ASSIST Registry Studying Various Operator Techniques

ASSIST Registry to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).

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).

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Mechanical Thrombectomy

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.

• Study Type: Observational
• Enrollment (Actual): 1492

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • Ghent University Hospital
  • Ostend, Belgium
    • AZ Sint-Jan AV Brugge Oostende
• Canada
  • Toronto, Canada
    • Toronto Western Hospital
• Czechia
  • Hradec Králové, Czechia
    • Hradec Kralove
• France
  • Bordeaux, France
    • CHU Bordeaux_GH Pellegrin
  • Brest, France, 29200
    • Hospital Cavale Blanche CHU Brest
  • Bron, France
    • CHU Lyon- Hopital P. Wertheimer
  • Rouen, France
    • CHU Rouen
• Germany
  • Dortmund, Germany, 44137
    • Klinikum Dortmund
  • Heidelberg, Germany, 69120
    • University Hospital Heidelberg
  • Kassel, Germany
    • Klinikum Kassel
  • Munich, Germany, 81675
    • Klinikum Rechts der Isar
  • Munich, Germany
    • Klinikum LMU
  • Recklinghausen, Germany, 45657
    • Klinikum Vest Recklinghausen
• Italy
  • Genova, Italy
    • Ospedale Policlinico San Martino
  • Messina, Italy
    • AOPU G. Martino
  • Parma, Italy, 43100
    • AO Parma
  • Roma, Italy
    • AO San Camillo Forlanini
  • Siena, Italy, 53100
    • Azienda Ospedaliera Siena
  • Via Giardini, Italy, 1355
    • AO Modena
• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Cheonnam University Hospital
  • Suwon, Korea, Republic of
    • The Catholic University of Korea, St. Vincent'S Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall de Hebron
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital 12 de Octubre
  • Madrid, Spain, 28010
    • Hospital De La Princesa
  • Palma De Mallorca, Spain, 7120
    • Hospital Son Espases de Mallorca
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Castilla Leon
    • Valladolid, Castilla Leon, Spain, 47003
      • Hospital Clínico Universitario de Valladolid
  • Vigo
    • Oviedo, Vigo, Spain, 33011
      • Hospital Universitario Central de Asturias - HUCA
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
  • Geneva, Switzerland
    • HUG Geneva
  • Lausanne, Switzerland
    • CHUV
• United Kingdom
  • London, United Kingdom
    • Charing Cross
• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Banner Desert
  • California
    • Fontana, California, United States, 92335
      • Kaiser Permanente Fontana
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente LA
    • Modesto, California, United States, 95350
      • Doctors Medical Center Modesto
    • Orange, California, United States, 92868
      • UC Irvine
    • Rancho Cordova, California, United States, 95670
      • Dignity Health/ Mercy San Juan
    • Stanford, California, United States, 94305
      • Stanford
  • Florida
    • Delray Beach, Florida, United States, 33484
      • St. Mary's Medical Center
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
    • Jacksonville, Florida, United States, 32207
      • Baptist Jacksonville
    • Tampa, Florida, United States, 33620
      • University of S. Florida/Tampa General
  • Georgia
    • Marietta, Georgia, United States, 30060
      • WellStar Health System/ Kennestone Hospital
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMASS
  • Michigan
    • Flint, Michigan, United States, 48532
      • McLaren Regional Medical Facility
    • Lansing, Michigan, United States, 48912
      • Sparrow Health
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Buffalo, New York, United States, 14203
      • Buffalo University
    • New York, New York, United States, 10029
      • Mount Sinai
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist- OHRI
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Medical Center (OU - OKC)
  • Oregon
    • Portland, Oregon, United States, 97232
      • Legacy Emanuel Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny-Singer Research Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Semmes Murphey Foundation
  • Texas
    • El Paso, Texas, United States, 79901
      • University Medical Center- El Paso
    • Harlingen, Texas, United States, 78550
      • Valley Baptist Harlingen
  • Virginia
    • Morgantown, Virginia, United States, 26506
      • West Virginia University Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SR Classic; SR (Trevo®]) + 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90	This measure assesses clinical outcome using the Modified Rankin Scale (mRS). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all; no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability, and higher score indicates increased disability.	90 Days (±14 days)
Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab)	This outcome measures percentage of subjects who achieved complete reperfusion after the first pass, defined by eTICI score of 2c or greater. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: 0: Equivalent to no reperfusion or 0% filling of the downstream territory; 1: Reflects thrombus reduction without any reperfusion of distal arteries; 2a: Reperfusion in less than half or 1-49% of the territory; 2b50: 50-66% reperfusion; 2b67: 67-89% reperfusion; 2c: 90-99% reperfusion; 3: Complete or 100% reperfusion	At the time of procedure, after the first pass

