SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke

Status: Active, not recruiting
Location: See all (31) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: No
View:

⁃ Adults (18-85 years) with the final diagnosis of an acute ischemic stroke

⁃ NIH Stroke Scale Score (NIHSS) ≥ 6

⁃ Last known well to groin puncture or medical management between 0 to 24 hours

⁃ Pre-stroke modified Rankin Scale score (mRS) of 0-1

⁃ Eligible for thrombectomy or medical management

⁃ Signed Informed Consent obtained

⁃ Subject willing to comply with the protocol follow-up requirements

⁃ Anticipated life expectancy of at least 3 months

⁃ Specific Neuroimaging Inclusion Criteria:

⁃ Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA

⁃ Large infarct-core lesion on at least one of the following:

• 1. Non-Contrast CT (ASPECTS of 3-5),

• 2. CT perfusion (rCBF<30% ≥50cc),

• 3. MRI-DWI (ADC<620 ≥50cc)

Locations
United States
California
Kaiser Permanente
Los Angeles
Florida
Baptist Health
Jacksonville
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Rush University Medical Center
Chicago
Indiana
Ascension St. Vincent Hospital
Indianapolis
Kansas
University of Kansas Medical Center
Kansas City
Michigan
Spectrum Health Hospital
Grand Rapids
New York
Westchester Medical Center
Valhalla
Ohio
Cleveland Clinic Foundation
Cleveland
University Hospitals Cleveland Medical Center
Cleveland
Riverside Methodist Hospital - OhioHealth
Columbus
Pennsylvania
Abington Jefferson Health
Abington
The Hospital of the University of Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
Tennessee
Semmes Murphey Clinic - University of Tennessee Health Science Center
Memphis
Texas
Dell Seton Medical Center at the University of Texas at Austin
Austin
Valley Baptist Medical Center
Harlingen
The University of Texas Health Science Center at Houston
Houston
Wisconsin
Ascension Wisconsin
Milwaukee
Other Locations
Australia
The Royal Adelaide Hospital (RAH)
Adelaide
Liverpool Hospital - South Western Sydney Clinical School
Liverpool
Royal Melbourne Hospital
Melbourne
Canada
University of Alberta
Edmonton
University Health Network - Toronto Western Hospital
Toronto
New Zealand
Christchurch Hospital
Christchurch
Spain
Hospital Universitario Germans Trias i Pujol
Badalona
Hospital Clínic i Provincial de Barcelona
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Clínico Universitario de Valladolid
Valladolid
Switzerland
Universität Basel
Basel
Time Frame
Start Date: October 11, 2019
Estimated Completion Date: December 31, 2023
Participants
Target number of participants: 352
Treatments
Experimental: Endovascular Thrombectomy plus Medical Management
Active Comparator: Medical Management
Authors
Osman Kozak, Nabeel A. Herial, Jenny P. Tsai, Daniel Sahlein, Steven Warach, Spiros L. Blackburn, Lucas Elijovich, Michael Chen, William Hicks, Navdeep X. Sangha, Daniel Gibson, Amrou Sarraj, Pascal Jabbour, Yin Hu, Andrew D Barreto, Nathan Manning, Ricardo A. Hanel, Michael T. Mullen, Juan F. Arenallis, Hussain M. Shazam, Jordi Blasco, Michael G. Abraham, Joanna Schaafsma, Teddy Wu, Sophia Sundararajan, Pere Cardona Portela, Bernard Yan, Timothy J. Kleinig, Dennis Cordato, Bruce Campbell, Marc Ribo, Ameer E. Hassan, Santiago Ortega-Gutierrez, Ronald F. Budzik, Natalia Pérez de la Ossa, (Australia and Oceania) Bruce CV Campbell, (Europe) Marc Ribo
Sponsors
Collaborators: Stryker Neurovascular, The University of Texas Health Science Center, Houston
Leads: University Hospitals Cleveland Medical Center

This content was sourced from clinicaltrials.gov

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