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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02513303
Recruitment Status : Active, not recruiting
First Posted : July 31, 2015
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Vascular Therapies, Inc.

Study Description
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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). 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.

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 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Fistula Suitability for Dialysis at 6 Months (FSD6) [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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United States, Alabama
Nephrology Consultants, LLC
Huntsville, Alabama, United States, 35805
United States, Arizona
AKDHC Medical Research Service
Phoenix, Arizona, United States, 85012
United States, California
San Diego Institute of Medical Research
Escondido, California, United States, 92025
United States, Pennsylvania
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States, 18017
Sponsors and Collaborators
Vascular Therapies, Inc.
Investigators
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Study Director: Sriram Iyer, MD Vascular Therapies, Inc.
More Information
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Responsible Party: Vascular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02513303    
Other Study ID Numbers: VT-304
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: August 2019
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:
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Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Arteriovenous Fistula
Fistula
Urologic Diseases
Renal Insufficiency, Chronic
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
 Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs