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CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation

Primary Purpose

Carotid Artery Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IVUS
CAS
CEA
Sponsored by
Arizona Heart Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Disease focused on measuring CAD, CEA, CAS, IVUS, symptomatic, asymptomatic, Cerebral Protection Device, TIA, Stroke, plaque morphology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Heart Institute

Outcomes

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.

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.

Full Information

First Posted
December 29, 2005
Last Updated
October 24, 2007
Sponsor
Arizona Heart Institute
Collaborators
Volcano Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00271076
Brief Title
CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation
Official Title
Carotid Artery Plaque Intravascular Ultrasound Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Arizona Heart Institute
Collaborators
Volcano Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Disease
Keywords
CAD, CEA, CAS, IVUS, symptomatic, asymptomatic, Cerebral Protection Device, TIA, Stroke, plaque morphology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
IVUS
Intervention Type
Device
Intervention Name(s)
CAS
Intervention Type
Procedure
Intervention Name(s)
CEA
Primary Outcome Measure Information:
Title
Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward B Diethrich, M.D.
Organizational Affiliation
Arizona Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grayson H Wheatley, M.D.
Organizational Affiliation
Arizona Heart Institute
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Heart Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States

12. IPD Sharing Statement

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CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation

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