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Safety and Efficacy of the Sirolimus-Eluting Collagen Implant to Assess AV Fistula Outcomes in Patients on Hemodialysis (ACCESS)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Vascular Therapies, Inc.
Sponsor:
Information provided by (Responsible Party):
Vascular Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT02513303
First received: July 29, 2015
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to determine whether the use of the Sirolimus-eluting Collagen Implant will improve AV Fistula outcomes, including time to first dialysis and suitability for dialysis at 6 months, 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 in Subjects on Hemodialysis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to first dialysis (TTFD) [ Time Frame: Assessments to determine the suitability for first cannulation of the AV fistula will start 28 days following surgery. ]
    Time To First Dialysis (TTFD): defined as the time from fistula creation to the time when the fistula can support three consecutive dialysis sessions using 2-needles with a mean dialysis machine blood pump speed of ≥300 mL/min.


Secondary 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 ]
    Fistula Suitability for Dialysis at 6 Months (FSD6): defined as 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.


Estimated Enrollment: 245
Study Start Date: November 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (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

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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 29, 2015
Last Updated: August 8, 2016

Keywords provided by Vascular Therapies, Inc.:
Vascular Access
Dialysis Access
Dialysis
End Stage Renal Disease
End Stage Kidney Disease
ESRD
Chronic Kidney Failure
Chronic Renal Failure
Chronic Kidney Disease
Hemodialysis
Arteriovenous Fistula
AV Fistula
AVF
Nephrology
Vascular Surgery

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Fistula
Renal Insufficiency
Arteriovenous Fistula
Urologic Diseases
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

ClinicalTrials.gov processed this record on September 19, 2017