Carotid StenosisLOTUSNCT01958294
The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)
A study testing MICHI Neuroprotection System in people with Carotid Stenosis and Carotid Artery Disease, run by Silk Road Medical at 1 site in United Kingdom.
Trial summary
The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System (MICHI NPS) or MICHI Neuroprotection System with filter (MICHI NPS+f) for use in subjects who are candidates for Carotid Artery Stenting (CAS). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carotid Stenosis, Carotid Artery Disease
- What is being tested?
- MICHI Neuroprotection System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be > 21 years of age.
- Subject has the ability to understand and cooperate with study procedures and agrees to return for all required follow-up visits, tests, and exams.
- International Normalized Ratio (INR) must be ≤ 1.5 at the time of the procedure (subjects taking warfarin may be included if their dose is tapered prior to the procedure to meet the inclusion criterion. Dose may be returned to a therapeutic level after the procedure).
- The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local medical Ethics Committee (EC).
- The life expectancy of the subject is at least one year.
- The subject has a lesion located in the internal carotid artery (ICA); the carotid bifurcation may be involved.
- The subject must have a minimum distance of 5 cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound, computed axial tomographic (CT) angiography or magnetic resonance (MR) angiography.
Who cannot join
- The subject is participating in another investigational study that would interfere with the conduct or result of this study.
- The subject has dementia or a neurological illness that may confound the neurological evaluation.
- Presence of any one of the following anatomic risk factors:
- Previous radiation treatment to the neck or radical neck dissection
- Tracheostomy or tracheal stoma
- Laryngectomy
Show all 31Show fewer
- Contralateral laryngeal nerve palsy
- Severe tandem lesions
- Inability to extend the head due to cervical arthritis or other cervical disorders
- Total occlusion of the target vessel.
- There is an existing, previously placed stent in the target artery.
- The subject has a known life-threatening allergy to the contrast media that cannot be treated.
- Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), prasugrel heparin or bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and clopidogrel/ticlopidine or prasugrel.
- The subject has a gastrointestinal bleed that would interfere with antiplatelet therapy.
- The subject has known cardiac sources of emboli.
- Subject has Hemoglobin (Hgb) less than 8 gm/dL (unless on dialysis), platelet count < 50,000/mm3, or known heparin associated thrombocytopenia.
- Subject has documented atrial fibrillation in the prior 90 days.
- The subject has a history of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clotting time (ACT) at > 250, or if the subject will refuse blood transfusions.
- The subject has atherosclerotic disease involving the ipsilateral common carotid artery (CCA) that precludes safe placement of the sheath.
- The subject has abnormal angiographic findings other than that of the target lesion that indicate the subject is at risk for a stroke, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.
- There is evidence of a carotid artery dissection prior to the initiation of the procedure.
- There is an angiographically visible thrombus.
- There is any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure > 180 mm Hg, tortuosity, occlusive disease, vessel anatomy or aortic arch anatomy.
- Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
- There is evidence of bilateral carotid stenosis that would require intervention within 30 days of procedure.
- There is evidence of a major stroke (NIHSS ≥10) within the previous 30 days of the procedure or the patient is considered, by the investigator, to be at high risk for hemorrhagic stroke.
- There is a planned treatment of a non-target lesion within 30 days post procedure.
- There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke.
- There is history of an ipsilateral stroke with fluctuating neurologic symptoms within one year prior to the procedure.
- Female subjects who are pregnant (negative pregnancy test is required in women of childbearing potential).
- Subjects, who the Investigator determines, to be at risk of Deep Vein Thrombosis (DVT)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, England, NE7 7DN
About this study
The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System (MICHI NPS) or MICHI Neuroprotection System with filter (MICHI NPS+f) for use in subjects who are candidates for Carotid Artery Stenting (CAS). It is a prospective, single arm study in which a maximum of 30 study subjects, and a run-in enrollment of up to 10 subjects will be followed immediately post-op and at 30 days.
Read the detailed description
Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy (CEA). Many currently available embolic protection devices, however, have limited efficacy in capturing microembolic debris liberated during stenting, pre-dilatation and post-dilatation. Furthermore, distal protection systems are limited by the need to cross the lesion prior to deployment. Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed.
Cerebral protection with carotid flow reversal is a method that was developed by Parodi, et al. (2005), as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Criado, et al. (2004), developed a derivative technique that employs carotid flow reversal prior to traversing the stenosis that can be accomplished by directly accessing carotid anatomy without the use of the transfemoral approach. Major benefits to this method include the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.
