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

• Sponsor: Vascular Therapies, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02513303
• Collaborator: (none)
• Enrollment: 269
• Locations: 4
• Arms: 2
• Duration (Months): 67
• Patients Per Site: 67.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Complication of Renal Dialysis; End Stage Renal Disease; End Stage Kidney Disease; ESRD; Chronic Kidney Failure; Complication of Hemodialysis; Vascular Access Complication; Arteriovenous Fistula	Drug: Sirolimus; Procedure: AV Fistula Surgery; Device: Sirolimus-eluting Collagen Implant (SeCI)	Phase 3

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
• Actual Enrollment: 269 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group AV fistula surgery Single administration of sirolimus-eluting Collagen implant	Drug: Sirolimus; A single dose of sirolimus delivered locally; Other Names: Rapamycin ; 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.; Other Names: Rapamycin
Other: Control Group AV fistula surgery	Procedure: AV Fistula Surgery; AV Fistula Surgery

Outcome Measures

Primary Outcome Measures

1. Fistula Suitability for Dialysis at 6 Months (FSD6) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nephrology Consultants, LLC	Huntsville	Alabama	United States	35805
2	AKDHC Medical Research Service	Phoenix	Arizona	United States	85012
3	San Diego Institute of Medical Research	Escondido	California	United States	92025
4	Northeast Clinical Research Center	Bethlehem	Pennsylvania	United States	18017

Sponsors and Collaborators

• Vascular Therapies, Inc.

Investigators

• Study Director: Sriram Iyer, MD, Vascular Therapies, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vascular Therapies, Inc.
• ClinicalTrials.gov Identifier: NCT02513303
• Other Study ID Numbers: VT-304
• First Posted: Jul 31, 2015
• Last Update Posted: Jul 22, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vascular Therapies, Inc.: Dialysis; End Stage Renal Disease; End Stage Kidney Disease; ESRD; Chronic Kidney Failure; Chronic Renal Failure; Chronic Kidney Disease; Hemodialysis; Vascular Access; Arteriovenous Fistula; AV Fistula; AVF; Nephrology; Vascular Surgery; Dialysis Access
• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Arteriovenous Fistula; Fistula; Sirolimus

Study Results

No Results Posted as of Jul 22, 2021