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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014