Acute Ischemic StrokePhase 3PICASSONCT05611242
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
A Phase 3 study testing MT+CAS with IV-AP, MT+CAS with PO-AP and MT+CAT with PO-AP in people with Acute Ischemic Stroke, run by Mercy Health Ohio at 60 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- MT+CAS with IV-AP, MT+CAS with PO-AP and MT+CAT with PO-AP
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 60 sitesUnited States
- Study dates
- 8 May 2024to 8 Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
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- 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
Who cannot join
- 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
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- 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
- Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)
Trial locations and contacts
60 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexia Henricks contact
60 sites in 1 country
United States60 sites, 55 recruiting
- Recruiting
Cleveland Clinic Akron
Akron, Ohio, 44307
Debra Hudock, hudockd@ccf.org
Khaled Asi, MD
- Recruiting
Albany Medical College
Albany, New York, 12208
Wendy Stewart, stewarw@amc.edu
Alexandra Paul, MD
- Recruiting
Univerisity of New Mexico
Albuquerque, New Mexico, 87106
Jaquelyn Morales, jsmorales@salud.unm.edu
Mohammed Ismail, MD
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30309
Shardae Shavers, 404-350-2404, shardae.shavers@piedmont.org
Michael Stiefel, MD
- Recruiting
Northwell Health- South Shore University Hospital
Bay Shore, New York, 11706
James Sullivan, jsullivan30@northwell.edu
Richard Jung, MD
- Recruiting
Boca Raton - Baptist Health
Boca Raton, Florida, 33486
Margaret Scott, RN, 561-955-5784, mscott@baptisthealth.net
Brian Snelling, MD
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Robert Contreras, robert.araujocontreras@bmc.org
Thanh Nguyen, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Todd LeMatty, lematty@musc.edu
Sami Al Kasab, MD
- Completed
Ascension/Alexian Brothers Health System
Chicago, Illinois, 60606
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Chantelle Sanchez, chantelle.sanchez@northwestern.edu
Ramez Abdalla, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Taraf Jaro, taraf.jaro@bsd.uchicago.edu
Tareq Kass-Hout, MD
- Recruiting
University Hospitals
Cleveland, Ohio, 44106
Mary Andrews, mary.andrews@uhhospitals.org
Abshinek Ray, MD
- Completed
OhioHealth Research Institute
Columbus, Ohio, 43214
- Recruiting
Delray Medical Center
Delray Beach, Florida, 33484
Jordan Sprechman, jordan.sprechman@tenethealth.com
Nils Muller-Kronast, MD
- Completed
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
- Recruiting
JFK University Medical Center
Edison, New Jersey, 08837
Alexandra Burbelo, 732-321-7010, alexandra.burbelo@hmhn.org
Haralabos Zacharatos, DO
- Recruiting
McLaren Flint
Flint, Michigan, 48532
Kiona Graham, kiona.graham@mclaren.org
Aniel Majjhoo, MD
- Recruiting
Adventist health
Glendale, California, 91206
Javier Valeriano, valerij1@ah.org
Mikayel Grigoryan
- Recruiting
HCA Houston Kingwood
Houston, Texas, 77004
Kelechi Ibezim, kelechi.ibezim@hcahealthcare.com
Mohamad Ezzeldin, MD
- Recruiting
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Terri Strickland, 317-948-5450, tstrickland@iuhealth.org
Kaustubh Limaye, MD
- Recruiting
University of California, Irvine
Irvine, California, 92697
Josue Prado, josuep2@hs.uci.edu
Shuichi Suzuki, MD
- Recruiting
Baptist Health Research Institute
Jacksonville, Florida, 32207
Montserrat Petrick, montserrat.larapetrick@bmcjax.com
Amin Aghaebrahim, M.D
- Recruiting
University of Florida Health Jacksonville
Jacksonville, Florida, 32209
Yasmeen Shabbir, (904) 244-9856, yasmeen.shabbir@ufhealth.org
Yazan Radaideh, MD
- Recruiting
Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49007
Lynn Perez, lynn.perez@wmed.edu
Larry Morgan, DO
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Margaret Houghton, 913-588-5000, mhoughton3@kumc.edu
