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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05425056
Other study ID # VT-305
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 26, 2022
Est. completion date September 2024

Study information

Verified date November 2023
Source Vascular Therapies, Inc.
Contact Rakesh Raghubanshi
Phone 201-266-8310
Email rakesh@vascualrtx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.


Description:

This is a Phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects who are on hemodialysis and are undergoing surgical creation of an AV fistula in comparison to subjects who do not receive the implant. Subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation will be eligible for enrollment. The study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. Enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Age 65 years or older - Currently on hemodialysis for =12 months - Successful creation of a single stage radiocephalic end to side fistula Exclusion Criteria: - Prior AV access created on the limb where the fistula surgery is planned - Planned start of peritoneal dialysis within 6 months of randomization - Known hypersensitivity to the following: sirolimus, beef or bovine collagen - Known to be HIV positive - Prisoner, mentally incompetent, and/or current alcohol or drug abuser

Study Design


Intervention

Drug:
Sirolimus
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 Kingdom University Hospitals Birmingham NHS Foundation Trust Birmingham
United Kingdom NHS Greater Glasgow and Clyde Glasgow
United Kingdom Barts Health NHS Trust of Royal London Hospital London
United Kingdom St George's University Hospitals NHS Foundation Trust London
United States Lehigh Valley Health Network Allentown Pennsylvania
United States Emory University Hospital Midtown Atlanta Georgia
United States Augusta University Augusta Georgia
United States The Brigham and Women's Hospital Boston Massachusetts
United States Atrium Health Charlotte North Carolina
United States Surgical Specialists of Charlotte Charlotte North Carolina
United States Arteries & Veins El Paso Texas
United States Houston Methodist Houston Texas
United States University of Louisville Louisville Kentucky
United States James Eric Gardner, MD PC Memphis Tennessee
United States American Access Care of Miami Miami Florida
United States Yale University New Haven Connecticut
United States Mount Sinai Hospital New York New York
United States Sentara Norfolk General Hospital/Sentara Health Research Center Norfolk Virginia
United States The Regional Medical Center/Dialysis Access Institute Orangeburg South Carolina
United States Veterans Affairs San Diego Health Center San Diego California
United States Houston Methodist Sugar Land Texas
United States Lundquist Institute for Biomedical Innovation Torrance California
United States MedStar Cardiovascular Research Network at MedStar Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Vascular Therapies, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Fistula Maturation (FM) Clinical Fistula Maturation (FM) is defined as a fistula that can be cannulated with 2-needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of 300 mL/min (unless the prescribed Qb is <300 mL/min) performed during any continuous 30 day period that commences no later than 180 days after randomization.
The primary endpoint will be summarized as a time-to-event endpoint for the SeCI (Sirogen) and control groups by reporting the cumulative proportion of AVF that achieve FM over time [defined as the interval from access placement to the first session that the fistula can be cannulated with 2 needles (contributing to the FM definition)].
6 Months
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