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Mechanical Thrombectomy Blood Flow Reversal

NCT06721338 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-07-24

No results posted yet for this study

Summary

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

Interventions

DEVICE

Mechanical thrombectomy via blood flow reversal using BOBBY balloon guide catheter

After 2 min. of mechanical thrombectomy (MT), the side port of a BOBBY balloon guide catheter will be flushed again with heparin and the balloon deflated. A follow up angiogram will be performed to determine whether to proceed with another MT pass using the same procedure or to stop if successful recanalization has been achieved. At the end of the procedure, multiple angiograms will be performed and used to record the final TICI score. Angiograms of neck vessels will be used to rule out complications. Groin angiograms will evaluate the puncture site before closure. The catheters will then be removed, allowing hemostasis to be achieved in the groin. An angioseal closure device will be used on the arterial site if not contraindicated and a venous Vascade for the venous side.

Sponsors & Collaborators

  • MediSys Health Network

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2025-07-03
Completion
2025-07-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06721338 on ClinicalTrials.gov