Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemo… (NCT00086164) | Clinical Trial Compass
TerminatedPhase 1/2
Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemodialysis
United StatesStarted 2004-05
Plain-language summary
The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment.
Who can participate
Age range18 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be scheduled to undergo placement of a new straight or loop arm PTFE arteriovenous hemodialysis access graft or a Vectragraft® (Thoratec, Inc.)
* Be currently receiving chronic dialysis or be expected to begin hemodialysis within 4 weeks of placement of the index PTFE graft
* Have undergone an assessment of patency (such as venography) of central veins if any of the following conditions have occurred on the ipsilateral arm intended for graft placement: presence of collateral veins, upper extremity edema or increased size (relative to the contralateral arm), history of subclavian catheter, transvenous pacemaker, or history of trauma or surgery that may have involved the neck or chest veins
* Be \> 18 and \<80 years old
* Have a documented negative serum pregnancy test (for all women of childbearing potential)
* Be using an acceptable method of birth control if of reproductive potential and agree to continue using the birth control for at least 3 months following the graft procedure
* Have agreed to participate voluntarily and have signed and dated an IRB/EC approved, Patient Informed Consent form
Exclusion Criteria:
* Have an intended recipient vein \>6 mm or \<3 mm in diameter
* Have a history of three or more previous PTFE grafts
* Have uncorrected central vein (including the subclavian vein) stenosis
* Have markedly diminished arterial pulses in the access location (unless adequate flow has been documented by arteriography or Doppler ultrasound)
* A…