Millipede System for Ischemic Stroke

(MARRS Trial)

Recruiting at 29 trial locations

Overseen By Veronica Lewis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Perfuze

Must not be taking: Anticoagulants, Thrombin inhibitors

Disqualifiers: Pregnancy, Recent stroke, Severe hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: During procedure

246 Participants Needed

Trial Summary

What is the purpose of this trial?

The objectives of the study are to examine the performance and safety characteristics of the Millipede System when used for revascularization of patients with acute ischemic stroke due to Large Vessel Occlusions (LVOs) and to record associated clinical outcomes.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on oral anti-coagulant therapy with an INR over 3.0 or have been treated with heparin or a direct thrombin inhibitor recently, you may not be eligible to participate.

What data supports the effectiveness of the Millipede System treatment for ischemic stroke?

Research on similar treatments, like the Penumbra System and other aspiration catheters, shows that mechanical thrombectomy (removing a blood clot from a blood vessel) can be effective in treating ischemic stroke. These studies suggest that using devices to directly remove clots can improve outcomes for stroke patients. ^{1 2 3 4 5}

How is the Millipede System treatment for ischemic stroke different from other treatments?

The Millipede System, which includes the Millipede 070 Aspiration Catheter and Millipede 088 Access Catheter, is unique because it uses a mechanical approach to remove blood clots in the brain by aspiration (suction), potentially offering faster and more effective treatment compared to traditional methods. This system is similar to other aspiration devices like the Penumbra System but may offer advantages in terms of catheter design and efficiency. ^{3 5 6 7 8}

Research Team

Ricardo Hanel

Principal Investigator

Baptist Health Research Institute, Jacksonville, USA

Raul Nogueira, MD

Principal Investigator

University of Pittsburgh Medical Center (UPMC), Pittsburgh, USA

Marc Ribo, MD

Principal Investigator

Vall D'Hebron Hospital, Barcelona, Spain

Eligibility Criteria

Adults aged 18-85 with a recent ischemic stroke due to a large vessel blockage in the brain, who can start treatment within 8 hours of symptom onset. They must have had good health before the stroke, be able to give informed consent, and not be pregnant or breastfeeding. People with severe allergies, recent strokes or surgeries, certain blood disorders, drug abuse, infections like septicemia (except common cold), life expectancy less than 6 months prior to stroke onset are excluded.

Inclusion Criteria

My doctor believes they can start my procedure within 8 hours from when I was last known well.

My stroke imaging shows it's small or not severe based on specific MRI or CT scores.

I have a confirmed blockage in a major brain artery that can be treated with the Millipede System.

Exclusion Criteria

I've been treated with heparin recently and my blood clotting time is high.

I have been diagnosed with inflammation of blood vessels in my brain.

Your blood vessels are too twisty, which may make it difficult to put in the medical device, as shown by special scans or x-rays.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Millipede System for revascularization of acute ischemic stroke due to LVOs

During procedure

1 visit (in-person)

Immediate Follow-up

Participants are monitored for symptomatic intracerebral hemorrhage within 24 hours post-procedure

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Millipede System

Trial Overview The Millipede System is being tested for its effectiveness and safety in reopening blocked vessels in the brain during an acute ischemic stroke. The study will record how well it works and track patients' recovery outcomes.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Millipede System

Millipede System is already approved in European Union, United States for the following indications:

Approved in European Union as Millipede System for:

• Acute ischemic stroke due to Large Vessel Occlusions (LVOs)

Approved in United States as Millipede System for:

• Acute ischemic stroke due to Large Vessel Occlusions (LVOs)

Who Is Running the Clinical Trial?

Perfuze

Lead Sponsor

Trials

1

Recruited

230+

Findings from Research

The PROMISE study, involving 204 patients with large vessel occlusion ischemic stroke, demonstrated that the Penumbra System with ACE68 and ACE64 catheters achieved a high revascularization rate of 93.1% using aspiration thrombectomy within 6 hours of symptom onset.

The treatment was found to be safe, with low rates of serious adverse events (1.5%), symptomatic intracranial hemorrhage (2.9%), and a 90-day mortality rate of 7.5%, indicating that this method is a viable frontline therapy for LVO stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADAPT technique with ACE68 and ACE64 reperfusion catheters in ischemic stroke treatment: results from the PROMISE study. Schramm, P., Navia, P., Papa, R., et al.[2020]

The Aspirex® mechanical thrombectomy system demonstrated a technical success rate of 75% in treating acute infrainguinal arterial thromboembolic occlusions among 24 patients, indicating its effectiveness in revascularizing occluded vessels.

