FLAIR™ Delivery System Study (FLAIR DS)

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

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

Study Overview

• Status: Completed
• Conditions: Constriction, Pathologic
• Intervention / Treatment: Device: FLAIR™ Endovascular Stent Graft

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Fairfield, Connecticut, United States, 06825
      • Connecticut Image Guided Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLAIR Endovascular Stent Graft and Delivery System	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Melvin Rosenblatt, M.D., Connecticut Image Guided Surgery

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: February 11, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: January 14, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: BPV-07-001