Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
PICASSO
1 other identifier
interventional
404
1 country
51
Brief Summary
The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2024
Typical duration for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2022
CompletedFirst Posted
Study publicly available on registry
November 10, 2022
CompletedStudy Start
First participant enrolled
May 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2027
ExpectedDecember 17, 2025
December 1, 2025
1.8 years
November 2, 2022
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
90-day Modified Rankin Scale ordinal shift
Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death. 0 = No symptoms at all. 1. No significant disability despite symptoms; able to carry out all usual duties and activities. 2. Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3. Moderate disability requiring some help, but able to walk without assistance. 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. Severe disability; bedridden, incontinent, and requiring constant nursing care and attention. 6. Death
Time Frame: 90 days post randomization
Study Arms (2)
MT+CAT
EXPERIMENTALNon-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion angioplasty or aspiration (MT+CAT)
MT+CAS
EXPERIMENTALAcute carotid stenting (ACS) approach constitutes BMM+IAT with acute carotid stenting (ACS) of the extracranial proximal carotid artery, spanning the cervical internal carotid artery (ICA), ICA origin, and the distal common carotid artery (CCA, across the bifurcation) as in the example of left (L) carotid stenting figure below (MT+CAS). Within the stenting arm, there will be 2 different subgroups based on the antiplatelet treatment protocol per the site standard of care (oral antiplatelet or IV antiplatelet medication (e.g., Cangrelor or others).
Interventions
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added intravenous antiplatelet therapy.
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy.
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy
Eligibility Criteria
You may qualify if:
- to 79 years of age (before the 80th birthday)
- Presenting with symptoms consistent with AIS
- Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis related to atherosclerosis requiring treatment on non-invasive imaging ≥70%
- NIHSS ≥ 4
- Ability to randomize and start endovascular therapy within 16 hours of stroke onset
- Pre-stroke mRS score 0-2
- Ability to obtain signed informed consent
- ASPECTS Score ≥7 via non-contrast CT or MRI (DWI) for subjects ≤6 hours from stroke onset OR ASPECTS Score ≥7 + infarct core volume \<50 cc quantified by CTP (rCBF\<30%) OR \<25 cc quantified by MRI-DWI (AxBxC/2) for subjects with endovascular therapy starting between \>6h to 16 hours from stroke onset, given the need for antiplatelet therapy.
- Acute Neurological Deficit with Imaging evidence of Tandem Lesion:
- Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion
- Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy
You may not qualify if:
- Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
- Known severe allergy (more than a rash) to contrast media uncontrolled by medications
- Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) despite medication
- CT evidence of the following conditions:
- Midline shift or herniation
- Evidence of intracranial hemorrhage
- Mass effect with effacement of the ventricles
- Acute bilateral strokes
- Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.
- Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
- Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>1.7 or Partial Thromboplastin Time (PTT) \> 3 times of normal
- Baseline platelet count \<100,000 per microliter (μl)
- Life expectancy less than one year prior to stroke onset
- Participation in another randomized clinical trial that could confound the evaluation of the study outcomes
- Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
University of California, Irvine
Irvine, California, 92697, United States
Pomona Valley
Pomona, California, 91767, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
California Pacific Medical Center/Mils Peninsula Medical Center
San Francisco, California, 94107, United States
Boca Raton - Baptist Health
Boca Raton, Florida, 33486, United States
Delray Medical Center
Delray Beach, Florida, 33484, United States
Baptist Health Research Institute
Jacksonville, Florida, 32207, United States
University of Florida Health Jacksonville
Jacksonville, Florida, 32209, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Orlando Health, Inc.
Orlando, Florida, 32806, United States
University of South Florida
Tampa, Florida, 33606, United States
St. Mary's Medical Center
West Palm Beach, Florida, 33407, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
WellStar Health System, Inc
Marietta, Georgia, 30062, United States
Ascension/Alexian Brothers Health System
Chicago, Illinois, 60606, United States
University of Chicago
Chicago, Illinois, 60637, United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Munster Community Hospital
Munster, Indiana, 46321, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Baptist Healthcare Systems, Inc
Lexington, Kentucky, 40299, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Louisiana State University Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
McLaren Flint
Flint, Michigan, 48532, United States
Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49007, United States
Michigan State University
Lansing, Michigan, 48912, United States
McLaren Macomb
Mount Clemens, Michigan, 48043, United States
SSM Health DePaul Hospital
St Louis, Missouri, 63044, United States
JFK University Medical Center
Edison, New Jersey, 08837, United States
Rutgers, The State University
Piscataway, New Jersey, 08854, United States
Albany Medical College
Albany, New York, 12208, United States
Northwell Health- South Shore University Hospital
Bay Shore, New York, 11706, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15212, United States
WellSpan Health
York, Pennsylvania, 17403, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Semmes-Murphey Foundation
Memphis, Tennessee, 38120, United States
DHR Health Institute for Research and Development
Edinburg, Texas, 78539, United States
HCA Houston Kingwood
Houston, Texas, 77004, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Valley Medical Center
Renton, Washington, 98055, United States
University of Washington
Seattle, Washington, 98195, United States
West Virginia Univeristy
Morgantown, West Virginia, 26506, United States
Related Publications (1)
Al Kasab S, Nguyen TN, Abdalkader M, Rai A, Boo S, Kass-Hout T, Hurley M, Sultan-Qurraie A, Lin E, Given C, Elijovich L, Badruddin A, Janjua N, Jung R, Khandelwal P, Southwood C, Majjhoo A, Guerrero WR, Mueller-Kronast N, Alshekhlee A, Martinez-Gutierrez JC, Ezzeldin M, Cress M, Niazi M, Paul A, Snelling B, Razak A, Grandhi R, Morgan L, Settecase F, English J, Fernandez P, Zacharatos H, Alexander M, Asif K, Kicielinski KP, Cuellar H, Limaye K, Abraham M, Yaghi S, de Havenon A, Almekhlafi M, Linfante I, Teleb MS, Thomalla G, Gress DR, Smith WS, Brown S, Olvany J, Ibrahim L, Khan N, Zaidat OO. PICASSO (Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem Lesion or Local Occlusion) Thrombectomy Randomized Trial: Study Protocol and Rationale. Stroke Vasc Interv Neurol. 2025 Jun 17;5(5):e001690. doi: 10.1161/SVIN.124.001690. eCollection 2025 Sep.
PMID: 41573330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osama O Zaidat, MD, MS
Mercy Health St. Vincent Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neuroscience and Stroke Medical Director
Study Record Dates
First Submitted
November 2, 2022
First Posted
November 10, 2022
Study Start
May 8, 2024
Primary Completion
March 8, 2026
Study Completion (Estimated)
May 8, 2027
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
All shared data will be aggregate.