Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Anesiva, Inc.
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Anticipate receipt of a renal transplant within 6 months of enrollment into this study
Have anticipated use of the index PTFE graft \<14 days after enrollment (this does not apply to Vectragraft®)
Have a known allergy to iodinated contrast
Have a known hypercoagulable state (e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating lupus anticoagulant; current, active, heparin-induced thrombocytopenia; Protein C or S deficiency; or a history of recurrent deep venous thrombosis not related to AV access)
Have been in another investigational (i.e., nonapproved) drug or device study within the previous 30 days or prior participation in another clinical study with E2F Decoy
Have been previously enrolled in this study for an earlier access graft
Have any comorbid, nonrenal condition that makes 6-month survival questionable (e.g., end-stage cancer, advanced heart failure)
Have a known or suspected history of drug or alcohol abuse within the previous 6 months
Have a known allergy to any component of the investigational product (drug or device), including latex