Michael Abraham, MD
- Recruiting
Michigan State University
Lansing, Michigan, 48912
Sandra Mitchell, sandra.mitchell@umhsparrow.org
Anmar Razak, MD
- Recruiting
Baptist Healthcare Systems, Inc
Lexington, Kentucky, 40299
Melissa Barnes, melissa.barnes@bhsi.com
Curtis Given, MD
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Ann Jerde, ann.jerde@louisville.edu
Saad Hasan, MD
- Recruiting
Covenant Medical Center
Lubbock, Texas, 79410
Katie Hodges, katie.hodges@covhs.org
Saif Bushnaq, MD
- Recruiting
WellStar Health System, Inc
Marietta, Georgia, 30062
Brandon Pickens, brandon.pickens@wellstar.org
Juan Carlos Martinez-Gutierrez, MD
- Recruiting
Semmes-Murphey Foundation
Memphis, Tennessee, 38120
Lorrie Garcia, lgarcia@semmes-murphey.com
Lucas Elijovich, MD
- Recruiting
University of Miami School of Medicine
Miami, Florida, 33136
Milagros Castillo, 786-450-8145, mcc2407@miami.edu
DileepA Yavagal, MD
- Recruiting
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
Madelyn Coats, madelyn.coats@infirmaryhealth.org
Christopher Southwood, MD
- Recruiting
West Virginia Univeristy
Morgantown, West Virginia, 26506
Jennifer Domico, RN, jennifer.domico@wvumedicine.org
Ansaar T. Rai, MD, MBA
- Recruiting
McLaren Macomb
Mount Clemens, Michigan, 48043
Valentyna Onishchuk, valentyna.onishchuk@mclaren.org
Aniel Majjhoo, MD
- Completed
Munster Community Hospital
Munster, Indiana, 46321
- Recruiting
Ochsner Medical Center
New Orleans, Louisiana, 70121
William Armstrong, M.S, 337-571-0160, william.armstrong@ochsner.org
Shail Thanki, MD
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Emily Svendsen, 212-241-3457, emily.svendsen@mountsinai.org
Hazem Shoirah, MD
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Michael Omini, 405-271-4912, michael-omini@ouhsc.edu
Hakeem Shakir, MD
- Recruiting
Orlando Health, Inc.
Orlando, Florida, 32806
Charlene Carlo, charlene.carlo@orlandohealth.com
Marshall Cress, MD
- Recruiting
Rutgers, The State University
Piscataway, New Jersey, 08854
Roxanne Nagurka, nagurkrm@njms.rutgers.edu
Priyank Khandelwal, MD
- Recruiting
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15212
Miranda Miller, 412-359-8850, miranda.miller@ahn.org
Evan Luther, MD
- Recruiting
Pomona Valley
Pomona, California, 91767
Raquel Rulloda, raquel.rulloda@pvhmc.org
Nazli Janjua, MD
- Recruiting
Brown University
Providence, Rhode Island, 02912
Wendy Smith, wsmith@brownhealth.org
Dylan Wolman, MD
- Recruiting
Valley Medical Center
Renton, Washington, 98055
Dione Froman, dione_froman@valleymed.org
Ali Sultan-Qurraie, MD
- Recruiting
Sutter Institute for Medical Research
Sacramento, California, 95816
Tammy Donnel, tammy.donnel@sutterhealth.org
Matthew Alexander, MD
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Andrew Grandemange, MBA, andrew.grandemange@hsc.utah.edu
Ramesh Grandhi, MD, MS
- Recruiting
California Pacific Medical Center/Mils Peninsula Medical Center
San Francisco, California, 94107
Jalyn Vickroy, jalyn.vickroy@sutterhealth.org
Fabio Settecase, MD
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Alexandria Serafine, 941-917-2225, researchinstitute@smh.com
Eyad Almallouhi, MD
- Not yet recruiting
University of Washington
Seattle, Washington, 98195
Tyler Ip, 206-744 -9389, siutai@uw.edu
Michael Levitt, MD
- Completed
Louisiana State University Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
- Recruiting
SSM Health DePaul Hospital
St Louis, Missouri, 63044
Danielle Miller, RN, danielle.miller3@ssmhealth.com
Amer Alshekhlee, MD
- Recruiting
University of South Florida
Tampa, Florida, 33606
Sai Priyanka Annadasu, sannadasu@tgh.org
Waldo R Guerrero, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Lyanna Gomez, lygomez@montefiore.org
Richard Zampolin, MD
- Recruiting
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608
Anthony Sopko, Anthony_Sopko@mercy.com
Osama O Zaidat, MD, MS
- Recruiting
St. Mary's Medical Center
West Palm Beach, Florida, 33407
Ranjit Singh, 909-214-5312, ranjit.singh@tenethealth.com
Daniel Vela-Duarte, MD
- Recruiting
