Carotid Artery DiseasePhase 2COBRANCT00812383
Carotid With Bivalirudin Angioplasty
A Phase 2 study testing RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System in people with Carotid Artery Disease, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
Single center randomized clinical trial, to evaluate the safety and efficacy of carotid artery stenting using the RX ACCULINK™ Carotid Stent System with RX ACCUNET™ Embolic Protection System or PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System using Angiomax (bivalirudin)versus heparin as the… 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?
- RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Dec 2019
- Phase
- Phase 2
- 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
- The patient must be at least 18 years of age.
- The patient must have a significant diameter reduction of the extracranial or intracranial internal or common carotid artery, defined as ≥50% stenosis for symptomatic patients or ≥80% stenosis for asymptomatic patients determined by carotid duplex ultrasound scan and/or carotid angiography.
- Female patients with child bearing potential must have a negative pregnancy test.
- The patient and the patient's physician must agree to have the patient return for a 30-day and one-year clinical and ultrasound imaging follow-up evaluations as indicated in the protocol.
- Reference vessel diameter ≥ 3.5 mm - ≤ 9.0 mm diameter.
Who cannot join
- The patient has had a recent (<4 weeks) disabling stroke or dementia with major neurologic deficit (stroke scales: Barthel <60, NIH >15, or Rankin >3) at pre-procedure neuro exam.
- The patient has had within four weeks of the treatment procedure an intracranial hemorrhage, hemorrhage stroke, major stroke, or any stroke with mass effect demonstrated on MRI or CT.
- The patient has a known allergy to heparin, bivalirudin, aspirin or to anti-platelet agents that prevents taking aspirin plus ticlopidine or aspirin plus clopidogrel.
- The patient has received fractionated or unfractionated heparin within 8 hours prior to the procedure.
- The patient has a history of prior life-threatening radiocontrast reaction that cannot be pre-treated.
- The patient has a history of bleeding diathesis or coagulopathy within 3 months.
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- The patient is currently participating in another study protocol that may influence either procedure results or follow-up evaluations.
- Plasma/serum creatinine > 3.0 mg/dl at time of intervention.
- Hemodynamic instability at the time of intervention.
- Previous stent placement in the ipsilateral carotid distribution.
- Angiographic Exclusion Criteria
- The patient has an intracranial tumor, or cerebral arterio-venous malformation(s) > 5mm, aneurysms or severe intracranial stenosis distal to target lesion.
- The patient has inaccessible intracranial arterial stenosis greater in severity than the extracranial internal carotid artery lesion.
- There is angiographic evidence of significant intra-luminal thrombus burden with presumed increased risk of plaque fragmentation and consequent distal embolization.
- There is total occlusion of the ipsilateral carotid artery treatment site with TIMI 0 flow characteristics.
- The reference segment diameter (internal carotid artery segment cephalad to the lesion) is less than 3 millimeters by operator visual estimate.
- The patient has peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding use of catheter-based techniques required for successful CSSA
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Single center randomized clinical trial, to evaluate the safety and efficacy of carotid artery stenting using the RX ACCULINK™ Carotid Stent System with RX ACCUNET™ Embolic Protection System or PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System using Angiomax (bivalirudin)versus heparin as the anticoagulant for treatment of occlusive carotid artery disease in low and high risk patient cohorts.
- Conditions
- Carotid Artery Disease
- Being tested
- RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System
- 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.
RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration SystemDevice
Angiomax (bivalirudin) versus standard anticoagulation with heparin during carotid artery stenting with distal protection clinical endpoint evaluation
| Study group | Role | What they receive |
|---|---|---|
| Bivalirudin | Experimental | Not described Receives: Device: RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System |
| Heparin | Active comparator | Not described Receives: Device: RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate clinical success (<50% residual stenosis at all treatment sites without death, myocardial infarction, stroke or major bleed)
Measured: 30 days
Secondary outcomes (2)
To assess for complications including death, myocardial infarction, major or minor stroke, major or minor bleeding, and vascular complications.
Measured: In hospital and 30 days
To assess stent patency , and occurence of death or recurrent neurological events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startAug 2003
- Primary completionJul 2019
- Study completionDec 2019
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lowell Satler, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812383
- Sponsor's protocol ID
- COBRA
- Acronym
- COBRA
- Status last verified
- Oct 2020
- First submitted
- 18 Dec 2008
- Last updated
- 28 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid With Bivalirudin Angioplasty
- ClinicalTrials.gov ID
- NCT00812383
- Acronym / sponsor ID
- COBRA / COBRA
- Conditions
- Carotid Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Aug 2003 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 22 Dec 2008 (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.
Single center randomized clinical trial, to evaluate the safety and efficacy of carotid artery stenting using the RX ACCULINK™ Carotid Stent System with RX ACCUNET™ Embolic Protection System or PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System using Angiomax (bivalirudin)versus heparin as the anticoagulant for treatment of occlusive carotid artery disease in low and high risk patient cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalirudin | Experimental | Device: RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System |
| Heparin | Active comparator | Device: RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must be at least 18 years of age.
- The patient must have a significant diameter reduction of the extracranial or intracranial internal or common carotid artery, defined as ≥50% stenosis for symptomatic patients or ≥80% stenosis for asymptomatic patients determined by carotid duplex ultrasound scan and/or carotid angiography.
- Female patients with child bearing potential must have a negative pregnancy test.
- The patient and the patient's physician must agree to have the patient return for a 30-day and one-year clinical and ultrasound imaging follow-up evaluations as indicated in the protocol.
- Reference vessel diameter ≥ 3.5 mm - ≤ 9.0 mm diameter.
Key exclusion criteria (17 listed)
- The patient has had a recent (<4 weeks) disabling stroke or dementia with major neurologic deficit (stroke scales: Barthel <60, NIH >15, or Rankin >3) at pre-procedure neuro exam.
- The patient has had within four weeks of the treatment procedure an intracranial hemorrhage, hemorrhage stroke, major stroke, or any stroke with mass effect demonstrated on MRI or CT.
- The patient has a known allergy to heparin, bivalirudin, aspirin or to anti-platelet agents that prevents taking aspirin plus ticlopidine or aspirin plus clopidogrel.
- The patient has received fractionated or unfractionated heparin within 8 hours prior to the procedure.
- The patient has a history of prior life-threatening radiocontrast reaction that cannot be pre-treated.
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 |
|---|---|---|
| RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration SystemAngiomax (bivalirudin) versus standard anticoagulation with heparin during carotid artery stenting with distal protection clinical endpoint evaluation | Device | Bivalirudin, Heparin |
Primary outcome
To evaluate clinical success (<50% residual stenosis at all treatment sites without death, myocardial infarction, stroke or major bleed)
Time frame: 30 days
2 secondary outcomes
To assess for complications including death, myocardial infarction, major or minor stroke, major or minor bleeding, and vascular complications.
Time frame: In hospital and 30 days
To assess stent patency , and occurence of death or recurrent neurological events
Time frame: 12 months
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 28 Oct 2020.
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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.
Lowell Satler, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System in people with Carotid Artery Disease, run by Medstar Health Research 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 5 inclusion and 17 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 28 Oct 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate clinical success (<50% residual stenosis at all treatment sites without death, myocardial infarction, stroke or major bleed) (time frame: 30 days). 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 28 Oct 2020.