Carotid Artery DiseasePhase 1NCT00271076
CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation
A Phase 1 study testing IVUS, CAS and CEA in people with Carotid Artery Disease, run by Arizona Heart Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease
- What is being tested?
- IVUS, CAS and CEA
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Carotid Artery Disease
- Being tested
- IVUS, CAS, CEA
- Keywords
- CAD, CEA, CAS, IVUS, symptomatic, asymptomatic, Cerebral Protection Device, TIA, Stroke, plaque morphology
- Medical subject headings
- Carotid Artery Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUSProcedure or surgery
CASDevice
CEAProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startJan 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Volcano Corporation
- Investigators
- Edward B Diethrich, M.D., Principal investigator, Arizona Heart InstituteGrayson H Wheatley, M.D., Study director, Arizona Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271076
- Sponsor's protocol ID
- AHI # 1119
- Other IDs
- Volcano Therapeutics
- Status last verified
- Oct 2007
- First submitted
- 29 Dec 2005
- Last updated
- 25 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Plaque Intravascular Ultrasound Evaluation
- ClinicalTrials.gov ID
- NCT00271076
- Acronym / sponsor ID
- AHI # 1119
- Conditions
- Carotid Artery Disease
- Keywords
- CAD, CEA, CAS, IVUS, symptomatic, asymptomatic, Cerebral Protection Device, TIA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Arizona Heart InstituteUniversity, hospital or other
- Collaborators
- Volcano Corporation
- Study start
- Jan 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 30 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUS | Procedure or surgery | – |
| CAS | Device | – |
| CEA | Procedure or surgery | – |
Primary outcome
Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward B Diethrich, M.D. principal investigator
Arizona Heart Institute
Grayson H Wheatley, M.D. study director
Arizona Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IVUS, CAS and CEA in people with Carotid Artery Disease, run by Arizona Heart Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: the completion of plaque morphology assessment & correlation of in-vitro histology with in-vivo histology using the Eagle Eye Gold Catheter.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2007.