The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Silk Road Medical
Sponsor:
Information provided by (Responsible Party):
Silk Road Medical
ClinicalTrials.gov Identifier:
NCT01958294
First received: October 4, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Carotid Stenosis
Carotid Artery Disease
Device: MICHI Neuroprotection System

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)

Resource links provided by NLM:


Further study details as provided by Silk Road Medical:

Primary Outcome Measures:
  • Composite of any stroke, myocardial infarction and death [ Time Frame: 30-days post-procedurally ] [ Designated as safety issue: Yes ]
    Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.


Secondary Outcome Measures:
  • Acute Device Success [ Time Frame: Intra procedural (1 day) ] [ Designated as safety issue: No ]
    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.

  • Procedural Success [ Time Frame: Through 30-day Follow-up period ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MICHI Neuroprotection System
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.
Device: MICHI Neuroprotection System
Other Names:
  • MICHI NPS
  • MICHI NPS + f

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
    • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958294

Contacts
Contact: Sumaira Macdonald, FRCP FRCR PhD EBIR 0191 2448457 sumaira.macdonald@nuth.nhs.uk

Locations
United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle upon Tyne, England, United Kingdom, NE7 7DN
Contact: Sumaira Macdonald       sumaira.macdonald@nuth.nhs.uk   
Principal Investigator: Sumaira Macdonald, FRCP FRCR PhD EBIR         
Sub-Investigator: Mike Wyatt, MB BS, MSc, FRCS         
Sub-Investigator: Mike Clarke, MB Ch.B, FRCS         
Sub-Investigator: David Lambert, BA MS BS FRCS         
Sub-Investigator: Tim Lees, MB CH.B FRCS         
Sub-Investigator: Lucy Wales, MB Ch.B FRCS PH.D         
Sub-Investigator: Gerard Stansby, BA, M.B.B. Chir, MA, FRCS         
Sub-Investigator: Ralph Jackson, MB BS, MRCP, FRCR         
Sub-Investigator: Rob Williams, MRCS, FRCR         
Sponsors and Collaborators
Silk Road Medical
Investigators
Principal Investigator: Sumaira Macdonald, FRCP FRCR PhD EBIR Newcastle upon Tyne Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Silk Road Medical
ClinicalTrials.gov Identifier: NCT01958294     History of Changes
Other Study ID Numbers: SRM-2011-01
Study First Received: October 4, 2013
Last Updated: October 4, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carotid Artery Diseases
Carotid Stenosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014