Mechanical Thrombectomy Blood Flow Reversal

NCT06721338 | Terminated Phase 1 FDA Device

• 1 other identifier: 2245475
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

stroke; large vessel occlusion; blood flow reversal; mechanical thrombectomy

Outcome Measures

Primary Outcomes (1)

• Feasibility of Treatment Defined by the Abscence of Distal Emboli and a mTICI score of ≥2b per Participant Post-Procedure

  Whether this experimental procedure (blood flow reversal) on performing acute intervention (mechanical thrombectomy) for stroke is feasible, measured by the absence of distal emboli post procedure (measured as a continuous variable with none being 0) and a reperfusion with a modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2b. A TICI Score is a tool used to grade how well the blood flow was restored in the brain's circulation after the blood clot was removed. The score ranges from 0 to 3, but the acceptable score is ≥2b.

  From enrollment to the end of treatment at 3 months

Study Arms (1)

Stroke patients with LVO

EXPERIMENTAL

Eligible patients for the study will be stroke patients with large vessel occlusion who meet inclusion 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 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 your 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.

Device: Mechanical thrombectomy via blood flow reversal using BOBBY balloon guide catheter

Interventions

Mechanical thrombectomy via blood flow reversal using BOBBY balloon guide catheter DEVICE

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.

Stroke patients with LVO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Large vessel occlusion on the posterior circulation, with tandem occlusion, has known history of patent foramen ovale, has deep venous thrombosis of lower extremity, absent family members to consent, large established stroke on CT/CT Perfusion with ASPECTS \<5, the individual consenting is a non-English speaker, and poor baseline function will be excluded from the study

Sponsors & Collaborators

• MediSys Health Network: lead

Study Sites (1)

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: January 22, 2025
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)