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NCT06721338 · ClinicalTrials.gov registry record · Phase 1
Mechanical Thrombectomy Blood Flow Reversal
A Phase 1 study, sponsored by MediSys Health Network.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT06721338: Clinical Trial Phase 1 study, sponsored by MediSys Health Network.
NCT06721338 is a Phase 1 study that was terminated before completion, run by MediSys Health Network. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06721338, a Phase 1 study, was terminated before completion, sponsored by MediSys Health Network.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- DEVICE Mechanical thrombectomy via blood flow reversal using BOBBY balloon guide catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2025-01-22 |
| Est. Completion | 2025-07-03 |
| Phase | Phase 1 |
Why NCT06721338 stopped before completion
NCT06721338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Mechanical thrombectomy via blood flow reversal using BOBBY balloon guide catheter is the first listed.
NCT06721338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06721338 about?
NCT06721338 is a clinical study titled "Mechanical Thrombectomy Blood Flow Reversal". 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 ...
What is the current status of trial NCT06721338?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2025-01-22. Estimated completion is 2025-07-03.
What interventions are being tested in trial NCT06721338?
The interventions under investigation include: Mechanical thrombectomy via blood flow reversal using BOBBY balloon guide catheter (DEVICE).
Who is sponsoring clinical trial NCT06721338?
This trial is sponsored by MediSys Health Network, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06721338's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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