StenosesNCT00678249

Pivotal Study for the FLAIR Endovascular Stent Graft

A study testing FLAIR Endovascular Stent Graft and PTA in people with Stenoses, run by C. R. Bard at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Stenoses
What is being tested?: FLAIR Endovascular Stent Graft and PTA
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 227 participants
Where: 1 siteUnited States
Study dates: Jan 2001to Jun 2004
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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients between 18 to 90 years of age whose hemodialysis access was a synthetic AV access graft located in an arm.
Angiographic evidence of one or more stenoses, 7 cm or less in length and greater than or equal to 50%, at the graft-vein anastomosis of a synthetic AV access graft. The entire lesion must have been located within 7 cm of the anastomosis such that approximately 1 cm of the IMPRA/Bard Device must have extended into non-diseased vein and approximately 1 cm, but no more than 2 cm, of the IMPRA/Bard Device will be extended into non-diseased AV graft.
Clinical evidence of a hemodynamically significant stenosis.
Percutaneous endovascular therapy for the identified lesion was the best treatment choice in the opinion of the investigator.
Patients must have been able to understand and provide informed consent.
Patients whose synthetic AV access grafts had been implanted greater than 30 days and had undergone 1 or more successful hemodialysis sessions.
During primary balloon angioplasty, full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, must have been achieved.

Who cannot join

Concomitant disease (e.g., terminal cancer) or other medical condition that was likely to result in death of the patient within 6 months of the time of implantation.
Stenoses that had a corresponding thrombosis treated within 7 days.
The presence of a second lesion in the access circuit less than or equal to 3 cm from the edges of the primary lesion that was treated within 30 days or that was greater than or equal to 30%. Access circuit was defined as the area from the AV access graft arterial anastomosis to the superior vena cava-right atrial junction.
The presence of a second lesion in the access circuit greater than 3 cm from the edges of the primary lesion that was greater than or equal to 30%. Second lesions that were greater than or equal to 30% must have been treated prior to patient inclusion to reduce the percent stenosis to less than 30%.
Patients who were unwilling or unable to return for follow-up visits or patients with whom follow-up visits may have been unreliable.
Patients who had a stent placed at the target lesion site.

Show all 14Show fewer

Patients with a blood coagulative disorder or sepsis.
Patients in which the IMPRA/Bard Device would have been required to cross an angle (between the inflow vein and synthetic AV access graft) that was greater than 90 degrees.
Patients in which the IMPRA/Bard Device would have been required to be deployed fully across the elbow joint, which is identified radiographically by a combination of the humeroulnar joint and the humeroradial joint.
Patients with a contraindication to the use of contrast media.
Patients whose AV access graft was infected.
Patients who were currently or were scheduled to enroll in other investigations that conflicted with follow-up testing or confounds data in this trial.
Procedural use of another investigational device.
Patients who were pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York Presbyterian Hospital/Columbia
New York, New York, 10032

Other trials in United States

About this study

Official title: A Prospective, Multi-Center, Randomized Evaluation of an IMPRA/Bard ePTFE Encapsulated Carbon Lined Nitinol Endoluminal Device for AV Access Graft Stenoses

This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.

Read the detailed description

A total of 227 patients were treated at 16 U.S. investigational sites to evaluate the safety and effectiveness of the FLAIR™ Endovascular Stent Graft. This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.

Conditions: Stenoses
Being tested: FLAIR Endovascular Stent Graft, PTA
Keywords: Hemodialysis, Vascular Prosthesis, stenoses, grafts
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
Also called Flair, Stent Graft
Primary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft
PTAProcedure or surgery
Also called Flair, Stent Graft
Percutaneous Transluminal Angioplasty
FLAIR Endovascular Stent GraftDevice
Also called Flair, Stent Graft
Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.

