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).
Brief Title
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
Detailed Description
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.
Categories
Completion Date
Completion Date Type
Actual
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
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02513303
Org Class
Industry
Org Full Name
Vascular Therapies, Inc.
Org Study Id
VT-304
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant
Primary Outcomes
Outcome Description
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.
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.
Outcome Measure
Fistula Suitability for Dialysis at 6 Months (FSD6)
Outcome Time Frame
6 months
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Larry Scher
Investigator Email
lscher@montefiore.org