CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation

Carotid Artery Disease Clinical Trial

Official title:

Carotid Artery Plaque Intravascular Ultrasound Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271076
• Other study ID #: AHI # 1119
• Secondary ID: Volcano Therapeu
• Status: Completed
• Phase: Phase 1
• First received: December 29, 2005
• Last updated: October 24, 2007
• Start date: January 2006
• Est. completion date: September 2007

Study information

• Verified date: October 2007
• Source: Arizona Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases
• Carotid Stenosis

Intervention

Procedure:
• IVUS

Device:
• CAS

Procedure:
• CEA

Locations

Country	Name	City	State
United States	Arizona Heart Institute	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona Heart Institute	Volcano Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter.
Secondary	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.

External Links

•   Arizona Heart Institute