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

NCT01783639 | Completed Results DMC

• 2 other identifiers: WIRION™ Pivotal Study (WISE)WIRION Study Europe (WISE)
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 10

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

Conditions

Carotid Artery Diseases; Stroke

Keywords

Carotid; Carotid artery stenting; Stent; Embolic protection; Atherosclerotic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The Rate of Device Success

  Participants will be followed for the duration of the procedure, an expected average of 35 minutes

• The Rate of Clinical Success

  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

  Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Study Arms (1)

Arm 1

EXPERIMENTAL

Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent

Procedure: Carotid Artery Stent

Interventions

Carotid Artery Stent PROCEDURE

Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gardia Medical: lead

Study Sites (10)

AZ Sint Blasius Hospital, Department of Vascular Surgery

Dendermonde, 9200, Belgium

Location

Universitaets Herzzentrum

Bad Krozingen, 79189, Germany

Location

Ihre-Radiologen.de

Berlin, 13347, Germany

Location

Klinikum Dortmund GmbH

Dortmund, 44137, Germany

Location

CardioVascular Center Frankfurt

Frankfurt, 60389, Germany

Location

Hamburg University Cardiovascular Center

Hamburg, 22527, Germany

Location

Herzzentrum and Park-Krankenhaus

Leipzig, 04289, Germany

Location

Städtisches Klinikum München GmbH Klinikum Neuperlach

Munich, 87137, Germany

Location

Villa Maria Cecilia Hospital

Cotignola, 48010, Italy

Location

Mirano Hospital

Mirano, 30035, Italy

Location

Related Publications (1)

• 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.

  PMID: 28283511 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Vardit Segal
• Organization: Gardia Medical

Vardit@Gardiamedical.com

+972-4-6277166

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2013
• First Posted: February 5, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2015
• Last Updated: August 7, 2017
• Results First Posted: July 22, 2015

Record last verified: 2017-06

Locations

IT (2); DE (7); BE (1)