Trial record 2 of 8 for:    WINGSPAN

Post Market Surveillance Study of the Wingspan Stent System (WEAVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Stryker Neurovascular
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT02034058
First received: January 9, 2014
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

The primary objective of this study is to evaluate the rate of stroke and/or death in patients treated with the Wingspan Stent System, according to the Indications for Use, within 72 hours post procedure.


Condition Intervention
Intracranial Atherosclerosis
Device: Wingspan Stent System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study

Resource links provided by NLM:


Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Stroke or Death [ Time Frame: within 72 hours of the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ischemic Stroke [ Time Frame: within 72 hours post procedure ] [ Designated as safety issue: No ]
  • Neurological Death [ Time Frame: within 72 hours post procedure ] [ Designated as safety issue: Yes ]
  • Stroke recovery [ Time Frame: at 90 days post procedure ] [ Designated as safety issue: Yes ]
  • Stroke in the territory of the stented artery [ Time Frame: within 72 hours post procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 389
Study Start Date: December 2013
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Wingspan Stent System
Placement of the Wingspan Stent
Device: Wingspan Stent System
The Wingspan Stent System is used with the Gateway PTA Balloon Catheter. The Wingspan Stent System is a self-expanding, Nitinol stent and delivery system intended for use in the treatment of intracranial atherosclerotic disease. The Gateway PTA Balloon Catheter is an over-the-wire balloon catheter intended for the pre-dilation of the lesion prior to insertion and deployment of the Wingspan Stent System.

Detailed Description:

This research study is a Food and Drug Administration (FDA) mandated post market surveillance study of the Wingspan® Stent System, also known as the WEAVE™ Trial. The purpose of this trial is to fulfill a FDA requirement to evaluate the rate of stroke and/or death within 72 hours of the procedure, in patients who have a Wingspan Stent implanted in accordance with the Indications for Use.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

All patients for whom treatment with the Wingspan Stent System is considered.

  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: NCT02034058

Contacts
Contact: Lisha Capucion 510-413-2584 Lisha.Capucion@Stryker.com
Contact: Lani Faulkner 510-413-2719 Lani.Faulkner@Stryker.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Vicki Manoukian, MA    310-423-5067    vicki.manoukian@cshs.org   
Principal Investigator: Michael Alexander, MD         
Southern California Permanente Medical Group Recruiting
Los Angeles, California, United States, 90027
Contact: Usha Vaghasia, BA    626-564-3128    Usha.G.Vaghasia@kp.org   
Contact: Raymond Kim    323-783-6698    Raymond.W.Kim@kp.org   
Principal Investigator: Lei Feng, MD         
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93105
Contact: Sharon Granoff, BSN    805-569-7461    sgranoff@sbch.org   
Contact: Laura Isaacs    805-569-7461    lisaacs@sbch.org   
Principal Investigator: Alois Zauner, MD         
United States, Florida
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Nancy Cabrera, CCRP    305-674-2163    Nancy.Cabrera@msmc.com   
Principal Investigator: John Chaloupka, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Christy Anton    312-942-1489    Christy_Anton@rush.edu   
Contact: Michelle Smreczak    312-942-8614    Michelle_L_Smreczak@rush.edu   
Principal Investigator: Demetrius Lopes, MD         
Advocate Health System Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Gina Littlejohn, RN    847-723-2099    gina.littlejohn@advocatehealth.com   
Contact: Diane Lelo, RN    847-723-7391    diane.lelo@advocatehealth.com   
Principal Investigator: Thomas Grobelny, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Linda Breathitt, RN    859-260-6100    Lbreathitt@bhsi.com   
Contact: Sara Birk, CRC    859-260-6100    sara.birk1@bhsi.com   
Principal Investigator: Curtis Given, MD         
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Linda McCown    859-323-1823    linda.mccown@uky.edu   
Principal Investigator: Abdulnasser Alhajeri, MD         
Principal Investigator: Justin Fraser, MD         
United States, Massachusetts
University of Massachusetts, Worcester Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Mary Howk    774-441-8442    Mary.Howk@umassmed.edu   
Principal Investigator: Ajit Puri, MD         
United States, Missouri
SSM DePaul Health Center Recruiting
Bridgeton, Missouri, United States, 63044
Contact: Michelle Raymond, RN    314-344-6000    Michelle_Raymond@ssmhc.com   
Principal Investigator: Richard Callison, MD         
SSM St. Clare Health Center Recruiting
Fenton, Missouri, United States, 63026
Contact: Sue Ellen Theis, RN, BSN    636-487-1153    Sue_Theis@ssmhc.com   
Contact: Jill Blasdel    636-496-3900    Jill_Blasdel@ssmhc.com   
Principal Investigator: Armond Levy, MD         
United States, New Jersey
Capital Health Systems Recruiting
Trenton, New Jersey, United States, 08638
Contact: Cynthia Lewis-Diaz, RN, MHA    609-394-6287    CDiaz@capitalhealth.org   
Contact: Alison Rudolf    215-850-0258    arudolf@capitalheatlh.org   
Principal Investigator: Erol Veznedaroglu, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Amy Richmond    216-444-9524    richmoa@ccf.org   
Contact: Jennifer Turczyk    216-445-4488    turczyj@ccf.org   
Principal Investigator: Peter Rasmussen, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Karin Jonczak, RN, MSN    215-481-5373    KJonczak@abingtonhealth.org   
Contact: Patricia Bussinger, RN, BSN, MBA    215-481-4761    pbussinger@amh.org   
Principal Investigator: Qaisar Shah, MD         
United States, Tennessee
Tennessee Interventional Associates Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Amy Walker Knox, RN    423-778-6216    amy@tia-pc.com   
Contact: Ben Hazlewood       ben@tia-pc.com   
Principal Investigator: Blaise Baxter, MD         
United States, Texas
CHI St. Luke's Health, Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Sree Vidya    832-355-7019    csreevidya@stlukeshealth.org   
Contact: Aline Barzilla    832-355-3710    abarzilla@stlukeshealth.org   
Principal Investigator: Hashem Shaltoni, MD         
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jacquelane Balagtas    757-507-0642    jlbalagt@sentara.com   
Contact: Samantha Bright    757-388-6124    sjrussel@sentara.com   
Principal Investigator: John Agola, MD         
United States, Washington
Multicare Medical Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Meredith Barnhart, RN    253-403-7258    Meredith.Barnhart@multicare.org   
Contact: Dalia Sherif    253-403-2698    Dalia.Sherif@multicare.org   
Principal Investigator: Brian Kott, MD         
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Michael J Alexander, M.D. Cedars-Sinai Medical Center
Principal Investigator: Wengui Yu, M.D. Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02034058     History of Changes
Other Study ID Numbers: WEAVE Trial
Study First Received: January 9, 2014
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stryker Neurovascular:
Wingspan Stent System
Wingspan Stent
Intracranial Stent
Ischemic Stroke
Intracranial Atherosclerotic Disease
Intracranial Stenosis

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Intracranial Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2014