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NCT02513303 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
A Phase 3 study of End Stage Renal Disease and End-Stage Kidney Disease, sponsored by Vascular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 269
- Enrollment target
- 4
- Study locations
NCT02513303: Completed Phase 3 study of End Stage Renal Disease and End-Stage Kidney Disease, sponsored by Vascular Therapies.
NCT02513303 is a Phase 3 study of End Stage Renal Disease and End-Stage Kidney Disease that has completed, run by Vascular Therapies. The registered enrollment target is 269 participants, below the 830-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (68% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02513303, a Phase 3 study of End Stage Renal Disease and End-Stage Kidney Disease, has completed, sponsored by Vascular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 269 participants
- Enrollment target
- 4
- Study locations
Study 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).
Primary Outcome
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 dete
Conditions Studied
Interventions
- DRUG Sirolimus
- PROCEDURE AV Fistula Surgery
- DEVICE Sirolimus-eluting Collagen Implant (SeCI)
Study Locations (4)
Alabama
- Nephrology Consultants, LLC - Huntsville
Arizona
- AKDHC Medical Research Service - Phoenix
California
- San Diego Institute of Medical Research - Escondido
Pennsylvania
- Northeast Clinical Research Center - Bethlehem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2015-11 |
| Est. Completion | 2021-06 |
| Phase | Phase 3 |
What the finished NCT02513303 record still lists
NCT02513303 is an interventional study that assigns participants to a tested intervention. The registered 269 participants enrollment target is mid-sized for trials with a published cap, below the 830-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (68% lower).
The record links to 8 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 3 interventions - of which Sirolimus is the first listed.
NCT02513303 reports a single indexed study location in Alabama, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT02513303 about?
NCT02513303 is a clinical study titled "Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes". 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).
What is the current status of trial NCT02513303?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 269 participants. The study started on 2015-11. Estimated completion is 2021-06.
What conditions does trial NCT02513303 study?
This clinical trial studies the following conditions: End Stage Renal Disease, End-Stage Kidney Disease, ESRD, Arteriovenous Fistula, Vascular Access Complication.
What interventions are being tested in trial NCT02513303?
The interventions under investigation include: Sirolimus (DRUG), AV Fistula Surgery (PROCEDURE), Sirolimus-eluting Collagen Implant (SeCI) (DEVICE).
Who is sponsoring clinical trial NCT02513303?
This trial is sponsored by Vascular Therapies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02513303 being conducted?
This trial has 4 study locations across Alabama, Arizona, California, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02513303's enrollment target sits among peer trials
269 20th of 86 higher than 67 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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