ASSIST Registry Studying Various Operator Techniques

Ischemic Stroke Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845491
• Other study ID #: CDM10001414
• Status: Completed
• Start date: January 23, 2019
• Est. completion date: January 25, 2023

Study information

• Verified date: April 2023
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: January 25, 2023
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Device:
• Mechanical Thrombectomy
Treatment of LVO with mechanical thrombectomy

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Gent
Belgium	AZ Sint-Jan AV Brugge Oostende	Ostend
Canada	Toronto Western Hospital	Toronto
Czechia	Hradec Kralove	Hradec Králové
France	CHU Bordeaux_GH Pellegrin	Bordeaux
France	Hospital Cavale Blanche CHU Brest	Brest
France	CHU Lyon- Hopital P. Wertheimer	Bron
France	CHU Rouen	Rouen
Germany	Klinikum Dortmund	Dortmund
Germany	University Hospital Heidelberg	Heidelberg
Germany	Klinikum Kassel	Kassel
Germany	Klinikum LMU	Munich
Germany	Klinikum Rechts Der Isar	Munich
Germany	Klinikum Vest Recklinghausen	Recklinghausen
Italy	Ospedale Policlinico san Martino	Genova
Italy	AOPU G. Martino	Messina
Italy	AO Parma	Parma
Italy	AO San Camillo Forlanini	Roma
Italy	Azienda Ospedaliera Siena	Siena
Italy	AO Modena	Via Giardini
Korea, Republic of	Cheonnam University Hospital	Gwangju
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon
Spain	Hospital Vall de Hebron	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Universitario Central de Asturias - HUCA	Oviedo	Vigo
Spain	Hospital Son Espases de Mallorca	Palma De Mallorca
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clínico Universitario de Valladolid	Valladolid	Castilla Leon
Switzerland	University Hospital Basel	Basel
Switzerland	HUG Geneva	Geneva
Switzerland	CHUV	Lausanne
United Kingdom	Charing Cross	London
United States	Montefiore Medical Center	Bronx	New York
United States	Buffalo University	Buffalo	New York
United States	MUSC	Charleston	South Carolina
United States	Riverside Methodist- OHRI	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	St. Mary's Medical Center	Delray Beach	Florida
United States	University Medical Center- El Paso	El Paso	Texas
United States	McLaren Regional Medical Facility	Flint	Michigan
United States	Kaiser Permanente Fontana	Fontana	California
United States	Valley Baptist Harlingen	Harlingen	Texas
United States	Memorial Healthcare System	Hollywood	Florida
United States	Indiana University	Indianapolis	Indiana
United States	Baptist Jacksonville	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Sparrow Health	Lansing	Michigan
United States	Kaiser Permanente LA	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	WellStar Health System/ Kennestone Hospital	Marietta	Georgia
United States	Semmes Murphey Foundation	Memphis	Tennessee
United States	Banner Desert	Mesa	Arizona
United States	Aurora St. Luke's	Milwaukee	Wisconsin
United States	Doctors Medical Center Modesto	Modesto	California
United States	West Virginia University Hospital	Morgantown	Virginia
United States	Mount Sinai	New York	New York
United States	Advocate Hospital	Oak Lawn	Illinois
United States	University of Oklahoma Medical Center (OU - OKC)	Oklahoma City	Oklahoma
United States	UC Irvine	Orange	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	Legacy Emanuel Medical Center	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Dignity Health/ Mercy San Juan	Rancho Cordova	California
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Stanford	Stanford	California
United States	University of S. Florida/Tampa General	Tampa	Florida
United States	Mercy St. Vincent	Toledo	Ohio
United States	Westchester Medical Center	Valhalla	New York
United States	UMASS	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  France,  Germany,  Italy,  Korea, Republic of,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of disability at Day 90 assessed by modified Rankin Scale (mRS) with a good functional outcome defined by mRS score.	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.	90 Days
Secondary	Proportion of subjects with an excellent functional outcome at Day 90	Proportion of subjects with an excellent functional outcome of mRS of 0-1 at Day 90 (± 14)	90 Days
Secondary	Proportion of subjects with an "early response" defined by NIHSS score	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	Discharge/ Day 5-7 (Whichever is earlier)
Secondary	Quality of Life at day 90 based on EQ5D5L score	Quality of Life at Day 90 (± 14) assessed by EuroQoL (EQ5D5L)	Day 90