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Trial record 9 of 36 for:    mechanical thrombectomy | Recruiting Studies | stroke

ASSIST Registry Studying Various Operator Techniques

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ClinicalTrials.gov Identifier: NCT03845491
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Brief Summary:
The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO).

Condition or disease Intervention/treatment
Ischemic Stroke Device: Mechanical Thrombectomy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: ASSIST Registry's Purpose is to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
SR Classic
SR (Trevo®]) + BGC (FlowGate2] or Merci)
Device: Mechanical Thrombectomy
Treatment of LVO with mechanical thrombectomy

SR Combination

SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump

+ LS (AXS Infinity LS, AXS Infinity LS Plus)

or

SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci)

Device: Mechanical Thrombectomy
Treatment of LVO with mechanical thrombectomy

Direct Aspiration

Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus)

or

Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci)

Device: Mechanical Thrombectomy
Treatment of LVO with mechanical thrombectomy




Primary Outcome Measures :
  1. Severity of disability at Day 90 assessed by modified Rankin Scale (mRS) with a good functional outcome defined by mRS score. [ Time Frame: 90 Days ]
    Severity of disability at Day 90 (± 14) assessed by modified Rankin Scale (mRS) with a good functional outcome defined as mRS of 0-2 for each technique.


Secondary Outcome Measures :
  1. Proportion of subjects with an excellent functional outcome at Day 90 [ Time Frame: 90 Days ]
    Proportion of subjects with an excellent functional outcome of mRS of 0-1 at Day 90 (± 14)

  2. Proportion of subjects with an "early response" defined by NIHSS score [ Time Frame: Discharge/ Day 5-7 (Whichever is earlier) ]
    Proportion of subjects with an "early response" at Discharge/Day5-7 (whichever is earlier) defined as a NIHSS drop of ≥10 points from baseline or NIHSS score of 0 or 1

  3. Quality of Life at day 90 based on EQ5D5L score [ Time Frame: Day 90 ]
    Quality of Life at Day 90 (± 14) assessed by EuroQoL (EQ5D5L)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects experiencing acute ischemic stroke (AIS) who are eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus
Criteria

Inclusion Criteria:

  • Subjects experiencing acute ischemic stroke (AIS) who are eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus
  • Occlusion of intracranial anterior circulation vessel
  • Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 48 hours post-procedure
  • Subject is willing to comply with the protocol follow-up requirements
  • Subject is treated using at least one of the defined techniques for the first pass in the neurovasculature to remove thrombus.

Exclusion Criteria:

  • The subject is participating in another device trial or any other clinical trial where the study procedure or treatment might confound this study's endpoint.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845491


Contacts
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Contact: Alice Lin 5104132457 alice.lin@stryker.com

Locations
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United States, California
National Skull Base Center Recruiting
Thousand Oaks, California, United States, 91360
Contact: Anastasia Vechera       Anastasia.vechera@nsbf.us   
Principal Investigator: Muhammad Taqi         
United States, Florida
Memorial Healthcare System Recruiting
Hollywood, Florida, United States, 33021
Contact: Nithya Sundararaman       NSundararaman@mhs.net   
Principal Investigator: Andrey Lima         
United States, Georgia
WellStar Health System/ Kennestone Hospital Recruiting
Marietta, Georgia, United States, 30060
Contact: Marianne Bain, RN    470-793-4040    marianne.bain@wellstar.org   
Principal Investigator: Rishi Gupta         
United States, Michigan
McLaren Regional Medical Facility Recruiting
Flint, Michigan, United States, 48532
Contact: Melissa Szemites       melissa.szemites@mclaren.org   
Sub-Investigator: Aniel Majjhoo         
Sub-Investigator: Mahmoud Rayas         
Principal Investigator: Bharath Naravetla         
United States, Oregon
Legacy Emanuel Medical Center Recruiting
Portland, Oregon, United States, 97232
Contact: Karla Hummer       kkummer@LHS.org   
Contact: Paul Fitzpatrick       pfitzpatri@lhs.org   
United States, Virginia
West Virginia University Hospital Recruiting
Morgantown, Virginia, United States, 26506
Contact: Jennifer Domico       jennifer.domico@wvumedicine.org   
Principal Investigator: Ansaar Rai         
Germany
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Susanne Bonekamp    +49 6221 56 35710    susanne.bonekamp@gmail.com   
Principal Investigator: Markus A Mohlenbruch         
Klinikum Vest Recklinghausen Recruiting
Recklinghausen, Germany, 45657
Contact: Stephan Bossmann       stephan.bossmann@klinikum-vest.de   
Contact: Christian Loehr       christian.loehr@klinikum-vest.de   
Principal Investigator: Christian Loehr         
Italy
Ospedale Policlinico san Martino Recruiting
Genova, Italy
Contact: Laura Malfatto       laura.malfatto@hsanmartino.it   
Principal Investigator: Lucio Castellan         
Spain
Hospital Clínico Universitario de Valladolid Recruiting
Valladolid, Castilla Leon, Spain, 47003
Contact: Jorge Galván       jcfgalvan@gmail.com   
Principal Investigator: Mario Martínez-Galdamez         
Hospital Universitario Central de Asturias - HUCA Recruiting
Oviedo, Vigo, Spain, 33011
Contact: Charo G Arenas    +34985108000 ext 39706    arenascharo@hotmail.com   
Principal Investigator: Pedro V Vega         
Hospital de la Princesa Recruiting
Madrid, Spain, 28010
Contact: Eduardo Barcena    +34 654920671    edubr81@gmail.com   
Principal Investigator: Jose L Caniego         
Sub-Investigator: Juan Vega         
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Manuel Moreu    +34 699 856 388    manumoreu@gmail.com   
Principal Investigator: Luis L Ibor         
Sub-Investigator: Santiago Rosati         
Sub-Investigator: Carlos Gómez-Escalonilla         
Hospital Son Espases de Mallorca Recruiting
Palma De Mallorca, Spain, 7120
Contact: Salvador Miralbes, MD       salvador.miralbes@quironsalud.es   
Hospital Universitario Marqués de Valdecilla Recruiting
Santander, Spain, 39008
Contact: Eduardo Torres       Eduardo.torres@scs.es   
Principal Investigator: Andrés González Mandly         
Sponsors and Collaborators
Stryker Neurovascular
Investigators
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Principal Investigator: Rishi Gupta, MD WellStar Medical Group
Principal Investigator: Markus Möhlenbruch, MD University Hospital Heidelberg

Additional Information:

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Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT03845491     History of Changes
Other Study ID Numbers: T4037
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No