Study groups in NCT00678249
Study group	Role	What they receive
FLAIR	Experimental	Primary PTA followed by placement of the FLAIR Endovascular Stent Graft Receives: Device: FLAIR Endovascular Stent Graft
PTA Only	Active comparator	Percutaneous Transluminal Angioplasty Receives: Procedure: PTA
FLAIR Roll-in Participants	Experimental	Primary Patency followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized. Receives: Device: FLAIR Endovascular Stent Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Participants With Treatment Area Primary Patency (TAPP)
TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.
Measured: 6 month follow-up

Secondary outcomes (8)

Total Number of Adverse Events
The safety endpoint was evaluated based on the incidence of adverse events observed within the same time interval. An adverse event was defined as any undesirable clinical occurrence in a patient that (a) is considered possibly or definietly device related by the investigator, (b) involves the access circuit (AV graft arterial anastomosis to the superior vena cava-right atrial junction) or the arm where the access circuit is located or (c) the investigator considers relevant to the objectives of this study. An adverse event could be mild, moderate or severe.
Measured: 6 month Follow-Up
Percent of Participants With Successful Delivery of the Device
The ability to successfully deliver the FLAIR™ Endovascular Stent Graft. Successful delivery is the ability to deliver and seat the implant in the intended location of a stenosed segment of the venous anastomosis region of a synthetic access graft. This attribute is only applicable to the FLAIR and FLAIR Roll-in arms.
Measured: Index Procedure
Percent of Participants With Procedural Success
Procedural Success was defined as anatomic success (<30% residual stenosis) and at least one indicator of hemodynamic or clinical success
Measured: Index Procedure
Percent of Participants With TAPP
TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.
Measured: 2 month Follow-Up
Percent of Participants With Access Circuit Primary Patency (ACPP)
ACCP defined as patency (open to blood flow) following the index study procedure until access thrombosis or an intervention of a lesion anywhere within the access circuit.
Measured: 6 month Follow-Up
Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)
ACAPP defined as patency (open to blood flow)following the index study procedure until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit.
Measured: 6 month Follow-Up
Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)
ACCP defined as patency (open to blood flow) following the index study procedure until the access is surgically revised or abandoned because of the inability to treat the original lesion. Multiple treatments for occlusions to restore patency are compatible with ACCP.
Measured: 6 month Follow-Up
Percent of Participants With Binary Restenosis
Binary restenosis defined as lesions with greater than or equal to 50% diameter stenosis of the treatment area (calculated by a core lab).
Measured: 6 month Follow-Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2001Jun 2004

First posted15 May 2008 (estimated)
Study startJan 2001
Primary completionJun 2004
Study completionJun 2004

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StenosesStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 227 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00678249
Sponsor's protocol ID: IMP-9809
Other IDs: P060002
Status last verified: May 2011
First submitted: 13 May 2008
Last updated: 11 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Haskal ZJ, Trerotola S, Dolmatch B, Schuman E, Altman S, Mietling S, Berman S, McLennan G, Trimmer C, Ross J, Vesely T. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010 Feb 11;362(6):494-503. doi: 10.1056/NEJMoa0902045.
PubMed 20147715

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stenoses trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center, Randomized Evaluation of an IMPRA/Bard ePTFE Encapsulated Carbon Lined Nitinol Endoluminal Device for AV Access Graft Stenoses
ClinicalTrials.gov ID: NCT00678249
Acronym / sponsor ID: IMP-9809
Conditions: Stenoses
Keywords: Hemodialysis, Vascular Prosthesis, stenoses, grafts
Study type: Interventional
Recruitment status: Completed
Enrolment: 227 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Jan 2001
Primary completion: Jun 2004 (actual)
Study completion: Jun 2004 (actual)
First posted: 15 May 2008 (estimated)
Results: Posted 9 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
FLAIR	Experimental	Device: FLAIR Endovascular Stent GraftPrimary PTA followed by placement of the FLAIR Endovascular Stent Graft
PTA Only	Active comparator	Procedure: PTAPercutaneous Transluminal Angioplasty
FLAIR Roll-in Participants	Experimental	Device: FLAIR Endovascular Stent GraftPrimary Patency followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female patients between 18 to 90 years of age whose hemodialysis access was a synthetic AV access graft located in an arm.
Angiographic evidence of one or more stenoses, 7 cm or less in length and greater than or equal to 50%, at the graft-vein anastomosis of a synthetic AV access graft. The entire lesion must have been located within 7 cm of the anastomosis such that approximately 1 cm of the IMPRA/Bard Device must have extended into non-diseased vein and approximately 1 cm, but no more than 2 cm, of the IMPRA/Bard Device will be extended into non-diseased AV graft.
Clinical evidence of a hemodynamically significant stenosis.
Percutaneous endovascular therapy for the identified lesion was the best treatment choice in the opinion of the investigator.
Patients must have been able to understand and provide informed consent.

