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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02513303
The ClinicalTrials.gov registry entry for NCT02513303 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 269 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 830-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (68% lower). The listed sponsor is Vascular Therapies, which has 2 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.