NCT00315562

Brief Summary

Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 4, 2015

Status Verified

March 1, 2007

First QC Date

April 14, 2006

Last Update Submit

February 3, 2015

Conditions

StrokeCarotid Stenosis

Keywords

strokecarotid stenosiscarotid endarterectomytiming

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Score

    90 days

Secondary Outcomes (2)

  • stroke incidence

    90 days

  • transient ischemic attack incidence

    90 days

Study Arms (2)

Early

EXPERIMENTAL

Early

Procedure: carotid endarterectomy

Delayed

ACTIVE COMPARATOR

Delayed

Procedure: carotid endarterectomy

Interventions

carotid endarterectomyPROCEDURE
DelayedEarly

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older.
  • New small to medium-sized ischemic stroke (defined as less than 1/3 of the MCA territory) in the territory of 70% or greater carotid stenosis.
  • Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period.

You may not qualify if:

  • Patients judged to be a poor surgical candidate by the treating physicians.
  • Unstable neurological status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

StrokeCarotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCarotid Artery DiseasesArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Matt B Jensen, MD

    UCSD

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

April 1, 2006

Study Completion

March 1, 2007

Last Updated

February 4, 2015

Record last verified: 2007-03

Locations

US(1)