NCT00318851

Brief Summary

The purpose of this study is to evaluate ischemic events and neuropsychological changes after carotid artery angioplasty and stenting with a neuroprotection device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 26, 2010

Status Verified

March 1, 2006

Enrollment Period

3.9 years

First QC Date

April 25, 2006

Last Update Submit

August 25, 2010

Conditions

Carotid Artery Stenosis

Keywords

Carotid Artery stentingStroke

Outcome Measures

Primary Outcomes (1)

  • Number of new diffusion weighted abnormalities post-procedure

    24 hours post stent placement

Secondary Outcomes (14)

  • Neuropsychological stability or deterioration

    3 months post procedure

  • Neuropsychological stability or deterioration

    6 months post procedure

  • Neuropsychological stability or deterioration

    12 months post procedure

  • Acute versus delayed neuropsychological changes

    1-7 days post procedure

  • Acute versus delayed neuropsychological changes

    3 months post procedure

  • +9 more secondary outcomes

Study Arms (1)

Carotid Artery Stenting

EXPERIMENTAL
Device: Carotid Stent with Distal Protection Device

Interventions

Carotid Stent with Distal Protection DeviceDEVICE

Carotid Stent Placement with Distal Protection

Also known as: Carotid Artery Stenting, Neurocognitive evaluation in Carotid Artery Stenting
Carotid Artery Stenting

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 and less than 90
  • Symptomatic as evidenced by transient ischemic attack or non-disabling stroke in the hemisphere supplied by the target vessel within 180 days of procedure. Must have anatomic stenosis greater than 70% by ultrasound or angiography performed in previous 30 days
  • Asymptomatic patients with a stenosis greater than 80% by ultrasound or angiography performed in previous 30 days
  • Patient has no childbearing potential or has negative pregnancy tests within one week prior to procedure.
  • Patient and patient's physician agree to have the patient return for all the required clinical contacts following study enrollment
  • Patient signs informed consent
  • Patient has been excluded from other multi-institutional trials

You may not qualify if:

  • Patient has evolving stroke or intracranial hemorrhage
  • Allergy to trial required medications
  • Active bleeding diathesis or coagulopathy, or will refuse blood transfusions
  • History of major ipsilateral stroke with sufficient atrophy to increase risk of procedure associated bleed
  • Severe dementia
  • Previous intracranial hemorrhage or brain surgery within the past twelve months
  • Patient has any condition that precludes angiography or would make a percutaneous procedure unsafe
  • Patient or family inability to understand or cooperate with study procedures
  • Recent GI or remote bleed that would interfere with anti-plate therapy
  • Severe vessel tortuosity or calcification that would preclude introduction of guiding catheter, guiding sheath, or stent placement
  • Extensive diffuse atherosclerotic disease involving the arch or common carotid that would preclude safe introduction of catheters and sheaths for endovascular therapy
  • Intraluminal filling defect
  • Intracranial aneurysm greater than 6 mm, AVM, or other intracranial vascular abnormality that would preclude safe intravascular intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Carotid StenosisStroke

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rodney D. Raabe, MD

    Providence Health & Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

September 1, 2003

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

August 26, 2010

Record last verified: 2006-03

Locations

US(1)