Key exclusion criteria (14 listed)

Concomitant disease (e.g., terminal cancer) or other medical condition that was likely to result in death of the patient within 6 months of the time of implantation.
Stenoses that had a corresponding thrombosis treated within 7 days.
The presence of a second lesion in the access circuit less than or equal to 3 cm from the edges of the primary lesion that was treated within 30 days or that was greater than or equal to 30%. Access circuit was defined as the area from the AV access graft arterial anastomosis to the superior vena cava-right atrial junction.
The presence of a second lesion in the access circuit greater than 3 cm from the edges of the primary lesion that was greater than or equal to 30%. Second lesions that were greater than or equal to 30% must have been treated prior to patient inclusion to reduce the percent stenosis to less than 30%.
Patients who were unwilling or unable to return for follow-up visits or patients with whom follow-up visits may have been unreliable.

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 GraftAlso: Flair, Stent GraftPrimary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft	Device	FLAIR
PTAAlso: Flair, Stent GraftPercutaneous Transluminal Angioplasty	Procedure or surgery	PTA Only
FLAIR Endovascular Stent GraftAlso: Flair, Stent GraftPrimary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.	Device	FLAIR Roll-in Participants

Primary outcome

Percent of Participants With Treatment Area Primary Patency (TAPP)
Time frame: 6 month follow-up
TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.

8 secondary outcomes

Total Number of Adverse Events
Time frame: 6 month Follow-Up
Percent of Participants With Successful Delivery of the Device
Time frame: Index Procedure
Percent of Participants With Procedural Success
Time frame: Index Procedure
Percent of Participants With TAPP
Time frame: 2 month Follow-Up
Percent of Participants With Access Circuit Primary Patency (ACPP)
Time frame: 6 month Follow-Up
Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)
Time frame: 6 month Follow-Up
Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)
Time frame: 6 month Follow-Up
Percent of Participants With Binary Restenosis
Time frame: 6 month Follow-Up

Results and safety

Results posted to the registry on 9 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FLAIR	97	97
PTA Only	93	93
FLAIR Roll-In Participants	37	37

Primary outcome: Percent of Participants With Treatment Area Primary Patency (TAPP)

Time frame: 6 month follow-up. Number. Unit: Percentage of Participants

Measure	FLAIR n = 91	PTA Only n = 86	FLAIR Roll-In Participants n = 35
Value	51	23	60

FLAIR vs PTA Only: p <0.001, Regression, Logistic

Population analysed: If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FLAIR	5 of 97 (5.2%)	67 of 97 (69.1%)	Not reported
PTA Only	5 of 93 (5.4%)	80 of 93 (86%)	Not reported
FLAIR Roll-In Participants	1 of 37 (2.7%)	26 of 37 (70.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20147715Haskal ZJ, Trerotola S, Dolmatch B, Schuman E, Altman S, Mietling S, Berman S, McLennan G, Trimmer C, Ross J, Vesely T. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010 Feb 11;362(6):494-503. doi: 10.1056/NEJMoa0902045.

Related trials for Stenoses

Active, not recruiting
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Acute Pain
Active, not recruitingObservational study
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Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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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.

David Ciavarella, MD study director

C. R. Bard

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 and PTA in people with Stenoses, 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 7 inclusion and 14 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 11 May 2011. 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 9 May 2011). 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 Participants With Treatment Area Primary Patency (TAPP) (time frame: 6 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00678249, which also lists 1 linked publication.

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 11 May 2011.