Mechanical Thrombectomy Blood Flow Reversal

Description

The goal of this study is to reduce the chance of complications during mechanical thrombectomy, which is a procedure to remove blockages from the brain. This study is combining two established and standard procedures for the first time so that the patient may benefit from both and reduce the chance of another stroke during the procedure. Our main goal is to show that this combination is safe, feasible, and effective for stroke patients. The combined procedures are described as follows: 1. Mechanical Thrombectomy: while the patient is asleep under light or general anesthesia, a surgical cut will be made in their groin to access the common femoral artery. A catheter will be inserted into this cut so that a wire can advance through the artery. Using an imaging technique called angiography, a blueprint is used to advance the wire from an artery in their groin, to their neck, into their brain and locate the target blockage. Once the target is located, more wires and catheters are used to finetune the extraction process. A stent retriever is placed on standby before removing the blockage. 2. Reversal Flow: before the mechanical thrombectomy is completed, a surgical cut will be made to the other groin that has not been operated on. A catheter and wire are used to access the newly punctured femoral vein. A device called an aspiration filter will connect a catheter from their femoral vein to an aspiration catheter at the target site. Once this connection is complete, full removal of the blockage by the stent retriever will occur while blood flow is reversed.

Conditions

Stroke, Large Vessel Occlusion

Study Overview

Study Details

Study overview

The goal of this study is to reduce the chance of complications during mechanical thrombectomy, which is a procedure to remove blockages from the brain. This study is combining two established and standard procedures for the first time so that the patient may benefit from both and reduce the chance of another stroke during the procedure. Our main goal is to show that this combination is safe, feasible, and effective for stroke patients. The combined procedures are described as follows: 1. Mechanical Thrombectomy: while the patient is asleep under light or general anesthesia, a surgical cut will be made in their groin to access the common femoral artery. A catheter will be inserted into this cut so that a wire can advance through the artery. Using an imaging technique called angiography, a blueprint is used to advance the wire from an artery in their groin, to their neck, into their brain and locate the target blockage. Once the target is located, more wires and catheters are used to finetune the extraction process. A stent retriever is placed on standby before removing the blockage. 2. Reversal Flow: before the mechanical thrombectomy is completed, a surgical cut will be made to the other groin that has not been operated on. A catheter and wire are used to access the newly punctured femoral vein. A device called an aspiration filter will connect a catheter from their femoral vein to an aspiration catheter at the target site. Once this connection is complete, full removal of the blockage by the stent retriever will occur while blood flow is reversed.

Safety and Efficacy of Mechanical Thrombectomy Utilizing Reversal Flow

Mechanical Thrombectomy Blood Flow Reversal

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Jamaica

Jamaica Hospital Medical Center, Jamaica, New York, United States, 11418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age \> 18-year-old
  • * Last known well less than 24 hours
  • * Large vessel occlusion of intra-cranial ICA or MCA M1 segment
  • * ASPECTS of 4 or above
  • * Baseline modified Rankin scale of 3 or less.
  • * More than 20 ml penumbra on CTP
  • * Less than 100 ml infarct core on CTP

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MediSys Health Network,

Study Record Dates

2026-03