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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gardia Medical
ClinicalTrials.gov Identifier:
NCT01783639
First received: January 13, 2013
Last updated: March 9, 2014
Last verified: March 2014

January 13, 2013
March 9, 2014
February 2013
April 2014   (final data collection date for primary outcome measure)
The rate of peri-procedural (within 30 days of procedure) death, stroke, and myocardial infarction. [ Time Frame: Within 30 Days of procedure ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01783639 on ClinicalTrials.gov Archive Site
  • The rate of Device Success [ Time Frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes ] [ Designated as safety issue: Yes ]
    Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications
  • The rate of Clinical Success [ Time Frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes ] [ Designated as safety issue: Yes ]
    Defined as freedom from procedure related serious adverse events
  • The rate of Access site complications [ Time Frame: Within 30 Days of procedure ] [ Designated as safety issue: Yes ]
  • Neurological events occurring within 30 days post procedure,including strokes and transient ischemic attacks [ Time Frame: Within 30 Days of procedure ] [ Designated as safety issue: Yes ]
  • Angiographic Success [ Time Frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes ] [ Designated as safety issue: Yes ]
    Successful completion of the protected stent procedure without angiographic complications
  • Procedural Success [ Time Frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes ] [ Designated as safety issue: Yes ]
    Defined as both device and angiographic success
Same as current
Not Provided
Not Provided
 
Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
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

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.
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Carotid Artery Diseases
  • Stroke
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
Experimental: Arm 1

Device: WIRION™ Embolic Protection System

Interventions: Carotid Artery Stent

Intervention: Procedure: Carotid Artery Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
April 2015
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Italy
 
NCT01783639
WIRION™ Pivotal Study (WISE), WIRION Study Europe (WISE)
Yes
Gardia Medical
Gardia Medical
Not Provided
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
Gardia Medical
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP