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

This study is currently recruiting participants.
Verified October 2017 by Vascular Therapies, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02513303
First Posted: July 31, 2015
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Vascular Therapies, Inc.
  Purpose
The purpose of this study is to determine whether the use of the Sirolimus-eluting Collagen Implant will improve AV fistula outcomes, including suitability for dialysis, and the proportion of subjects who maintain primary patency six months following the index procedure in subjects undergoing surgical creation of an AV fistula for providing vascular access for hemodialysis.

Condition Intervention 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 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Vascular Therapies, Inc.:

Primary Outcome Measures:
  • Fistula Suitability for Dialysis at 6 Months (FSD6) [ Time Frame: Assessed during a 30-day suitability ascertainment period that begins 150 days after fistula creation ]

    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.


  • Primary Patency at 6 months (PP6) [ Time Frame: Assessed 6 months following fistula creation ]
    Primary Patency is defined as freedom from the first occurrence of access thrombosis or an intervention performed to maintain or re-establish access patency or assist fistula maturation.


Estimated Enrollment: 245
Study Start Date: November 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group
AV fistula surgery with investigational product (Sirolimus-eluting Collagen Implant)
Drug: Sirolimus
Subjects in the treatment group will receive a single prophylactic dose of sirolimus delivered locally to the vessel wall at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery. Control group subjects will have surgery for creation of the AV fistula but will not receive the drug.
Other Name: Rapamycin
No Intervention: Control Group
AV fistula surgery without investigational product

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513303


Contacts
Contact: Rakesh Raghubanshi 201-266-8310 rakesh@vasculartx.com
Contact: David Kornhauser, EdD 954-341-1440 david@vasculartx.com

Locations
United States, Alabama
Nephrology Consultants, LLC Recruiting
Huntsville, Alabama, United States, 35805
Contact: Rakesh Raghubanshi    201-266-8310    rakesh@vasculartx.com   
United States, Arizona
AKDHC Medical Research Service Recruiting
Phoenix, Arizona, United States, 85012
Contact: Rakesh Raghubanshi    201-266-8310    rakesh@vasculartx.com   
United States, California
San Diego Institute of Medical Research Recruiting
Escondido, California, United States, 92025
Contact: Rakesh Raghubanshi    201-266-8310    rakesh@vasculartx.com   
United States, Pennsylvania
Northeast Clinical Research Center Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Rakesh Raghubanshi    201-266-8310    rakesh@vasculartx.com   
Sponsors and Collaborators
Vascular Therapies, Inc.
Investigators
Study Director: Sriram Iyer, MD Vascular Therapies, Inc.
  More Information

Responsible Party: Vascular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02513303     History of Changes
Other Study ID Numbers: VT-304
First Submitted: July 29, 2015
First Posted: July 31, 2015
Last Update Posted: November 1, 2017
Last Verified: October 2017

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
Fistula
Renal Insufficiency
Arteriovenous Fistula
Urologic Diseases
Renal Insufficiency, Chronic
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs