivery System
The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System.
- Conditions
- Constriction, Pathologic
- Being tested
- FLAIR™ Endovascular Stent Graft
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLAIR™ Endovascular Stent GraftDevice
The FLAIR™ Endovascular Stent Graft is designed to treat venous anastomotic stenoses of AV access grafts, providing both structural support of the site following angioplasty (stent), and a barrier to locally recurrent flow-limiting neointimal tissue growth (covering/graft).
| Study group | Role | What they receive |
|---|---|---|
| FLAIR Endovascular Stent Graft and Delivery System | Experimental | Not described Receives: Device: FLAIR™ Endovascular Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success for Delivery
defined as deployment of the implant to the intended location, assessed at the time of the index procedure.
Measured: Measured at the time of implantation (Day 0)
Secondary outcomes (1)
Number of Device/Procedure-related Adverse Events(Safety of Delivery)
Device/Procedure-related adverse events from the index procedure through 30 days post procedure
Measured: Index Procedure to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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 Constriction, PathologicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melvin Rosenblatt, M.D., Principal investigator, Connecticut Image Guided Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614315
- Sponsor's protocol ID
- BPV-07-001
- Acronym
- FLAIR DS
- Status last verified
- Jan 2017
- First submitted
- 18 Dec 2007
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of the FLAIR™ Endovascular Stent Graft Optimized Delivery System
- ClinicalTrials.gov ID
- NCT00614315
- Acronym / sponsor ID
- FLAIR DS / BPV-07-001
- Conditions
- Constriction, Pathologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 6 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLAIR Endovascular Stent Graft and Delivery System | Experimental | Device: FLAIR™ Endovascular Stent Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject is either a male or non-pregnant female ≥ 18 years old.
- The subject has been properly informed about the study per IRB requirements, and has signed and dated the IRB-approved ICF.
- The subject is willing to comply with the protocol requirements and can be contacted by telephone.
- The subject has a synthetic AV access graft located in an arm that has been implanted for > 30 days and has undergone at least one successful dialysis session prior to the index procedure.
- Angiographic evidence indicates that the subject has a stenosis of >50% located at the graft-vein anastomosis of the subject's synthetic AV access graft.
Key exclusion criteria (9 listed)
- The subject has a life expectancy of < 6 months.
- The presence of a previously placed stent and/or stent graft located in the treatment area. The treatment area is defined as the entire target lesion and 1 cm of landing zone into both non-diseased AV graft and non-diseased vein.
- The subject has an infected AV access graft or other infection.
- The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft be deployed fully across the elbow joint.
- The location of the target lesion would require that the FLAIR™ Endovascular Stent Graft cross an angle (between the outflow vein and synthetic AV access graft) that is > 90 degrees.
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 |
|---|---|---|
| FLAIR™ Endovascular Stent GraftThe FLAIR™ Endovascular Stent Graft is designed to treat venous anastomotic stenoses of AV access grafts, providing both structural support of the site following angioplasty (stent), and a barrier to locally recurrent flow-limiting neointimal tissue growth (covering/graft). | Device | FLAIR Endovascular Stent Graft and Delivery System |
Primary outcome
Technical Success for Delivery
Time frame: Measured at the time of implantation (Day 0)
defined as deployment of the implant to the intended location, assessed at the time of the index procedure.
1 secondary outcome
Number of Device/Procedure-related Adverse Events(Safety of Delivery)
Time frame: Index Procedure to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- 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.
Melvin Rosenblatt, M.D. principal investigator
Connecticut Image Guided Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLAIR™ Endovascular Stent Graft in people with Constriction, Pathologic, run by C. R. Bard 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 9 inclusion and 9 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 28 Feb 2017. 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. 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 6 Oct 2010). 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?
Technical Success for Delivery (time frame: Measured at the time of implantation (Day 0)). 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 28 Feb 2017.