Clinical trial NCT01783639: Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
Official title: The WISE Study is a Pivotal Study Evaluating the Safety and Performance of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Diseases
Stroke
Keywords: Carotid
Carotid artery stenting
Stent
Embolic protection
Atherosclerotic Disease
Lead sponsor: Gardia Medical
Sponsor class: INDUSTRY
First posted: 2013-02-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.
timeFrame: Within 30 Days of procedure
Secondary outcomes:
measure: The Rate of Device Success
timeFrame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
measure: The Rate of Clinical Success
timeFrame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
measure: The Rate of Access Site Complications
timeFrame: Within 30 Days of procedure
measure: Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks
timeFrame: Within 30 Days of procedure
measure: Angiographic Success
timeFrame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
measure: Procedural Success
timeFrame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes
Other outcomes:
Locations:
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius Hospital, Department of Vascular Surgery
city: Bad-Krozingen
country: Germany
facility: Universitaets Herzzentrum
city: Berlin
country: Germany
facility: Ihre-Radiologen.de
city: Dortmund
country: Germany
facility: Klinikum Dortmund GmbH
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt
city: Hamburg
country: Germany
facility: Hamburg University Cardiovascular Center
city: Leipzig
country: Germany
facility: Herzzentrum and Park-Krankenhaus
city: Munich
country: Germany
facility: Städtisches Klinikum München GmbH Klinikum Neuperlach
city: Cotignola
country: Italy
facility: Villa Maria Cecilia Hospital
city: Mirano
country: Italy
facility: Mirano Hospital
Study officials:
affiliation: Herzzentrum Leipzig GmbH and Park-Krankenhaus Leipzig
name: Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardio Vascular Center Frankfurt
name: Horst Sievert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiologische Klinik, Klinikum Dortmund GmbH
name: Stefan Rohde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitäres Herz- und Gefäßzentrum Hamburg
name: Joachim Schofer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Städtisches Klinikum München GmbH
name: Harald Mudra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ St-Blasius, Dendermonde
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaets Herzzentrum, Bad-Krozingen
name: Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Villa Maria Cecilia, Contignola
name: Alberto Cremonesi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mirano Hospital
name: Bernhard Reimers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ihre-Radiologen.de
name: Henrik Schröder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.