Recruiting

Clot Removal

Sponsor:

University of Cincinnati

Code:

NCT07099599

Conditions

Ischemic Stroke, Acute

Large Vessel Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CT Perfusion

Study Details

Brief summary:

Stroke affects one patient every 40 seconds in the United States. It is most commonly caused by blood clots that develop in the blood vessels of the brain. These blood clots interrupt the normal flow of blood and oxygen to the nerve cells in the brain. When this occurs, the nerve cells can die, causing permanent damage to that area of the brain. That damage can result in loss of normal function to a patient's vision, strength, sensation, balance, or speech. These changes can remain permanent if blood flow is not restored to the brain. Thankfully, there are treatments available to help get rid of these blood clots. One of these treatments is a procedure to physically remove the blood clot causing stroke. This practice is now routinely done at all major stroke centers.

Special imaging for stroke is now available at these major stroke centers. This imaging looks at blood flow in and around the area of brain that is dying. By performing these scans after the procedure, we can see that not all of brain is being saved by the procedure. That is a problem, because we know that saving brain cells can make a big difference in how patients recover from stroke. The purpose of this study is to determine which brain tissue will not get saved by blood clot removal. We will do this by using specialized imaging after the procedure. The study will discover if there is more brain tissue that can be saved after the procedure. Once we can determine this, our next steps will be looking at ways to save this tissue in the studies that follow. For example, we will look to see if medications can be given after the procedure to help save those brain areas. This study lays the groundwork for future studies to help save all the brain tissue we possibly can from dying during the stroke. This is our best chance of getting all patients affected by stroke the opportunity to live their best lives after stroke.

Conditions

Ischemic Stroke, Acute

Large Vessel Occlusion

Study ID

NCT07099599

Start date

Sep 30, 2024

Status verified date

Jul, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults greater than or equal to 18 years of age
  • Last known normal (LKN) within 24 hours
  • Ischemic stroke due to anterior circulation LVO (intracranial internal carotid artery \[ICA\], proximal middle cerebral artery \[M1\], M1/M2 bifurcation, or proximal dominant M2 occlusion)
  • mTICI2c or mTICI3 on digital subtracted angiography (DSA) following mechanical thrombectomy

Exclusion Criteria:

  • Significant renal insufficiency (glomerular filtration rate \<30mg/ml/min2 while not on dialysis)
  • Contraindication to iodinated contrast
  • Contraindication to magnetic resonance imaging (e.g., pacemaker incompatibility)
  • Prior significant stroke in same vascular territory ipsilateral stroke
  • Tandem vessel occlusion (i.e., extracranial ICA and ipsilateral intracranial M1/M2 occlusion)
  • Greater than 4 clot retrieval attempts
  • Enrollment in another acute stroke interventional study (with the exception of thrombectomy device registries)
  • Pregnancy
  • Prisoners

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Thrombectomy-Treated Subjects with Anterior Circulation Vessel Occlusion

Patients with anterior circulation LVO or equivalent stroke treated with mechanical thrombectomy.

Interventions

CT Perfusion

CT perfusion within 90 minutes of complete angiographic reperfusion

Primary outcome measure

  • Feasibility of 90-minute CTP and 48-96-hr MRI [ Time Frame: From enrollment to 96 hours ]

Central Contacts and Locations

Central contacts

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Christina Mihova, MS, PMP

513-558-2968mihovaca@ucmail.uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Keywords

  • No Reflow
  • Microcirculatory Reperfusion
  • Ischemic Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2025-08-01.