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NCT01819597 · ClinicalTrials.gov registry record · NA
Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis
A NA study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT01819597 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 52 participants.
The verdict
NCT01819597, a NA study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study Summary
Stroke due to intracranial arterial atherosclerosis is a significant medical problem, carrying one of the highest rates of recurrent stroke despite best medical therapy, with annual recurrence rates as elevated as 25% in high risk groups. The goal of this investigation is to advance a promising surgical treatment for symptomatic atherosclerotic intracranial stenosis - encephaloduroarteriosynangiosis (EDAS). The investigation will test in a phase II futility trial the potential of EDAS for further development before proceeding with the design of a definitive clinical trial of EDAS Revascularization in patients with Symptomatic Intracranial Arterial Stenosis (ERSIAS). The investigation is a 4-year futility trial to test the hypothesis that EDAS revascularization combined with aggressive medical therapy warrants further evaluation in a subsequent pivotal trial as an alternative to aggressive medical management alone for preventing the primary endpoint of stroke or death in patients with symptomatic intracranial arterial stenosis (Specific Aim 1). During the investigation the time course of collateralogenesis and perfusion improvement following EDAS will also be evaluated (Specific Aim 2.
Interventions
- PROCEDURE Encephaloduroarteriosynangiosis (EDAS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2013-03 |
| Est. Completion | 2018-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01819597
The ClinicalTrials.gov registry entry for NCT01819597 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Encephaloduroarteriosynangiosis (EDAS) is the first listed.
NCT01819597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01819597 about?
NCT01819597 is a clinical study titled "Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis". Stroke due to intracranial arterial atherosclerosis is a significant medical problem, carrying one of the highest rates of recurrent stroke despite best medical therapy, with annual recurrence rates as elevated as 25% in high risk groups. The goal of this investigation is to advance a promising sur...
What is the current status of trial NCT01819597?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2013-03. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01819597?
The interventions under investigation include: Encephaloduroarteriosynangiosis (EDAS) (PROCEDURE).
Who is sponsoring clinical trial NCT01819597?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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