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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00271076 |
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Date of registration:
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29/12/2005 |
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Primary sponsor: |
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Public title:
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CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation
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Scientific title:
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Carotid Artery Plaque Intravascular Ultrasound Evaluation |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00271076 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Edward B Diethrich, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Arizona Heart Institute |
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Name:
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Grayson H Wheatley, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Arizona Heart Institute |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carotid Artery Disease
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Intervention(s)
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Device: CAS
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Procedure: CEA
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Procedure: IVUS
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Primary Outcome(s)
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Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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AHI # 1119
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Volcano Therapeutics
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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