CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 29, 2005

Last Updated Date

October 24, 2007

Start Date ^†

January 2006

Current Primary Outcome Measures ^†

Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00271076 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Secondary endpoint: safety and feasibility of the catheter system with respect to the possibility of assisting with the selection of a carotid stent, the relevance of pre-stent ballooning and ultimately the best treatment modality.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation

Official Title ^†

Carotid Artery Plaque Intravascular Ultrasound Evaluation

Brief Summary

To assess the safety and feasibility of Volcano Corp Eagle Eye Gold Catheter system to correlate the presence and characteristic of carotid artery atherosclerotic disease with anatomic and histologic analysis.

Detailed Description

A Phase , single center, prospective safety and feasibility study in patients diagnosed with carotid artery disease requiring intervention (carotid endarterectomy(CEA) or carotid artery stenting (CAS) with distal protection) as determined by the attending physician per standard treatment guidelines.

At the time of the procedure, patients will undergo peri-operative assessment of their carotid artery disease with the study device.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^†

Carotid Artery Disease

Intervention ^†

Procedure: IVUS
Device: CAS
Procedure: CEA

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

>18 years of age
Patient must be:

Symptomatic with lesions >/= to 50% stenosis, or Asymptomatic with lesions of >/= to 75% stenosis in at least one carotid artery, specific to the internal carotid artery, common carotid artery or bifurcated region; documented through acceptable ultrasound studies, completed within 30 days of recruitment.

For patients with bilateral carotid disease- procedures need to be staged greater than 30 days apart. The lesion that has a greater degree of stenosis will be considered as the index procedure.
Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment.
The patient is able to give informed consent.

Exclusion Criteria:

The patient is experiencing a new (acute) neurologic event or has experienced a stroke within the last 30 days prior to enrollment.
The patient has intracranial tumors, arterial vascular malformations >5mm, aneurysms or severe intracranial stenosis distal to the target lesion.
Presence of thrombus at the target site or loose 'floating' debris as determined by duplex analysis and/or angiography.
Existing hemorrhagic disease or coagulation problems creating inability to obtain homeostasis at entry site.
The patient has an allergy to, or is unable to tolerate, heparin, concomitant medications (clopidogrel or ticlid, aspirin) or to nitinol metal.
The patient has a history of or known reaction to radiocontrast agent (radiopaque dye) and is unable to be premedicated.
Coumadin treatment that has continued during the 48 hours prior to enrollment and an INR above hospital normals (i.e. in the event of atrial fibrillation or prosthetic valve replacement).
Hemodynamic instability at the time of intervention.
Severe chronic renal insufficiency (plasma/ serum creatinine> 2.5 mg/dL) at the time of intervention, except in patients on dialysis.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00271076

Responsible Party

Secondary IDs ^††

Volcano Therapeutics

Study Sponsor ^†

Arizona Heart Institute

Collaborators ^††

Volcano Corporation

Investigators ^†

Principal Investigator:	Edward B Diethrich, M.D.	Arizona Heart Institute
Study Director:	Grayson H Wheatley, M.D.	Arizona Heart Institute

Information Provided By

Arizona Heart Institute

Verification Date

October 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.