Expired Study
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Fairfield, Connecticut 06825


Purpose:

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


Criteria:

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: - 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 is Available At:


Original ID:

BPV-07-001


NCT ID:

NCT00614315


Secondary ID:


Study Acronym:

FLAIR DS


Brief Title:

FLAIR™ Delivery System Study


Official Title:

A Prospective Observational Study of the FLAIR™ Endovascular Stent Graft Optimized Delivery System


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

C. R. Bard


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Actual


Overall Contact Information

Official Name:Melvin Rosenblatt, M.D.
Principal Investigator
Connecticut Image Guided Surgery

Study Dates

Start Date:December 2007
Completion Date:February 2008
Completion Type:Actual
Primary Completion Date:February 2008
Primary Completion Type:Actual
Verification Date:October 2010
Last Changed Date:October 20, 2010
First Received Date:December 18, 2007
First Results Date:February 20, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Technical Success for Delivery
Time Frame:Measured at the time of implantation (Day 0)
Safety Issues:False
Description:defined as deployment of the implant to the intended location, assessed at the time of the index procedure.
Outcome Type:Secondary Outcome
Measure:Number of Device/Procedure-related Adverse Events(Safety of Delivery)
Time Frame:Index Procedure to 30 days
Safety Issues:True
Description:Device/Procedure-related adverse events from the index procedure through 30 days post procedure

Study Interventions

Intervention Type:Device
Name:FLAIR™ Endovascular Stent Graft
Description: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).
Arm Name:FLAIR Endovascular Stent Graft and Delivery System

Study Arms

Study Arm Type:Experimental
Arm Name:FLAIR Endovascular Stent Graft and Delivery System

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:C. R. Bard

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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