CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation

NCT ID: NCT00271076

Last Updated: 2007-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-09-30

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.

Conditions

Carotid Artery Disease

Keywords

CAD; CEA; CAS; IVUS; symptomatic; asymptomatic; Cerebral Protection Device; TIA; Stroke; plaque morphology

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

IVUS

Intervention Type: PROCEDURE

CAS

Intervention Type: DEVICE

CEA

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Volcano Corporation

INDUSTRY

Sponsor Role: collaborator

Arizona Heart Institute

OTHER

Sponsor Role: lead

Principal Investigators

Edward B Diethrich, M.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona Heart Institute

Grayson H Wheatley, M.D.

Role: STUDY_DIRECTOR

Arizona Heart Institute

Locations

Arizona Heart Institute

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

Volcano Therapeutics

Identifier Type: -

Identifier Source: secondary_id

AHI # 1119

Identifier Type: -

Identifier Source: org_study_id