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
  Purpose

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


Condition Intervention Phase
Carotid Artery Diseases
Stroke
Procedure: Carotid Artery Stent
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The WISE Study is a Pivotal Study Evaluating the Safety and Performance of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting

Resource links provided by NLM:


Further study details as provided by Gardia Medical:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 240
Study Start Date: February 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783639

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

No publications provided

Responsible Party: Gardia Medical
ClinicalTrials.gov Identifier: NCT01783639     History of Changes
Other Study ID Numbers: WIRION™ Pivotal Study (WISE), WIRION Study Europe (WISE)
Study First Received: January 13, 2013
Last Updated: March 9, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gardia Medical:
Carotid
Carotid artery stenting
Stent
Embolic protection
Atherosclerotic Disease

Additional relevant MeSH terms:
Carotid Artery Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014