FLAIR™ Delivery System Study

Constriction, Pathologic Clinical Trial

— FLAIR DS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614315
• Other study ID #: BPV-07-001
• Status: Completed
• Phase: N/A
• First received: December 18, 2007
• Last updated: October 20, 2010
• Start date: December 2007
• Est. completion date: February 2008

Study information

• Verified date: October 2010
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic

Intervention

Device:
• FLAIR™ 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).

Locations

Country	Name	City	State
United States	Connecticut Image Guided Surgery	Fairfield	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success for Delivery	defined as deployment of the implant to the intended location, assessed at the time of the index procedure.	Measured at the time of implantation (Day 0)	No
Secondary	Number of Device/Procedure-related Adverse Events(Safety of Delivery)	Device/Procedure-related adverse events from the index procedure through 30 days post procedure	Index Procedure to 30 days	Yes