A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Vascular Therapies, Inc.
- Enrollment
- 269
- Locations
- 4
- Primary Endpoint
- Fistula Suitability for Dialysis at 6 Months (FSD6)
Study Overview
Brief Summary
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).
Detailed Description
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure). Following successful creation of the AV fistula, the cohort randomized to the treatment group will receive the SeCI; the control group will not receive an implant. The primary hypothesis is that the proportion of subjects that meet requirements for fistula suitability for dialysis six months following the index procedure will be higher in the treatment group in comparison to the control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Currently on hemodialysis for ≤12 months or expected to initiate hemodialysis within approximately 6 months of the creation of the AV fistula.
- •Vascular anatomy suitable for creation of the AV fistula, determined by pre procedure duplex ultrasound
- •Successful creation of a single stage radiocephalic or brachiocephalic end to side fistula
Exclusion Criteria
- •Prior AV access created on the limb where the fistula surgery is planned
- •ST-elevation MI or cerebrovascular accident within 30 days of the index procedure
- •Known hypersensitivity to the following: sirolimus, beef or bovine collagen
- •Hypotension with systolic blood pressures <100 mm Hg at the time of screening
- •Known or suspected active infection at the time of the AV fistula surgery
- •Known to be HIV positive
- •Prisoner, mentally incompetent, and/or alcohol or drug abuser
Arms & Interventions
Treatment Group
AV fistula surgery Single administration of sirolimus-eluting Collagen implant
Intervention: Sirolimus (Drug)
Treatment Group
AV fistula surgery Single administration of sirolimus-eluting Collagen implant
Intervention: AV Fistula Surgery (Procedure)
Treatment Group
AV fistula surgery Single administration of sirolimus-eluting Collagen implant
Intervention: Sirolimus-eluting Collagen Implant (SeCI) (Device)
Control Group
AV fistula surgery
Intervention: AV Fistula Surgery (Procedure)
Outcomes
Primary Outcomes
Fistula Suitability for Dialysis at 6 Months (FSD6)
Time Frame: 6 months
For subjects who are on hemodialysis by day 150, suitability for dialysis will be determined by the ability to use the fistula for dialysis using 2-needles with a mean dialysis machine blood pump speed of ≥300 mL/min for two-thirds of the dialysis sessions during a 30 day suitability ascertainment period that begins 150 days after fistula creation. For subjects who are not on hemodialysis on day of enrollment and who do not initiate hemodialysis by day 150, suitability for dialysis will be determined by a vascular ultrasound performed at the 6 month follow up visit. Suitability for dialysis will be defined as a fistula with an access vein diameter (AVD) of ≥6 mm (internal diameter) and an access blood flow of ≥500 mL/min.
Secondary Outcomes
No secondary outcomes reported