Delivery of Inhibitors of Lysyl Oxidase (LysoLox) on Serial Angioplasty and Time to Restenosis
Arteriovenous Fistula Occlusion
About this trial
This is an interventional treatment trial for Arteriovenous Fistula Occlusion
Eligibility Criteria
Inclusion Criteria:
- Age 18 and < 90 years old
- Receiving stable out-subject hemodialysis for a minimum of 3 months
- Have a lower arm or upper arm AVF that has been cleared for use by the vascular surgeon or interventional nephrologist
- Have agreed to participate voluntarily and signed and dated an IRB approved, subject informed consent form
Dysfunctional Dialysis Fistula: Any subject with
- Two or more venous pressure readings exceeding 250 mmHg for a minimum of 5 minutes at a blood flow of 500mls/min within a single dialysis run AND a documented reduction in KT/V by > 0.2; OR
- Patients with venous pressures > 250 mm Hg on two or more days within a 30 day period OR
- Patients who on physical exam are found to have palpable obstructions, post-stenotic dilation of the access or evidence of prolonged post-dialysis bleeding.
- Any patient with one of the above conditions will be to have a dysfunctional AVF. This definition will be applied to the screening of study subjects as well as the determination of recurrent fistula dysfunction at 12 months.
Exclusion Criteria:
- Scheduled for surgical revision of the fistula;
Have been in another investigational (non-approved) drug or device study within the previous 30 days;
**have a known allergy to any component of the investigational product (drug or device)
- Subjects with a "Hero Graft" will be excluded from the study
- Subjects having received a stent for correction of a prior stenosis will be excluded from the trial
- Subjects with more than > 3 hemodynamically significant stenosis at one time (with the exception of a central venous stenosis)
- Subjects who are pregnant will be excluded from the trial (pregnancy test will be performed on subjects of child bearing potential). A urine pregnancy test will be utilized.
Sites / Locations
- Southeast Renal Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Active Comparator
Active Comparator
Low frequency angioplasty
Moderate frequency angioplasty
High frequency angioplasty
Subjects who have had 0-1 angioplasty during the 12 months prior to randomization. Subjects will have endoluminal biopsy prior to angioplasty but will not have insertion of the ACT drug delivery catheter
Subjects who have had 2-3 angioplasties during the 12 months prior to randomization. Subjects will have endoluminal biopsy prior to angioplasty followed by insertion of the ACT drug delivery catheter where ascorbic acid (10.0 µM) will be injected following conventional balloon angioplasty
High frequency angioplasty defined by 4 or more angioplasties 12 months prior to randomization. Subjects will receive ascorbic acid (10.0 µM) in combination with D-penicillamine (25 µM) will be injected following conventional balloon angioplasty