Recruiting
Phase 3

Thrombectomy Trial

Sponsor:

Mercy Health Ohio

Code:

NCT05611242

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MT+CAS with IV-AP

MT+CAS with PO-AP

MT+CAT with PO-AP

Study Details

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).

Conditions

Acute Ischemic Stroke

Study ID

NCT05611242

Start date

May 8, 2024

Status verified date

Dec, 2025

Completion date

Dec 8, 2028

Anticipated

Primary completion date

Mar 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 to 79 years of age (before the 80th birthday)
2. Presenting with symptoms consistent with AIS
3. 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%
4. NIHSS ≥ 4
5. Ability to randomize and start endovascular therapy within 16 hours of stroke onset
6. Pre-stroke mRS score 0-2
7. Ability to obtain signed informed consent
8. 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.
9. Acute Neurological Deficit with Imaging evidence of Tandem Lesion:

Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion
10. Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy

Exclusion Criteria:

1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications
3. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) despite medication
4. CT evidence of the following conditions:

  • Midline shift or herniation
  • Evidence of intracranial hemorrhage
  • Mass effect with effacement of the ventricles
5. Acute bilateral strokes
6. Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.
7. Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
8. 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
9. Baseline platelet count <100,000 per microliter (μl)
10. Life expectancy less than one year prior to stroke onset
11. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes
12. 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
13. Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)

Study Design

Enrollment

404 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MT+CAT

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)

experimental: MT+CAS

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).

Interventions

MT+CAS with IV-AP

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-AP

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-AP

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

Primary outcome measure

  • 90-day Modified Rankin Scale ordinal shift [ Time Frame: Time Frame: 90 days post randomization ]

Central Contacts and Locations

Central contacts

Jasmine M Olvany, PhD

(419)-251-4264jolvany@mercy.com

Alexia Henricks

ahenricks@mercy.com

Locations

Mobile Infirmary Medical Center

Recruiting

Mobile, Alabama, United States, 36607

Contacts

Madelyn Coats

madelyn.coats@infirmaryhealth.org

Principal Investigator:

Christopher Southwood, MD

Adventist health

Recruiting

Glendale, California, United States, 91206

Contacts

Javier Valeriano

valerij1@ah.org

Principal Investigator:

Mikayel Grigoryan

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Josue Prado

josuep2@hs.uci.edu

Principal Investigator:

Shuichi Suzuki, MD

Pomona Valley

Recruiting

Pomona, California, United States, 91767

Contacts

Raquel Rulloda

raquel.rulloda@pvhmc.org

Principal Investigator:

Nazli Janjua, MD

Sutter Institute for Medical Research

Recruiting

Sacramento, California, United States, 95816

Contacts

Tammy Donnel

tammy.donnel@sutterhealth.org

Principal Investigator:

Matthew Alexander, MD

California Pacific Medical Center/Mils Peninsula Medical Center

Recruiting

San Francisco, California, United States, 94107

Contacts

Jalyn Vickroy

jalyn.vickroy@sutterhealth.org

Principal Investigator:

Fabio Settecase, MD

Boca Raton - Baptist Health

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

Margaret Scott, RN

561-955-5784mscott@baptisthealth.net

Principal Investigator:

Brian Snelling, MD

Delray Medical Center

Recruiting

Delray Beach, Florida, United States, 33484

Contacts

Jordan Sprechman

jordan.sprechman@tenethealth.com

Principal Investigator:

Nils Muller-Kronast, MD

Baptist Health Research Institute

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Montserrat Petrick

montserrat.larapetrick@bmcjax.com

Principal Investigator:

Amin Aghaebrahim, M.D

University of Florida Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Yasmeen Shabbir

(904) 244-9856yasmeen.shabbir@ufhealth.org

Principal Investigator:

Yazan Radaideh, MD

University of Miami School of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Milagros Castillo

786-450-8145mcc2407@miami.edu

Principal Investigator:

DileepA Yavagal, MD

Orlando Health, Inc.

Recruiting

Orlando, Florida, United States, 32806

Contacts

Charlene Carlo

charlene.carlo@orlandohealth.com

Principal Investigator:

Marshall Cress, MD

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Alexandria Serafine

941-917-2225researchinstitute@smh.com

Principal Investigator:

Eyad Almallouhi, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Sai Priyanka Annadasu

sannadasu@tgh.org

Principal Investigator:

Waldo R Guerrero, MD

St. Mary's Medical Center

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Ranjit Singh

909-214-5312ranjit.singh@tenethealth.com

Principal Investigator:

Daniel Vela-Duarte, MD

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Shardae Shavers

404-350-2404shardae.shavers@piedmont.org

Principal Investigator:

Michael Stiefel, MD

WellStar Health System, Inc

Recruiting

Marietta, Georgia, United States, 30062

Contacts

Brandon Pickens

brandon.pickens@wellstar.org

Principal Investigator:

Juan Carlos Martinez-Gutierrez, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Chantelle Sanchez

chantelle.sanchez@northwestern.edu

Principal Investigator:

Ramez Abdalla, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Taraf Jaro

taraf.jaro@bsd.uchicago.edu

Principal Investigator:

Tareq Kass-Hout, MD

Northwestern Medicine Central DuPage Hospital

Recruiting

Winfield, Illinois, United States, 60190

Contacts

Rosemarie Baligod

630-933-2113rosemarie.baligod@nm.org

Principal Investigator:

Dhruvil Pandya, MD

Indiana University Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Terri Strickland

317-948-5450tstrickland@iuhealth.org

Principal Investigator:

Kaustubh Limaye, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Margaret Houghton

913-588-5000mhoughton3@kumc.edu

Principal Investigator:

