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

NCT02513303 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: VT-304
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 4

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).

Conditions

Complication of Renal Dialysis; End Stage Renal Disease; End Stage Kidney Disease; ESRD; Chronic Kidney Failure; Complication of Hemodialysis; Vascular Access Complication; Arteriovenous Fistula

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

AV fistula surgery Single administration of sirolimus-eluting Collagen implant

Drug: Sirolimus; Procedure: AV Fistula Surgery; Device: Sirolimus-eluting Collagen Implant (SeCI)

Control Group

OTHER

AV fistula surgery

Procedure: AV Fistula Surgery

Interventions

Sirolimus DRUG

A single dose of sirolimus delivered locally

Also known as: Rapamycin

Treatment Group

AV Fistula Surgery PROCEDURE

AV Fistula Surgery

Control Group; Treatment Group

Sirolimus-eluting Collagen Implant (SeCI) DEVICE

SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.

Also known as: Rapamycin

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vascular Therapies, Inc.: lead

Study Sites (4)

Nephrology Consultants, LLC

Huntsville, Alabama, 35805, United States

Location

AKDHC Medical Research Service

Phoenix, Arizona, 85012, United States

Location

San Diego Institute of Medical Research

Escondido, California, 92025, United States

Location

Northeast Clinical Research Center

Bethlehem, Pennsylvania, 18017, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula; Renal Insufficiency, Chronic

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Rakesh Raghubanshi
• Organization: Vascular Therapies, Inc.

rakesh@vasculartx.com

9176204369

Study Officials

• Sriram Iyer, MD

  Vascular Therapies, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 31, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 9, 2025
• Results First Posted: October 9, 2025

Record last verified: 2025-09

Locations

US (4)