- Conditions
- Carotid Stenosis, Carotid Artery Disease
- Being tested
- MICHI Neuroprotection System
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICHI Neuroprotection SystemDevice
Also called MICHI NPS, MICHI NPS + f
| Study group | Role | What they receive |
|---|---|---|
| MICHI Neuroprotection System | Other | Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System. Receives: Device: MICHI Neuroprotection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Any Stroke, Myocardial Infarction and Death
Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.
Measured: 30-days post-procedurally
Secondary outcomes (2)
Acute Device Success
Acute device success - Defined as MICHI™ NPS was delivered (vascular access achieved), reverse flow was attempted and established and the device retrieved / removed from vasculature.
Measured: Intra procedural (1 day)
Procedural Success
Procedure Success - Procedural success is the ability to deliver therapeutic devices (balloons, stents, etc.) through the Transcervical Arterial Sheath and the ability to provide embolic protection throughout the procedure with the freedom of device related Major Adverse Events at 30 days.
Measured: Through 30-day Follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startAug 2011
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carotid StenosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Road Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sumaira Macdonald, FRCP FRCR PhD EBIR, Principal investigator, Newcastle upon Tyne Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958294
- Sponsor's protocol ID
- SRM-2011-01
- Acronym
- LOTUS
- Status last verified
- Mar 2019
- First submitted
- 4 Oct 2013
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)
- ClinicalTrials.gov ID
- NCT01958294
- Acronym / sponsor ID
- LOTUS / SRM-2011-01
- Conditions
- Carotid Stenosis, Carotid Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Silk Road MedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System (MICHI NPS) or MICHI Neuroprotection System with filter (MICHI NPS+f) for use in subjects who are candidates for Carotid Artery Stenting (CAS). It is a prospective, single arm study in which a maximum of 30 study subjects, and a run-in enrollment of up to 10 subjects will be followed immediately post-op and at 30 days.
Detailed description
Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy (CEA). Many currently available embolic protection devices, however, have limited efficacy in capturing microembolic debris liberated during stenting, pre-dilatation and post-dilatation. Furthermore, distal protection systems are limited by the need to cross the lesion prior to deployment. Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed.
Cerebral protection with carotid flow reversal is a method that was developed by Parodi, et al. (2005), as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Criado, et al. (2004), developed a derivative technique that employs carotid flow reversal prior to traversing the stenosis that can be accomplished by directly accessing carotid anatomy without the use of the transfemoral approach. Major benefits to this method include the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MICHI Neuroprotection System | Other | Device: MICHI Neuroprotection SystemSubjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be > 21 years of age.
- Subject has the ability to understand and cooperate with study procedures and agrees to return for all required follow-up visits, tests, and exams.
- International Normalized Ratio (INR) must be ≤ 1.5 at the time of the procedure (subjects taking warfarin may be included if their dose is tapered prior to the procedure to meet the inclusion criterion. Dose may be returned to a therapeutic level after the procedure).
- The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local medical Ethics Committee (EC).
- The life expectancy of the subject is at least one year.
Key exclusion criteria (31 listed)
- The subject is participating in another investigational study that would interfere with the conduct or result of this study.
- The subject has dementia or a neurological illness that may confound the neurological evaluation.
- Presence of any one of the following anatomic risk factors:
- Total occlusion of the target vessel.
- There is an existing, previously placed stent in the target artery.
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 |
|---|---|---|
| MICHI Neuroprotection SystemAlso: MICHI NPS, MICHI NPS + f | Device | MICHI Neuroprotection System |
Primary outcome
Composite of Any Stroke, Myocardial Infarction and Death
Time frame: 30-days post-procedurally
Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.
2 secondary outcomes
Acute Device Success
Time frame: Intra procedural (1 day)
Procedural Success
Time frame: Through 30-day Follow-up period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sumaira Macdonald, FRCP FRCR PhD EBIR principal investigator
Newcastle upon Tyne Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MICHI Neuroprotection System in people with Carotid Stenosis and Carotid Artery Disease, run by Silk Road Medical at 1 site in United Kingdom.
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 7 inclusion and 31 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 18 Jan 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 Kingdom. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite of Any Stroke, Myocardial Infarction and Death (time frame: 30-days post-procedurally). 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 18 Jan 2020.