CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation

NCT00271076 | Completed Phase 1

• 2 other identifiers: AHI # 1119Volcano Therapeutics
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

IVUS PROCEDURE

CAS DEVICE

CEA PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona Heart Institute: lead
• Volcano Corporation: collaborator

Study Sites (1)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Edward B Diethrich, M.D.

  Arizona Heart Institute

  PRINCIPAL INVESTIGATOR

• Grayson H Wheatley, M.D.

  Arizona Heart Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: December 30, 2005
• Study Start: January 1, 2006
• Study Completion: September 1, 2007
• Last Updated: October 25, 2007

Record last verified: 2007-10

Locations

US (1)