Clinical trial NCT02513303: Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
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
Lead sponsor: Vascular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-31
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

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

Primary outcomes:
measure: Fistula Suitability for Dialysis at 6 Months (FSD6)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants, LLC
state: Alabama
city: Phoenix
country: United States
facility: AKDHC Medical Research Service
state: Arizona
city: Escondido
country: United States
facility: San Diego Institute of Medical Research
state: California
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center
state: Pennsylvania
Study officials:
affiliation: Vascular Therapies, Inc.
name: Sriram Iyer, MD
role: STUDY_DIRECTOR
References: