CompletedNCT00614315FLAIR DSUpdated Feb 28, 2017Results posted

FLAIR™ Delivery System Study

An interventional study of FLAIR™ Endovascular Stent Graft in Constriction, Pathologic, sponsored by C. R. Bard. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by C. R. Bard · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System.

Conditions studied

Constriction, Pathologic

Browse trials for

Constriction, Pathologic 1,117

In context

Constriction, Pathologic

1,117 studies on the registry are indexed under Constriction, Pathologic; 231 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 672 interventional studies indexed under Constriction, Pathologic.

Browse Constriction, Pathologic studies →

Lead sponsor

C. R. Bard is the lead sponsor of 113 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.
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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
FLAIR Endovascular Stent Graft and Delivery System
Device: FLAIR™ Endovascular Stent Graft

Interventions

DeviceFLAIR™ Endovascular Stent Graft
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).

What researchers measure

Primary outcomes

Technical Success for Delivery
defined as deployment of the implant to the intended location, assessed at the time of the index procedure.
Time frame: Measured at the time of implantation (Day 0)

Secondary outcomes

Number of Device/Procedure-related Adverse Events(Safety of Delivery)
Device/Procedure-related adverse events from the index procedure through 30 days post procedure
Time frame: Index Procedure to 30 days

Results

Posted Oct 6, 2010

Participant flow

Participant flow — Overall Study
Milestone	FLAIR Endovascular Stent Graft
Started	30
Completed	30
Not completed	0

Outcome measures

PrimaryTechnical Success for Delivery

defined as deployment of the implant to the intended location, assessed at the time of the index procedure.

Time frame:: Measured at the time of implantation (Day 0)
Reported as:: Number · Percentage of successful implantations

Technical Success for Delivery
Percentage of successful implantations	FLAIR Endovascular Stent Graft
Technical Success for Delivery	100

SecondaryNumber of Device/Procedure-related Adverse Events(Safety of Delivery)

Device/Procedure-related adverse events from the index procedure through 30 days post procedure

Time frame:: Index Procedure to 30 days
Reported as:: Number · Number of Device/Procedure events

Number of Device/Procedure-related Adverse Events(Safety of Delivery)
Number of Device/Procedure events	FLAIR Endovascular Stent Graft
Number of Device/Procedure-related Adverse Events(Safety of Delivery)	1

Adverse events

Collected over 30 days post implantation. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
FLAIR Endovascular Stent Graft	—	0/30 (0%)	3/30 (10%)

Most frequent other events

Most frequent other events
Event	FLAIR Endovascular Stent Graft
Thrombosis of Access CircuitBlood and lymphatic system disorders	3/30

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	FLAIR Endovascular Stent Graft
<=18 years	0
Between 18 and 65 years	13
>=65 years	17

Age, Continuous
Age, Continuous(years)	FLAIR Endovascular Stent Graft
Mean	64.8 ± 15.14

Gender
Gender(Participants)	FLAIR Endovascular Stent Graft
Female	17
Male	13

Region of Enrollment
Region of Enrollment(participants)	FLAIR Endovascular Stent Graft
United States	30

Study locations

1 site

Connecticut Image Guided Surgery
Fairfield, Connecticut 06825, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00614315
Lead sponsor: C. R. Bard
Responsible party: Sponsor
First posted: Feb 13, 2008
Start date: Dec 2007
Primary completion: Feb 2008
Completion: Feb 2008
Results posted: Oct 6, 2010
Last update: Feb 28, 2017

Study contacts

Melvin Rosenblatt, M.D.

principal investigator · Connecticut Image Guided Surgery

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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