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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: Completed NA study, sponsored by Cedars-Sinai Medical Center.
NCT01819597 is a NA study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 52 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary study endpoint is the number of participants with any stroke or death within 30 days after enrollment, or any ischemic stroke or death attributable to ischemia in the territory of the qualifying artery at one year. Ischemic stroke is defined as a new focal neurological deficit of sudden onset, lasting at least 24 hours and not associated with CT or MRI findings of hemorrhage.
Interventions
- PROCEDURE Encephaloduroarteriosynangiosis (EDAS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2013-03 |
| Est. Completion | 2018-06 |
| Phase | NA |
What the finished NCT01819597 record still lists
NCT01819597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Encephaloduroarteriosynangiosis (EDAS) is the first listed.
NCT01819597 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01819597's enrollment target sits among peer trials
52 1272nd of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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