CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation

Condition(s) targeted: Carotid Artery Disease

Intervention: IVUS (Procedure); CAS (Device); CEA (Procedure)

Phase: Phase 1

Status: Completed

Sponsored by: Arizona Heart Institute

Official(s) and/or principal investigator(s):
Edward B Diethrich, M.D., Principal Investigator, Affiliation: Arizona Heart Institute
Grayson H Wheatley, M.D., Study Director, Affiliation: Arizona Heart Institute

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.

Official title: Carotid Artery Plaque Intravascular Ultrasound Evaluation

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

Primary outcome: 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: 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.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Arizona Heart Institute, Phoenix, Arizona 85006, United States

Arizona Heart Institute

Starting date: January 2006
Ending date: September 2007
Last updated: October 24, 2007