End Stage Renal Disease Clinical Trial
— ACCESSOfficial title:
A Phase 3, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus-Eluting Collagen Implant
NCT number | NCT02513303 |
Other study ID # | VT-304 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | June 2021 |
Verified date | July 2021 |
Source | Vascular Therapies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 269 |
Est. completion date | June 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northeast Clinical Research Center | Bethlehem | Pennsylvania |
United States | San Diego Institute of Medical Research | Escondido | California |
United States | Nephrology Consultants, LLC | Huntsville | Alabama |
United States | AKDHC Medical Research Service | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Vascular Therapies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fistula Suitability for Dialysis at 6 Months (FSD6) | 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. |
6 months |
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