Status:
COMPLETED
FLAIR™ Delivery System Study
Lead Sponsor:
C. R. Bard
Conditions:
Constriction, Pathologic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this clinical study is to evaluate the performance of the Optimized FLAIR™ Delivery System.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00614315
Start Date
December 1 2007
End Date
February 1 2008
Last Update
February 28 2017
Active Locations (1)
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1
Connecticut Image Guided Surgery
Fairfield, Connecticut, United States, 06825