Clinical trial NCT03845491: ASSIST Registry Studying Various Operator Techniques
Official title: ASSIST Registry to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 1492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Detailed description: ASSIST is a prospective, global, consecutive enrollment Registry of anterior circulation acute ischemic stroke patients with an LVO who undergo treatment with one of the interventional techniques using Stryker Neurovascular devices for the first pass. 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) in the anterior circulation. Data will be collected on the use of Stryker market-released neurovascular mechanical access and mechanical thrombectomy devices that are commercially available or that may be approved for commercial use during the conduct of the Registry. This Registry will also collect data, including time-to-treatment and quality of life measures, to allow for subset analyses.

Eligibility criteria: Inclusion Criteria:

1. Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus
2. Occlusion of intracranial anterior circulation vessel
3. Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 48 hours post-procedure
4. Subject is willing to comply with the protocol follow-up requirements
5. The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions For Use (IFU): Technique Category/Devices: SR Classic/SR + BGC, SR Combination/SR + Asp Cath ± Pump + BGC or LS, Direct Aspiration/Asp Cath ± Pump + BGC or LS,

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.

Primary outcomes:
measure: Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90
timeFrame: 90 Days (±14 days)
measure: Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab)
timeFrame: At the time of procedure, after the first pass
Secondary outcomes:
measure: Percentage of Subjects With an Excellent Functional Outcome at Day 90
timeFrame: 90 Days (±14 days)
measure: Percentage of Subjects With an "Early Response" Defined by NIHSS Score
timeFrame: Discharge/ Day 5-7 (Whichever is earlier)
measure: Quality of Life at Day 90 Based on EQ5D5L Score
timeFrame: Day 90 (±14 days)
measure: Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
timeFrame: At the time of procedure, after the first pass, and at the end of the procedure
measure: Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass
timeFrame: During the procedure, from groin puncture to after the first pass
measure: Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3
timeFrame: Time of procedure, from groing puncture to revascularization
Other outcomes:
measure: Safety Outcomes
timeFrame: 90 Days (+/- 14 Days)
Locations:
city: Mesa
country: United States
facility: Banner Desert
state: Arizona
city: Fontana
country: United States
facility: Kaiser Permanente Fontana
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente LA
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Modesto
country: United States
facility: Doctors Medical Center Modesto
state: California
city: Orange
country: United States
facility: UC Irvine
state: California
city: Rancho Cordova
country: United States
facility: Dignity Health/ Mercy San Juan
state: California
city: Stanford
country: United States
facility: Stanford
state: California
city: Delray Beach
country: United States
facility: St. Mary's Medical Center
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: Baptist Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of S. Florida/Tampa General
state: Florida
city: Marietta
country: United States
facility: WellStar Health System/ Kennestone Hospital
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Worcester
country: United States
facility: UMASS
state: Massachusetts
city: Flint
country: United States
facility: McLaren Regional Medical Facility
state: Michigan
city: Lansing
country: United States
facility: Sparrow Health
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo University
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Columbus
country: United States
facility: Riverside Methodist- OHRI
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Medical Center (OU - OKC)
state: Oklahoma
city: Portland
country: United States
facility: Legacy Emanuel Medical Center
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Memphis
country: United States
facility: Semmes Murphey Foundation
state: Tennessee
city: El Paso
country: United States
facility: University Medical Center- El Paso
state: Texas
city: Harlingen
country: United States
facility: Valley Baptist Harlingen
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's
state: Wisconsin
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Ostend
country: Belgium
facility: AZ Sint-Jan AV Brugge Oostende
city: Toronto
country: Canada
facility: Toronto Western Hospital
city: Hradec Králové
country: Czechia
facility: Hradec Kralove
city: Bordeaux
country: France
facility: CHU Bordeaux_GH Pellegrin
city: Brest
country: France
facility: Hospital Cavale Blanche CHU Brest
city: Bron
country: France
facility: CHU Lyon- Hopital P. Wertheimer
city: Rouen
country: France
facility: CHU Rouen
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Munich
country: Germany
facility: Klinikum Rechts Der Isar
city: Munich
country: Germany
facility: Klinikum LMU
city: Recklinghausen
country: Germany
facility: Klinikum Vest Recklinghausen
city: Genova
country: Italy
facility: Ospedale Policlinico san Martino
city: Messina
country: Italy
facility: AOPU G. Martino
city: Parma
country: Italy
facility: AO Parma
city: Roma
country: Italy
facility: AO San Camillo Forlanini
city: Siena
country: Italy
facility: Azienda Ospedaliera Siena
city: Via Giardini
country: Italy
facility: AO Modena
city: Gwangju
country: Korea, Republic of
facility: Cheonnam University Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
state: Castilla Leon
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias - HUCA
state: Vigo
city: Barcelona
country: Spain
facility: Hospital Vall de Hebron
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases de Mallorca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Geneva
country: Switzerland
facility: HUG Geneva
city: Lausanne
country: Switzerland
facility: CHUV
city: London
country: United Kingdom
facility: Charing Cross
Study officials:
affiliation: WellStar Medical Group
name: Rishi Gupta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Markus Möhlenbruch, MD
role: PRINCIPAL_INVESTIGATOR
References: