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

December 29, 2005
October 24, 2007
January 2006
Not Provided
Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter.
Same as current
Complete list of historical versions of study NCT00271076 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation
Carotid Artery Plaque Intravascular Ultrasound Evaluation

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carotid Artery Disease
  • Procedure: IVUS
  • Device: CAS
  • Procedure: CEA
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00271076
AHI # 1119, Volcano Therapeutics
Not Provided
Not Provided
Arizona Heart Institute
Volcano Corporation
Principal Investigator: Edward B Diethrich, M.D. Arizona Heart Institute
Study Director: Grayson H Wheatley, M.D. Arizona Heart Institute
Arizona Heart Institute
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP