Clinical trial NCT00614315: FLAIR™ Delivery System Study
Official title: A Prospective Observational Study of the FLAIR™ Endovascular Stent Graft Optimized Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constriction, Pathologic
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Technical Success for Delivery
timeFrame: Measured at the time of implantation (Day 0)
Secondary outcomes:
measure: Number of Device/Procedure-related Adverse Events(Safety of Delivery)
timeFrame: Index Procedure to 30 days
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Connecticut Image Guided Surgery
state: Connecticut
Study officials:
affiliation: Connecticut Image Guided Surgery
name: Melvin Rosenblatt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: