Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting (WISE)

The WISE Study is a Pivotal Study Evaluating the Safety and Performance of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting

The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with embolic protection studies

Study Overview

• Status: Completed
• Conditions: Stroke; Carotid Artery Diseases
• Intervention / Treatment: Procedure: Carotid Artery Stent

Detailed Description

Patient registry procedures include:

• Clinical Events Committee (CEC); responsibility for validating all reported primary safety outcomes
• Data Safety Monitoring Board (DSMB); to review and evaluate safety data including serious adverse events
• 100% data monitoring; to compare data entered into the registry
• Source data verification; to assess the accuracy, completeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).
• Standard Operating Procedures; to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis and reporting for adverse events.
• Sample size assessment to specify the number of participants and follow up duration.
• Data Management Plan; to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
• Statistical analysis plan; describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Dendermonde, Belgium, 9200
    • AZ Sint Blasius Hospital, Department of Vascular Surgery
• Germany
  • Bad-Krozingen, Germany, 79189
    • Universitaets Herzzentrum
  • Berlin, Germany, 13347
    • Ihre-Radiologen.de
  • Dortmund, Germany, 44137
    • Klinikum Dortmund GmbH
  • Frankfurt, Germany, 60389
    • Cardiovascular Center Frankfurt
  • Hamburg, Germany, 22527
    • Hamburg University Cardiovascular Center
  • Leipzig, Germany, 04289
    • Herzzentrum and Park-Krankenhaus
  • Munich, Germany, 87137
    • Städtisches Klinikum München GmbH Klinikum Neuperlach
• Italy
  • Cotignola, Italy, 48010
    • Villa Maria Cecilia Hospital
  • Mirano, Italy, 30035
    • Mirano Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age
• Anticipated patient life expectancy of at least 1 year
• Patient or authorized representative, signed a written Informed Consent form
• Patient is willing to comply with the protocol requirements
• Candidate for catheter-based therapy of a single stenosis located in the internal carotid artery (ICA) or the carotid bifurcation, suitable for treatment with a single FDA-approved stent with a carotid use indication
• Reference vessel diameter for intended filter location between 3.5mm and 6.0mm
• An adequate "landing zone" of at least 30mm
• Patients with severe symptomatic or asymptomatic carotid artery stenosis, to be ≥ 50% for symptomatic patients OR ≥ 80% for asymptomatic patients
• At least one high surgical risk criteria, either anatomical or co-morbid risk factors, as listed below:

Category I - Anatomical high risk factors

• Recurrent stenosis after endarterectomy
• Previous radical neck surgery or radiation therapy to the neck
• High cervical ICA lesions or CCA lesions at or above C2 or below the clavicle
• Spinal immobility of the neck
• Tracheostomy or tracheal stoma
• Any laryngeal nerve palsy and bilateral carotid artery stenosis

Category II - Co-morbid risk factors

• Contralateral carotid occlusion
• Unstable angina (Canadian Cardiovascular Society class III/IV)
• Congestive Heart Failure (New York Heart Association functional class III/IV) and/or known severe left ventricular dysfunction LVEF<30%
• Requires coronary artery bypass surgery, cardiac valve surgery, major vascular surgery, or abdominal aortic aneurysm repair 31-60 days post carotid stent procedure
• Recent MI (>72 hr and <4 weeks)
• Severe pulmonary disease with FEV1 of <30%
• CAD in ≥2 unrevascularized vessels with stenosis ≥70%
• Age ≥75 years
• Uncontrolled diabetes - Female patient with no child bearing potential or has negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study

Exclusion Criteria:

• Total occlusion or near-occlusion of the target vessel
• Severe lesion calcification
• Presence of an alternate source of emboli
• Presence of a filling defect, or angiographically visible thrombus, at target site
• A greater than 50% CCA lesion proximal to the target or a distal (intracranial) lesion more severe than the target lesion
• Evolving, acute or recent stroke within the last 30 days
• Major stroke with a residual neurological deficit that would confound neurologic assessment
• Vertebrobasilar insufficiency symptoms only
• Major operation 30 days before or after the index procedure
• Ipsilateral intracranial stenosis that requires treatment
• Any pre-existing stent in ipsilateral carotid artery, or placement of a stent in contralateral carotid within 30 days of the index procedure
• History of intracranial hemorrhage within 12 months
• Any condition that precludes proper angiographic assessment or prevents femoral arterial access
• Uncontrolled hypertension
• Contraindication to heparin and bivalirudin, aspirin, thienopyridines
• Known sensitivity to radiographic contrast media which cannot be controlled with pre-medication
• History or current indication of bleeding diathesis or coagulopathy
• Chronic renal insufficiency
• Carotid artery dissection or aortic arch anatomical anomalies
• Dementia or a neurological illness
• Patient is enrolled in another drug or device study protocol that has not reached its primary endpoint
• Severe pulmonary hypertension
• Intra-cranial pathology (e.g., tumor, AVM. aneurysm, etc) that would make study participation inappropriate or confound neurologic assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent	Procedure: Carotid Artery Stent; Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.	Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.	Within 30 Days of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of Device Success	Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications	Participants will be followed for the duration of the procedure, an expected average of 35 minutes
The Rate of Clinical Success	Defined as freedom from procedure related serious adverse events	Participants will be followed for the duration of the procedure, an expected average of 35 minutes
The Rate of Access Site Complications		Within 30 Days of procedure
Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks		Within 30 Days of procedure
Angiographic Success	Successful completion of the protected stent procedure without angiographic complications	Participants will be followed for the duration of the procedure, an expected average of 35 minutes
Procedural Success	Defined as both device and angiographic success	Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Collaborators and Investigators

• Sponsor: Gardia Medical
• Investigators: Principal Investigator: Dierk Scheinert, MD, Herzzentrum Leipzig GmbH and Park-Krankenhaus Leipzig; Principal Investigator: Horst Sievert, MD, Cardio Vascular Center Frankfurt; Principal Investigator: Stefan Rohde, MD, Radiologische Klinik, Klinikum Dortmund GmbH; Principal Investigator: Joachim Schofer, MD, Universitäres Herz- und Gefäßzentrum Hamburg; Principal Investigator: Harald Mudra, MD, Städtisches Klinikum München GmbH; Principal Investigator: Marc Bosiers, MD, AZ St-Blasius, Dendermonde; Principal Investigator: Thomas Zeller, MD, Universitaets Herzzentrum, Bad-Krozingen; Principal Investigator: Alberto Cremonesi, MD, Villa Maria Cecilia, Contignola; Principal Investigator: Bernhard Reimers, MD, Mirano Hospital; Principal Investigator: Henrik Schröder, MD, Ihre-Radiologen.de

Publications and helpful links

General Publications

• Scheinert D, Reimers B, Cremonesi A, Schmidt A, Sievert H, Rohde S, Schofer J, Mudra HG, Bosiers M, Zeller T, Pacchioni A, Rosenschein U; WISE (Wirion Study Europe) Pivotal Trial Investigators. Independent Modular Filter for Embolic Protection in Carotid Stenting. Circ Cardiovasc Interv. 2017 Mar;10(3):e004244. doi: 10.1161/CIRCINTERVENTIONS.116.004244.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 13, 2013
• First Submitted That Met QC Criteria: February 1, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Stent; Carotid; Carotid artery stenting; Embolic protection; Atherosclerotic Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carotid Artery Diseases
• Other Study ID Numbers: WIRION™ Pivotal Study (WISE); WIRION Study Europe (WISE) (Other Identifier: Gardia Medical Ltd.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No