Clinical success was achieved in all patients (100%), with a 1-year limb salvage rate of 95.8%, suggesting that the device is not only effective but also safe for preventing amputations, although caution is advised for use in smaller distal vessels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of infrainguinal arterial thromboembolic acute occlusions with the Aspirex® mechanical thrombectomy device. Teymen, B., Aktürk, S.[2019]

In a study of 27 patients with acute ischemic strokes, the Penumbra system achieved a high recanalization rate of 85%, indicating its effectiveness in restoring blood flow during stroke treatment.

At 3 months, 48% of patients had favorable clinical outcomes (mRS ≤2), and while there were complications such as intracerebral hemorrhage (33.3%), these rates were consistent with existing literature, suggesting the device's safety profile is comparable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with the Penumbra Stroke System for recanalization of large vessel occlusions in acute ischemic stroke. Menon, BK., Hill, MD., Eesa, M., et al.[2021]

The modified Penumbra System (mPS) technique resulted in a significantly higher rate of successful recanalization (85%) compared to the mechanical clot disruption (MCD) technique (32%) in a study of 39 patients with acute distal ICA occlusion.

Patients treated with the mPS technique had better functional outcomes at 3 months, with 45% achieving favorable results compared to only 16% in the MCD group, highlighting the mPS's potential as a more effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of forced-suction thrombectomy in acute intracranial internal carotid occlusion. Hwang, YH., Kang, DH., Kim, YW., et al.[2016]

In a study of 103 patients undergoing mechanical thrombectomy for acute ischemic stroke, the CAT6 aspiration catheter demonstrated a higher placement success rate (98.11%) compared to the 5 Fr Navien catheter (88.00%), indicating better efficacy in achieving successful catheter placement.

The CAT6 group also required fewer additional guidewires (5.66%) compared to the 5 Fr Navien group (13.59%), suggesting that CAT6 may offer a more efficient approach to thrombectomy without compromising safety, as both groups had similar outcomes in terms of 90-day recovery and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Aspiration Catheter CAT6 and 5 Fr Navien in the Endovascular Treatment of Acute Ischemic Stroke. Chen, Z., Fan, T., Zhao, X., et al.[2023]

The Distal Access Catheter has been successfully used with both the Merci Retrieval System and the Penumbra aspiration system, allowing for efficient clot retrieval and aspiration during acute stroke interventions.

Its larger inner diameter may enhance the effectiveness of clot aspiration, potentially improving patient outcomes by saving time in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a distal access catheter in acute stroke intervention with penumbra, merci and gateway. A technical case report. Kalia, JS., Zaidat, OO.[2021]

The Penumbra ACE68 reperfusion catheter significantly reduced the time from puncture to recanalization (26 minutes) compared to previous Penumbra catheters (40 minutes), indicating its efficacy in treating acute ischemic stroke due to internal carotid artery occlusion.

Using the ACE68 catheter also resulted in a lower rate of switching to stent-based retrieval techniques (3% vs. 20%), suggesting it may streamline the treatment process for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Experience of ACE68 Reperfusion Catheter in Patients with Acute Ischemic Stroke Related to Internal Carotid Artery Occlusion. Jang, HG., Park, JS., Lee, JM., et al.[2020]

The Penumbra System is an effective endovascular device for removing blood clots from blocked intracranial vessels using continuous aspiration, which aids in restoring blood flow.

The article reviews both clinical data and institutional experiences to highlight techniques that can enhance the functionality and outcomes of the Penumbra System in thrombectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques and results--penumbra aspiration catheter. Kreusch, AS., Psychogios, MN., Knauth, M.[2012]

References

1. England pubmed.ncbi.nlm.nih.gov

ADAPT technique with ACE68 and ACE64 reperfusion catheters in ischemic stroke treatment: results from the PROMISE study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of infrainguinal arterial thromboembolic acute occlusions with the Aspirex® mechanical thrombectomy device. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Initial experience with the Penumbra Stroke System for recanalization of large vessel occlusions in acute ischemic stroke. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Outcome of forced-suction thrombectomy in acute intracranial internal carotid occlusion. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Aspiration Catheter CAT6 and 5 Fr Navien in the Endovascular Treatment of Acute Ischemic Stroke. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Using a distal access catheter in acute stroke intervention with penumbra, merci and gateway. A technical case report. [2021]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Initial Experience of ACE68 Reperfusion Catheter in Patients with Acute Ischemic Stroke Related to Internal Carotid Artery Occlusion. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Techniques and results--penumbra aspiration catheter. [2012]