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With an Excellent Functional Outcome at Day 90	Percentage of subjects with an excellent functional outcome of mRS of 0-1 at Day 90 (± 14). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all, no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability.	90 Days (±14 days)
Percentage of Subjects With an "Early Response" Defined by NIHSS Score	Percentage 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. NIHSS (National Institutes of Health Stroke Scale) is an assessment to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.	Discharge/ Day 5-7 (Whichever is earlier)
Quality of Life at Day 90 Based on EQ5D5L Score	The Euro Quality of Life Questionnaire - 5 Level 5D Version (EQ5D5L) is composed of 5 dimensions- mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is evaluated by the subject on 5 level scale: no problems, slight problems, moderate problems, severe problems and extreme problems. The outcome reported shows severe and extreme levels were combined and only 4 levels are reported.	Day 90 (±14 days)
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.	This outcome reports percentage of subjects who achieved eTICI 2b50, eTICI 2b67, eTICI 2c,or eTICI 3 on first pass after primary technique used and at the end of the endovascular procedure. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: 0: Equivalent to no reperfusion or 0% filling of the downstream territory; 1: Reflects thrombus reduction without any reperfusion of distal arteries; 2a: Reperfusion in less than half or 1-49% of the territory; 2b50: 50-66% reperfusion; 2b67: 67-89% reperfusion; 2c: 90-99% reperfusion; 3: Complete or 100% reperfusion	At the time of procedure, after the first pass, and at the end of the procedure
Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass	This outcome measures overall time (in minutes) observed from groin puncture to the specific eTICI reperfusion score at end of first pass for treatment of target occlusion. Each subject can only be in one eTICI category and therefore they are mutually exclusive. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: 0: Equivalent to no reperfusion or 0% filling of the downstream territory; 1: Reflects thrombus reduction without any reperfusion of distal arteries; 2a: Reperfusion in less than half or 1-49% of the territory; 2b50: 50-66% reperfusion; 2b67: 67-89% reperfusion; 2c: 90-99% reperfusion; 3: Complete or 100% reperfusion	During the procedure, from groin puncture to after the first pass
Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3	This outcome measures the overall time (in minutes) observed from groin puncture to final reperfusion of eTICI 2c or 3 for treatment of target occlusion. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: 0: Equivalent to no reperfusion or 0% filling of the downstream territory; 1: Reflects thrombus reduction without any reperfusion of distal arteries; 2a: Reperfusion in less than half or 1-49% of the territory; 2b50: 50-66% reperfusion; 2b67: 67-89% reperfusion; 2c: 90-99% reperfusion; 3: Complete or 100% reperfusion	Time of procedure, from groing puncture to revascularization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcomes	Prespecified safety outcome measures include all-cause mortality and stroke-related mortality up to 90 days (±14), device and/or procedure related SAEs up to 90 Days (±14), neurological deterioration at 24 hours post procedure, embolization to new territory adjudicated by core lab. and neurological deterioration at 24 hours post-procedure to 48 hours	90 Days (+/- 14 Days)

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Rishi Gupta, MD, WellStar Medical Group; Principal Investigator: Markus Möhlenbruch, MD, University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CDM10001414

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No