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

End Stage Renal Disease Clinical Trial

— ACCESS  

Official title:

A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513303
• Other study ID #: VT-304
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: June 2021

Study information

• Verified date: July 2021
• Source: Vascular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Failure
• Complication of Hemodialysis
• Complication of Renal Dialysis
• End Stage Kidney Disease
• End Stage Renal Disease
• ESRD
• Fistula
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Vascular Access Complication

Intervention

Drug:
• Sirolimus
A single dose of sirolimus delivered locally

Procedure:
• AV Fistula Surgery
AV Fistula Surgery

Device:
• Sirolimus-eluting Collagen Implant (SeCI)
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.

Locations

Country	Name	City	State
United States	Northeast Clinical Research Center	Bethlehem	Pennsylvania
United States	San Diego Institute of Medical Research	Escondido	California
United States	Nephrology Consultants, LLC	Huntsville	Alabama
United States	AKDHC Medical Research Service	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula Suitability for Dialysis at 6 Months (FSD6)	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.	6 months