FLAIR™ Delivery System Study

NCT00614315 | Completed Results

• 1 other identifier: BPV-07-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Constriction, Pathologic

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

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

  Index Procedure to 30 days

Study Arms (1)

FLAIR Endovascular Stent Graft and Delivery System

EXPERIMENTAL

Device: FLAIR™ Endovascular Stent Graft

Interventions

FLAIR™ Endovascular Stent Graft DEVICE

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).

FLAIR Endovascular Stent Graft and Delivery System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Connecticut Image Guided Surgery

Fairfield, Connecticut, 06825, United States

Location

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: John Reviere, Director, Clinical Affairs
• Organization: Bard Peripheral Vascular, Inc.

John.Reviere@crbard.com

480-303-2644

Study Officials

• Melvin Rosenblatt, M.D.

  Connecticut Image Guided Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: February 13, 2008
• Study Start: December 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 28, 2017
• Results First Posted: October 6, 2010

Record last verified: 2017-01

Locations

US (1)