Carotid Artery DiseasePhase 3NCT00231231
Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
A Phase 3 study testing -PRECISE Nitinol Stent System (5F, 5.5F and 6F) and ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW) in people with Carotid Artery Disease, run by Cordis US Corp. at 1 site in United States.
Trial summary
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical Trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Disease
- What is being tested?
- -PRECISE Nitinol Stent System (5F, 5.5F and 6F) and ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Nov 2006
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be > 18 years of age.
- The patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as:
- one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or
- one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event), except as excluded below, with stenosis >50%, (as determined by ultrasound or angiogram) of the common or internal carotid artery, OR The patient must have a >80% diameter stenosis (as determined by ultrasound or angiogram) of the internal or common carotid artery without neurological symptoms.
- To be entered into the study, the patient must have one or more of the following conditions:
- congestive heart failure (class III/IV) and/or known severe left ventricular dysfunction LVEF < 30%
Show all 22Show fewer
- open heart surgery within six weeks
- recent MI (>24 hours and <4 weeks)
- unstable angina (CCS class III/IV)
- synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization
- severe pulmonary disease to include any of the following:
- <!-- -->
- chronic oxygen therapy
- resting PO2 of 60 mmHg
- baseline hematocrit 50%
- FEV1 or DLCO 50% of normal. · contralateral carotid occlusion · contralateral laryngeal palsy · post-radiation treatment · previous CEA recurrent stenosis · high cervical ICA lesions · CCA lesions below the clavicle · severe tandem lesions
- abnormal stress test.
- 4. The qualifying ultrasound or angiogram was performed less than 30 days prior to study entry.
- Stenosis >50%: PSV>130 cm/sec; EDV <135 cm/sec
- Stenosis >80%: PSV>220 cm/sec; EDV <135 cm/sec
- PSV ICA/PSV CCA ratio 4.0
- 5. The target vessel is in the native common or internal carotid artery. The arterial segment to be treated has a diameter between 4 mm and 9 mm as the largest diameter either proximal or distal to the lesion.
Who cannot join
- The patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours.
- There is any visual angiographic or ultrasound evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization.
- There is total occlusion of the target carotid artery treatment site.
- The reference segment diameter (distal common carotid and internal carotid artery segment cephalic to the lesion) is less than 4mm or greater than 9mm. See Instructions For Use, for proper stent sizing. The exception to this would be with a lesion having >95% stenosis where the true diameter of the distal vessel cannot be determined such as the case with a string sign or distal vessel collapse. In this case the judgment of the interventionalist will prevail with the intention not to oversize the stent to the distal vessel by more than 2mm.
- The patient has any intracranial aneurysm (> 9 mm).
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
- Conditions
- Carotid Artery Disease
- Being tested
- -PRECISE Nitinol Stent System (5F, 5.5F and 6F), ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
-PRECISE Nitinol Stent System (5F, 5.5F and 6F)Device
ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is a 30-day composite of major adverse clinical events (MAE) including any death, myocardial infarction, or stroke.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2004
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sidney A. Cohen, MD, PhD, Study director, Cordis US Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231231
- Sponsor's protocol ID
- P04-5204
- Status last verified
- Jul 2007
- First submitted
- 30 Sep 2005
- Last updated
- 20 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Katzen BT, Criado FJ, Ramee SR, Massop DW, Hopkins LN, Donohoe D, Cohen SA, Mauri L; CASES-PMS Investigators. Carotid artery stenting with emboli protection surveillance study: thirty-day results of the CASES-PMS study. Catheter Cardiovasc Interv. 2007 Aug 1;70(2):316-23. doi: 10.1002/ccd.21222.
PubMed 17630678Schreiber TL, Strickman N, Davis T, Kumar V, Mishkel G, Foster M, Donohoe D, Britto S, Ansel G; CASES-PMS Investigators. Carotid artery stenting with emboli protection surveillance study: outcomes at 1 year. J Am Coll Cardiol. 2010 Jun 29;56(1):49-57. doi: 10.1016/j.jacc.2010.02.045.
PubMed 20620717
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
- ClinicalTrials.gov ID
- NCT00231231
- Acronym / sponsor ID
- P04-5204
- Conditions
- Carotid Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Nov 2006 (actual)
- First posted
- 4 Oct 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.
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- The patient must be > 18 years of age.
- The patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as:
- To be entered into the study, the patient must have one or more of the following conditions:
- <!-- -->
- chronic oxygen therapy
Key exclusion criteria (5 listed)
- The patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours.
- There is any visual angiographic or ultrasound evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization.
- There is total occlusion of the target carotid artery treatment site.
- The reference segment diameter (distal common carotid and internal carotid artery segment cephalic to the lesion) is less than 4mm or greater than 9mm. See Instructions For Use, for proper stent sizing. The exception to this would be with a lesion having >95% stenosis where the true diameter of the distal vessel cannot be determined such as the case with a string sign or distal vessel collapse. In this case the judgment of the interventionalist will prevail with the intention not to oversize the stent to the distal vessel by more than 2mm.
- The patient has any intracranial aneurysm (> 9 mm).
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 |
|---|---|---|
| -PRECISE Nitinol Stent System (5F, 5.5F and 6F) | Device | – |
| ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW) | Device | – |
Primary outcome
The primary endpoint of this study is a 30-day composite of major adverse clinical events (MAE) including any death, myocardial infarction, or stroke.
Time frame: 30 day
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 20 Jul 2007.
- Results publication: PubMed 17630678Katzen BT, Criado FJ, Ramee SR, Massop DW, Hopkins LN, Donohoe D, Cohen SA, Mauri L; CASES-PMS Investigators. Carotid artery stenting with emboli protection surveillance study: thirty-day results of the CASES-PMS study. Catheter Cardiovasc Interv. 2007 Aug 1;70(2):316-23. doi: 10.1002/ccd.21222.
- Derived from this study: PubMed 20620717Schreiber TL, Strickman N, Davis T, Kumar V, Mishkel G, Foster M, Donohoe D, Britto S, Ansel G; CASES-PMS Investigators. Carotid artery stenting with emboli protection surveillance study: outcomes at 1 year. J Am Coll Cardiol. 2010 Jun 29;56(1):49-57. doi: 10.1016/j.jacc.2010.02.045.
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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.
Sidney A. Cohen, MD, PhD study director
Cordis US Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing -PRECISE Nitinol Stent System (5F, 5.5F and 6F) and ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW) in people with Carotid Artery Disease, run by Cordis US Corp. 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 22 inclusion and 5 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 20 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary endpoint of this study is a 30-day composite of major adverse clinical events (MAE) including any death, myocardial infarction, or stroke. (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00231231, which also lists 2 linked publications.
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 20 Jul 2007.