ASSIST Registry Studying Various Operator Techniques

NCT03845491 | Completed Results FDA Device

• 1 other identifier: CDM10001414
• Study Type: observational
• Target: 1,492
• Locations: 11 countries
• Sites: 72

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).

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Percentage of Subjects With an Excellent Functional Outcome at Day 90

  90 Days (±14 days)

• Percentage of Subjects With an "Early Response" Defined by NIHSS Score

  Discharge/ Day 5-7 (Whichever is earlier)

• Quality of Life at Day 90 Based on EQ5D5L Score

  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.

  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

  During the procedure, from groin puncture to after the first pass

Other Outcomes (1)

• Safety Outcomes

  90 Days (+/- 14 Days)

Study Arms (3)

SR Classic

SR (Trevo®\]) + BGC (FlowGate2\] or Merci)

Device: 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

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

Interventions

Mechanical Thrombectomy DEVICE

Treatment of LVO with mechanical thrombectomy

Direct Aspiration; SR Classic; SR Combination

Eligibility Criteria

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

You may qualify if:

• 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
• 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
• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (72)

Banner Desert

Mesa, Arizona, 85202, United States

Location

Kaiser Permanente Fontana

Fontana, California, 92335, United States

Location

Kaiser Permanente LA

Los Angeles, California, 90027, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Doctors Medical Center Modesto

Modesto, California, 95350, United States

Location

UC Irvine

Orange, California, 92868, United States

Location

Dignity Health/ Mercy San Juan

Rancho Cordova, California, 95670, United States

Location

Stanford

Stanford, California, 94305, United States

Location

St. Mary's Medical Center

Delray Beach, Florida, 33484, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Baptist Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of S. Florida/Tampa General

Tampa, Florida, 33620, United States

Location

WellStar Health System/ Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Advocate Hospital

Oak Lawn, Illinois, 60453, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

UMASS

Worcester, Massachusetts, 01655, United States

Location

McLaren Regional Medical Facility

Flint, Michigan, 48532, United States

Location

Sparrow Health

Lansing, Michigan, 48912, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Buffalo University

Buffalo, New York, 14203, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Riverside Methodist- OHRI

Columbus, Ohio, 43214, United States

Location

Mercy St. Vincent

Toledo, Ohio, 43608, United States

Location

University of Oklahoma Medical Center (OU - OKC)

Oklahoma City, Oklahoma, 73104, United States

Location

Legacy Emanuel Medical Center

Portland, Oregon, 97232, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

Semmes Murphey Foundation

Memphis, Tennessee, 38120, United States

Location

University Medical Center- El Paso

El Paso, Texas, 79901, United States

Location

Valley Baptist Harlingen

Harlingen, Texas, 78550, United States

Location

West Virginia University Hospital

Morgantown, Virginia, 26506, United States

Location

Aurora St. Luke's

Milwaukee, Wisconsin, 53215, United States

Location

Ghent University Hospital

Ghent, Belgium

Location

AZ Sint-Jan AV Brugge Oostende

Ostend, Belgium

Location

Toronto Western Hospital

Toronto, Canada

Location

Hradec Kralove

Hradec Králové, Czechia

Location

CHU Bordeaux_GH Pellegrin

Bordeaux, France

Location

Hospital Cavale Blanche CHU Brest

Brest, 29200, France

Location

CHU Lyon- Hopital P. Wertheimer

Bron, France

Location

CHU Rouen

Rouen, France

Location

Klinikum Dortmund

Dortmund, 44137, Germany

Location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Klinikum Kassel

Kassel, Germany

Location

Klinikum Rechts Der Isar

Munich, 81675, Germany

Location

Klinikum LMU

Munich, Germany

Location

Klinikum Vest Recklinghausen

Recklinghausen, 45657, Germany

Location

Ospedale Policlinico san Martino

Genova, Italy

Location

AOPU G. Martino

Messina, Italy

Location

AO Parma

Parma, 43100, Italy

Location

AO San Camillo Forlanini

Roma, Italy

Location

Azienda Ospedaliera Siena

Siena, 53100, Italy

Location

AO Modena

Via Giardini, 1355, Italy

Location

Cheonnam University Hospital

Gwangju, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, South Korea

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Castille and León, 47003, Spain

Location

Hospital Universitario Central de Asturias - HUCA

Oviedo, Vigo, 33011, Spain

Location

Hospital Vall de Hebron

Barcelona, 08035, Spain

Location

Hospital de la Princesa

Madrid, 28010, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Son Espases de Mallorca

Palma de Mallorca, 7120, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

HUG Geneva

Geneva, Switzerland

Location

CHUV

Lausanne, Switzerland

Location

Charing Cross

London, United Kingdom

Location

Related Publications (2)

• Molaie A, Miralbes S, Naravetla B, Spiotta AM, Loehr C, Martinez-Galdamez M, McTaggart RA, Defreyne L, Vega P, Zaidat OO, Jenkins P, Mohlenbruch M, Gupta R, Liebeskind DS; ASSIST Investigators. Incomplete reperfusion and the presence of distal emboli in predicting clinical outcome after endovascular thrombectomy. BMJ Surg Interv Health Technol. 2025 Apr 10;7(1):e000345. doi: 10.1136/bmjsit-2024-000345. eCollection 2025.

  PMID: 40226203 DERIVED

• Luff MK, Khezri N, Miralbes S, Naravetla B, Spiotta AM, Loehr C, Martinez-Galdamez M, McTaggart RA, Defreyne L, Vega P, Zaidat OO, Price LL, Gupta R, Mohlenbruch MA, Liebeskind DS; ASSIST Investigators. Hemorrhagic transformation in acute ischemic stroke: hemorrhagic subtypes and symptomatic intracranial hemorrhage. J Neurointerv Surg. 2025 Jun 16;17(7):673-682. doi: 10.1136/jnis-2024-021725.

  PMID: 38969497 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sr. Clinical Project Manger
• Organization: Stryker Neurovascular

lisa.park@stryker.com

510-413-2500

Study Officials

• Rishi Gupta, MD

  WellStar Medical Group

  PRINCIPAL INVESTIGATOR

• Markus Möhlenbruch, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: January 24, 2019
• Primary Completion: April 11, 2022
• Study Completion: January 25, 2023
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Locations

CA (1); ES (8); BE (2); CZ (1); FR (4); KR (2); DE (6); IT (6); CH (3); GB (1); US (38)