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FLAIR™ Delivery System Study (FLAIR DS)

This study has been completed.
Sponsor:
Information provided by:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00614315
First received: December 18, 2007
Last updated: October 20, 2010
Last verified: October 2010
History of Changes
  Purpose

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


Condition Intervention
Constriction, Pathologic
 Device: FLAIR™ Endovascular Stent Graft

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Observational Study of the FLAIR™ Endovascular Stent Graft Optimized Delivery System

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Technical Success for Delivery [ Time Frame: Measured at the time of implantation (Day 0) ] [ Designated as safety issue: No ]
    defined as deployment of the implant to the intended location, assessed at the time of the index procedure.


Secondary Outcome Measures:
  • Number of Device/Procedure-related Adverse Events(Safety of Delivery) [ Time Frame: Index Procedure to 30 days ] [ Designated as safety issue: Yes ]
    Device/Procedure-related adverse events from the index procedure through 30 days post procedure


Enrollment: 30
Study Start Date: December 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614315

Locations
United States, Connecticut
Connecticut Image Guided Surgery
Fairfield, Connecticut, United States, 06825
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Melvin Rosenblatt, M.D. Connecticut Image Guided Surgery
  More Information

No publications provided

Responsible Party: John Reviere, Director, Clinical Affairs, Bard Peripheral Vascular, Inc.
ClinicalTrials.gov Identifier: NCT00614315     History of Changes
Other Study ID Numbers: BPV-07-001
Study First Received: December 18, 2007
Results First Received: February 20, 2009
Last Updated: October 20, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013