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
Rosemarie Baligod, 630-933-2113, rosemarie.baligod@nm.org
Dhruvil Pandya, MD
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Wendy Jenkins, RN, wejenkin@wakehealth.edu
Stacey Wolfe, MD
- Recruiting
University of Massachusetts
Worcester, Massachusetts, 01655
Noelle Bodkin, noelle.bodkin@umassmed.edu
Anna L Kuhn, MD
- Recruiting
WellSpan Health
York, Pennsylvania, 17403
Cathy Spahr, cspahr@wellspan.org
Muhammad Niazi, MD
About this study
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).
Read the detailed description
Independent Investigator-initiated, designed and conducted non-industry study. A prospective, phase III, randomized, open-label, blinded-endpoint controlled trial (PROBE Design).
Patients presenting with symptoms of AIS in the anterior circulation with proximal carotid occlusion or severe stenosis will be assigned to either:
ARM1 (Control): Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion treatment with non-stenting approach (MT+CAT)
VERSUS
ARM2 (Intervention): Acute 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)
Randomization will be 1:1
Mechanical thrombectomy and proximal angioplasty or stenting will be performed with an FDA-cleared devices in accordance with the instructions for use (IFU). The order of each procedure (revascularization of the proximal extra-cranial carotid lesion first or after the intracranial lesion) will be left at discretion of the treating proceduralist.
Each treated patient will be followed and assessed for the primary outcome at 3 months and one year after randomization by an independent adjudicator not involved in the procedure. Optional utilization of remote assessment of NIHSS, mRS scale may be provided to selected site
- Conditions
- Acute Ischemic Stroke
- Being tested
- MT+CAS with IV-AP, MT+CAS with PO-AP, MT+CAT with PO-AP
- Keywords
- Stroke, Ischemic Stroke, Thrombectomy
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT+CAS with IV-APProcedure or surgery
Also called Thrombectomy
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.
MT+CAS with PO-APProcedure or surgery
Also called Thrombectomy
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.
MT+CAT with PO-APProcedure or surgery
Also called Thrombectomy
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
| Study group | Role | What they receive |
|---|---|---|
| MT+CAT | Experimental | Non-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) Receives: Procedure: MT+CAT with PO-AP |
| MT+CAS | Experimental | Acute 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). Receives: Procedure: MT+CAS with IV-AP; Procedure: MT+CAS with PO-AP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- No significant disability despite symptoms; able to carry out all usual duties and activities.
- Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.
- Moderate disability requiring some help, but able to walk without assistance.
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
- Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.
- Death
Measured: Time Frame: 90 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start8 May 2024
- Primary completion8 Mar 2028 (estimated)
- Study completion8 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Independent Investigator-initiated, designed and conducted non-industry study. A prospective, phase III, randomized, open-label, blinded-endpoint controlled trial (PROBE Design).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy Health Ohio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Osama O. Zaidat, Mercy Health Ohio
- Investigators
- Osama O Zaidat, MD, MS, Principal investigator, Mercy Health St. Vincent Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611242
- Sponsor's protocol ID
- 0525052522
- Acronym
- PICASSO
- Status last verified
- Dec 2025
- First submitted
- 2 Nov 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: All shared data will be aggregate.
Publications
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.
PubMed 41573330