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

NCT01958294 | Completed Results DMC

• 1 other identifier: SRM-2011-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Carotid Stenosis; Carotid Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  30-days post-procedurally

Secondary Outcomes (2)

• Acute Device Success

  Intra procedural (1 day)

• Procedural Success

  Through 30-day Follow-up period

Study Arms (1)

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.

Device: MICHI Neuroprotection System

Interventions

MICHI Neuroprotection System DEVICE

Also known as: MICHI NPS, MICHI NPS + f

MICHI Neuroprotection System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silk Road Medical: lead

Study Sites (1)

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ric Ruedy, Exec VP, Clinical Affairs
• Organization: Silk Road Medical, Inc.

ric@silkroadmed.com

408-585-2112

Study Officials

• Sumaira Macdonald, FRCP FRCR PhD EBIR

  Newcastle upon Tyne Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 9, 2013
• Study Start: August 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2019-03

Locations

GB (1)