CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation

This study has been completed.
Sponsor:
Collaborator:
Volcano Corporation
Information provided by:
Arizona Heart Institute
ClinicalTrials.gov Identifier:
NCT00271076
First received: December 29, 2005
Last updated: October 24, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Carotid Artery Disease
Procedure: IVUS
Device: CAS
Procedure: CEA
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carotid Artery Plaque Intravascular Ultrasound Evaluation

Resource links provided by NLM:


Further study details as provided by Arizona Heart Institute:

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.

Enrollment: 31
Study Start Date: January 2006
Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271076

Locations
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
Arizona Heart Institute
Volcano Corporation
Investigators
Principal Investigator: Edward B Diethrich, M.D. Arizona Heart Institute
Study Director: Grayson H Wheatley, M.D. Arizona Heart Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00271076     History of Changes
Other Study ID Numbers: AHI # 1119, Volcano Therapeutics
Study First Received: December 29, 2005
Last Updated: October 24, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Arizona Heart Institute:
CAD
CEA
CAS
IVUS
symptomatic
asymptomatic
Cerebral Protection Device
TIA
Stroke
plaque morphology

Additional relevant MeSH terms:
Carotid Artery Diseases
Carotid Stenosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 20, 2014