Michael Abraham, MD

Baptist Healthcare Systems, Inc

Recruiting

Lexington, Kentucky, United States, 40299

Contacts

Melissa Barnes

melissa.barnes@bhsi.com

Principal Investigator:

Curtis Given, MD

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Ann Jerde

ann.jerde@louisville.edu

Principal Investigator:

Saad Hasan, MD

Ochsner Medical Center

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

William Armstrong, M.S

337-571-0160william.armstrong@ochsner.org

Principal Investigator:

Shail Thanki, MD

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Robert Contreras

robert.araujocontreras@bmc.org

Principal Investigator:

Thanh Nguyen, MD

University of Massachusetts

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Noelle Bodkin

noelle.bodkin@umassmed.edu

Principal Investigator:

Anna L Kuhn, MD

McLaren Flint

Recruiting

Flint, Michigan, United States, 48532

Contacts

Kiona Graham

kiona.graham@mclaren.org

Principal Investigator:

Aniel Majjhoo, MD

Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Lynn Perez

lynn.perez@wmed.edu

Principal Investigator:

Larry Morgan, DO

Michigan State University

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Sandra Mitchell

sandra.mitchell@umhsparrow.org

Principal Investigator:

Anmar Razak, MD

McLaren Macomb

Recruiting

Mount Clemens, Michigan, United States, 48043

Contacts

Valentyna Onishchuk

valentyna.onishchuk@mclaren.org

Principal Investigator:

Aniel Majjhoo, MD

SSM Health DePaul Hospital

Recruiting

St Louis, Missouri, United States, 63044

Contacts

Danielle Miller, RN

danielle.miller3@ssmhealth.com

Principal Investigator:

Amer Alshekhlee, MD

JFK University Medical Center

Recruiting

Edison, New Jersey, United States, 08837

Contacts

Alexandra Burbelo

732-321-7010alexandra.burbelo@hmhn.org

Principal Investigator:

Haralabos Zacharatos, DO

Rutgers, The State University

Recruiting

Piscataway, New Jersey, United States, 08854

Contacts

Roxanne Nagurka

nagurkrm@njms.rutgers.edu

Principal Investigator:

Priyank Khandelwal, MD

Univerisity of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Jaquelyn Morales

jsmorales@salud.unm.edu

Principal Investigator:

Mohammed Ismail, MD

Albany Medical College

Recruiting

Albany, New York, United States, 12208

Contacts

Wendy Stewart

stewarw@amc.edu

Principal Investigator:

Alexandra Paul, MD

Northwell Health- South Shore University Hospital

Recruiting

Bay Shore, New York, United States, 11706

Contacts

James Sullivan

jsullivan30@northwell.edu

Principal Investigator:

Richard Jung, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Emily Svendsen

212-241-3457emily.svendsen@mountsinai.org

Principal Investigator:

Hazem Shoirah, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Lyanna Gomez

lygomez@montefiore.org

Principal Investigator:

Richard Zampolin, MD

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Wendy Jenkins, RN

wejenkin@wakehealth.edu

Principal Investigator:

Stacey Wolfe, MD

Cleveland Clinic Akron

Recruiting

Akron, Ohio, United States, 44307

Contacts

Debra Hudock

hudockd@ccf.org

Principal Investigator:

Khaled Asi, MD

University Hospitals

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Mary Andrews

mary.andrews@uhhospitals.org

Principal Investigator:

Abshinek Ray, MD

Mercy Health St. Vincent Medical Center

Recruiting

Toledo, Ohio, United States, 43608

Contacts

Anthony Sopko

Anthony_Sopko@mercy.com

Principal Investigator:

Osama O Zaidat, MD, MS

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Michael Omini

405-271-4912michael-omini@ouhsc.edu

Principal Investigator:

Hakeem Shakir, MD

Allegheny Health Network Research Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Miranda Miller

412-359-8850miranda.miller@ahn.org

Principal Investigator:

Evan Luther, MD

WellSpan Health

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Cathy Spahr

cspahr@wellspan.org

Principal Investigator:

Muhammad Niazi, MD

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Wendy Smith

wsmith@brownhealth.org

Principal Investigator:

Dylan Wolman, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Todd LeMatty

lematty@musc.edu

Principal Investigator:

Sami Al Kasab, MD

Semmes-Murphey Foundation

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Lorrie Garcia

lgarcia@semmes-murphey.com

Principal Investigator:

Lucas Elijovich, MD

HCA Houston Kingwood

Recruiting

Houston, Texas, United States, 77004

Contacts

Kelechi Ibezim

kelechi.ibezim@hcahealthcare.com

Principal Investigator:

Mohamad Ezzeldin, MD

Covenant Medical Center

Recruiting

Lubbock, Texas, United States, 79410

Contacts

Katie Hodges

katie.hodges@covhs.org

Principal Investigator:

Saif Bushnaq, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Andrew Grandemange, MBA

andrew.grandemange@hsc.utah.edu

Principal Investigator:

Ramesh Grandhi, MD, MS

Valley Medical Center

Recruiting

Renton, Washington, United States, 98055

Contacts

Dione Froman

dione_froman@valleymed.org

Principal Investigator:

Ali Sultan-Qurraie, MD

West Virginia Univeristy

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Jennifer Domico, RN

jennifer.domico@wvumedicine.org

Principal Investigator:

Ansaar T. Rai, MD, MBA

More Information

Sponsor

Mercy Health Ohio

Last update posted

Oct 2, 2026

Last verified

Dec, 2025

Keywords

  • Stroke
  • Ischemic Stroke
  • Thrombectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Mercy Health Ohio on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.