Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vascular Therapies, Inc.
• Treatments: Everolimus; Sirolimus

Criteria

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