Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure

NCT01685567 | Completed Phase 3 Results DMC

• 1 other identifier: SRM-2012-02
• Study Type: interventional
• Target: 219
• Locations: 2 countries
• Sites: 21

Brief Summary

The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in carotid arteries. The MICHI NPS+f also facilitates access to the carotid and neuro anatomy for the introduction of therapeutic or diagnostic endovascular devices and/or agents. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.

Conditions

Carotid Artery Disease

Keywords

carotid artery disease; reverse flow

Outcome Measures

Primary Outcomes (1)

• Hierarchical Composite of Stroke, Myocardial Infarction, and Death

  The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.

  30-day post-procedure

Secondary Outcomes (4)

• All Death (Non-hierarchical)

  0 to 30 days

• All Myocardial Infarctions (Non-hierarchical)

  0 to 30 days

• All Stroke (Non-hierarchical)

  0 to 30 days

• Ipsilateral Stroke (Non-hierarchical)

  31-365 days

Study Arms (1)

MICHI NPS+f

EXPERIMENTAL

The MICHI™ NPS+f is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify to the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.

Device: MICHI NPS+f

Interventions

MICHI NPS+f DEVICE

Cerebral protection with carotid flow reversal

Also known as: ENROUTE Transcarotid Neuroprotection System

MICHI NPS+f

Eligibility Criteria

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

You may qualify if:

• Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
• Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure.
• Asymptomatic: Stenosis must be greater than or equal to 70% as determined by angiogram without any neurological symptoms within the prior 180 days.
• Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements).
• Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
• Patient is greater or equal to 18 years of age.
• Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.
• Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.
• Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
• Patient meets at least one of the anatomic or clinical high-risk criteria.

You may not qualify if:

• Patient has chronic atrial fibrillation.
• Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
• Patient has an evolving stroke.
• Patient has severe dementia.
• Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
• Patient has had a recent (\<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.
• Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
• Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusion.
• Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.
• Patient has had a recent GI bleed that would interfere with antiplatelet therapy.
• Life expectancy of \< 12 months post procedure.
• Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, prasugrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine, ASA and clopidogrel or ASA and prasugrel.
• Myocardial Infarction within 72 hours prior to the intervention.
• Presence of a previous placed intravascular stent in target vessel or the planned arteriotomy site.
• Patient has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke (e.g. partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, moderate to severe dementia, or intracranial hemorrhage).

Sponsors & Collaborators

• Silk Road Medical: lead

Study Sites (21)

Peter Morton UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Florida Hospital

Orlando, Florida, 32804, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109-5967, United States

Location

McLaren Regional Medical Center

Flint, Michigan, 48507, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

University at Buffalo Neurosurgery, Inc

Buffalo, New York, 14203, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44106, United States

Location

University Hospitals Case Medical Center and Case Western Reserve University School of Medicine

Cleveland, Ohio, 44106, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

Oklahoma Heart

Oklahoma City, Oklahoma, 73120, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29615, United States

Location

Cardiothoracic & Vascular Surgeons

Austin, Texas, 78756, United States

Location

Methodist Medical Center

Dallas, Texas, 75208, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Related Publications (4)

• Kwolek CJ, Jaff MR, Leal JI, Hopkins LN, Shah RM, Hanover TM, Macdonald S, Cambria RP. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015 Nov;62(5):1227-34. doi: 10.1016/j.jvs.2015.04.460.

  PMID: 26506270 RESULT

• Alpaslan A, Wintermark M, Pinter L, Macdonald S, Ruedy R, Kolvenbach R. Transcarotid Artery Revascularization With Flow Reversal. J Endovasc Ther. 2017 Apr;24(2):265-270. doi: 10.1177/1526602817693607. Epub 2017 Feb 17.

  PMID: 28335706 RESULT

• Chung J, Kumins NH, Smith J, Motaganahalli RL, Schneider PA, Kwolek CJ, Kashyap VS; ROADSTER Investigators. Physiologic risk factors increase risk of myocardial infarction with transcarotid artery revascularization in prospective trials. J Vasc Surg. 2023 Apr;77(4):1192-1198. doi: 10.1016/j.jvs.2022.12.013. Epub 2022 Dec 20.

  PMID: 36563712 DERIVED

• Malas MB, Leal Lorenzo JI, Nejim B, Hanover TM, Mehta M, Kashyap V, Kwolek CJ, Cambria R. Analysis of the ROADSTER pivotal and extended-access cohorts shows excellent 1-year durability of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2019 Jun;69(6):1786-1796. doi: 10.1016/j.jvs.2018.08.179. Epub 2019 Jan 2.

  PMID: 30611582 DERIVED

Related Links

• Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal.
• Transcarotid Artery Revascularization with Flow Reversal: the PROOF Study

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Linda Ruedy. Sr. Director, Clinical and Regulatory Affairs
• Organization: Silk Road Medical, Inc.

lruedy@silkroadmed.com

(408) 585-2113

Study Officials

• Christopher Kwolek, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Richard Cambria, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 14, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 7, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-06

Locations

ES (1); US (20)