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

Not Applicable

Completed

• Conditions: Stroke; Carotid Artery Diseases
• Interventions: Procedure: Carotid Artery Stent

• Registration Number: NCT01783639
• Lead Sponsor: Gardia Medical

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-01-13
• Study Start: 2013-02
• Study First Submitted QC: 2013-02-01
• Study First Posted: 2013-02-05
• Primary Completion: 2013-12
• Study Completion: 2015-04
• Results First Submitted: 2015-06-08
• Results First Submitted QC: 2015-06-24
• Results First Posted: 2015-07-22
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Carotid Artery Stent	Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent

Primary Outcome Measures

Name	Time	Method
The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.	Within 30 Days of procedure	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.

Secondary Outcome Measures

Name	Time	Method
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	Participants will be followed for the duration of the procedure, an expected average of 35 minutes	Successful completion of the protected stent procedure without angiographic complications
Procedural Success	Participants will be followed for the duration of the procedure, an expected average of 35 minutes	Defined as both device and angiographic success
The Rate of Device Success	Participants will be followed for the duration of the procedure, an expected average of 35 minutes	Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications
The Rate of Clinical Success	Participants will be followed for the duration of the procedure, an expected average of 35 minutes	Defined as freedom from procedure related serious adverse events

Trial Locations

Locations (10)

AZ Sint Blasius Hospital, Department of Vascular Surgery; 🇧🇪 Dendermonde, Belgium

Universitaets Herzzentrum; 🇩🇪 Bad-Krozingen, Germany

Ihre-Radiologen.de; 🇩🇪 Berlin, Germany

CardioVascular Center Frankfurt; 🇩🇪 Frankfurt, Germany

Klinikum Dortmund GmbH; 🇩🇪 Dortmund, Germany

Hamburg University Cardiovascular Center; 🇩🇪 Hamburg, Germany

Städtisches Klinikum München GmbH Klinikum Neuperlach; 🇩🇪 Munich, Germany

Herzzentrum and Park-Krankenhaus; 🇩🇪 Leipzig, Germany

Villa Maria Cecilia Hospital; 🇮🇹 Cotignola, Italy

Mirano Hospital; 🇮🇹 Mirano, Italy