| Trial ID: | L1639 |
| Source ID: | NCT02513303
|
| Associated Drug: |
Sirolimus
|
| Title: |
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
|
| Acronym: |
ACCESS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| 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
|
| Interventions: |
DRUG: Sirolimus|PROCEDURE: AV Fistula Surgery|DEVICE: Sirolimus-eluting Collagen Implant (SeCI)
|
| Outcome Measures: |
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 |
|
| Sponsor/Collaborators: |
Sponsor: Vascular Therapies, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
269
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2015-11
|
| Completion Date: |
2021-06
|
| Results First Posted: |
|
| Last Update Posted: |
2021-07-22
|
| Locations: |
Nephrology Consultants, LLC, Huntsville, Alabama, 35805, United States|AKDHC Medical Research Service, Phoenix, Arizona, 85012, United States|San Diego Institute of Medical Research, Escondido, California, 92025, United States|Northeast Clinical Research Center, Bethlehem, Pennsylvania, 18017, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02513303
|
