Adjustable Low-profile Stentriever for Ischemic Stroke

(DISTALS Trial)

Recruiting at 21 trial locations

Overseen By Walid Haddad, Dr.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rapid Medical

Must not be taking: Oral anticoagulants, Heparin, DOACs

Disqualifiers: Acute brain hemorrhage, Renal failure, 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

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Tigertriever 13, designed to restore blood flow in people who have had an ischemic stroke. The researchers aim to determine if this device removes blood clots more effectively than standard medical care. Participants are divided into two groups: one receives treatment with the device, and the other receives standard medical management. This trial may suit individuals who have experienced a stroke that significantly affects daily activities, such as walking or eating, due to a blocked small blood vessel in the brain. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance stroke treatment options.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on oral anticoagulant therapy with an INR over 1.7, have been treated with heparin within 48 hours, or have taken a direct oral anticoagulant (DOAC) within 48 hours.

What prior data suggests that the Tigertriever 13 Revascularization Device is safe for ischemic stroke patients?

Research has shown that the Tigertriever 13 device is generally safe for treating ischemic stroke. In earlier studies, serious complications such as bleeding in the brain and death occurred in 18.1% of cases, which is lower than the 30.4% seen with similar treatments. Another study found that using the Tigertriever 13 for blockages in smaller blood vessels is safe and effective, with results similar to those for larger vessel blockages.

Overall, the Tigertriever 13 meets safety standards, and past use suggests it is well-tolerated. While risks always exist, the evidence supports its safety for this specific use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tigertriever 13 because it offers a new approach to treating ischemic stroke. Unlike traditional treatments that rely on clot-dissolving drugs, the Tigertriever 13 uses a mechanical thrombectomy technique. This device is a low-profile stentriever designed to physically remove the clot causing the stroke, potentially offering faster and more effective results. Its adjustable design allows for greater precision and adaptability during the procedure, which could lead to better outcomes for patients who can't receive thrombolysis.

What evidence suggests that the Tigertriever 13 Revascularization Device is effective for ischemic stroke?

Research has shown that the Tigertriever 13 device, which participants in this trial may receive, effectively treats strokes caused by clots in smaller blood vessels. Studies indicate it can safely remove these clots and restore blood flow. One study found a high success rate in restoring blood flow with this device, highlighting its effectiveness. Tests confirm that the device meets important performance standards. These findings suggest that Tigertriever 13 is a promising option for improving outcomes in patients with certain types of strokes. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with a recent ischemic stroke causing significant disability, who can't receive standard clot-dissolving drugs. They must have had symptoms start within the last 24 hours and not be pregnant or breastfeeding. Participants need to have certain levels of stroke severity and brain imaging findings, but cannot join if they've had another stroke treatment first or have conditions like severe allergies to metals used in the device.

Inclusion Criteria

I was mostly independent before my stroke.

Signed informed consent by patient or legally authorized representative

You have a score between 4 and 24 on the NIH Stroke Scale, or a score between 2 and 24 if you have trouble speaking or seeing.

Exclusion Criteria

I have taken a blood thinner pill in the last 2 days.

I currently have an infection that affects my whole body.

I do not have a brain tumor larger than 2 cm, except for a small meningioma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive mechanical thrombectomy with Tigertriever 13 EVT or medical management alone

During procedure

1 visit (in-person)

Immediate Follow-up

Participants are monitored for successful reperfusion and adverse events within 24±6 hours post randomization

24±6 hours

Extended Follow-up

Participants are assessed for cognitive function, global disability, and quality of life at 90 days post randomization

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Tigertriever 13

Trial Overview The DISTALS Study tests the Tigertriever 13 Device's ability to remove blood clots from smaller brain vessels in patients with disabling strokes compared to usual medical care. The goal is to see if this new device can improve blood flow better than current treatments when started within a day of symptom onset.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis).

Group II: Control Active Control 1 Intervention

Medical Management alone (without thrombolysis).

Tigertriever 13 is already approved in European Union, United States for the following indications:

Approved in European Union as Tigertriever 13 Revascularization Device for:

• Ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO)
• Large intracranial vessel occlusion in ischemic stroke

Approved in United States as Tigertriever 13 Revascularization Device for:

• Ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO)
• Large intracranial vessel occlusion in ischemic stroke

Who Is Running the Clinical Trial?

Rapid Medical

Lead Sponsor

Trials

7

Recruited

1,400+

Published Research Related to This Trial

In a study of 140 patients treated for large vessel occlusion, the Tigertriever stent-retriever demonstrated a significantly higher successful first pass revascularization rate (46% vs. 23%) and a shorter groin-to-revascularization time (51 minutes vs. 65 minutes) compared to other stent-like devices.

There were no significant differences in long-term outcomes or adverse events between the Tigertriever and other stent-like stent-retrievers, indicating that Tigertriever is a safe and effective option for mechanical thrombectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy of large vessel occlusion using adjustable vs. self-expanding stent-retriever-Comparison of Tigertriever device with stent-like stent-retrievers: A propensity score analysis. Piasecki, P., Wierzbicki, M., Narloch, J., et al.[2023]

The study evaluated the effects of bionator therapy on Class II division 1 patients, showing significant transverse growth of the maxilla and mandible after treatment, based on measurements taken before, immediately after, and 5.74 years post-treatment.

The only area that did not exhibit transverse growth was the anterior maxillary region, indicating that while bionator therapy is effective for most areas, it may have limitations in promoting growth in the front part of the maxilla.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transverse maxillary and mandibular growth during and after bionator therapy: study with metallic implants. Monini, Ada C., Júnior, LG., Maia, LG., et al.[2019]

In the TIGER trial involving 160 patients, the Tigertriever device achieved successful reperfusion in 78% of patients with large vessel occlusion and underlying intracranial atherosclerotic disease, demonstrating its efficacy in this challenging patient population.

The use of the Tigertriever device was safe, with no device-related complications reported, and it resulted in a significant reduction in stroke severity as measured by the NIHSS score, from an average of 17 at baseline to 8 at 24 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tigertriever in the treatment of acute ischemic stroke with underlying intracranial atherosclerotic disease. Ojeda, DJ., Ghannam, M., Sanchez, S., et al.[2023]

In a study involving 23 patients with acute terminal ICA occlusions, the Tigertriever XL Device achieved a successful reperfusion rate of 78.3% after a median of two maneuvers, and a final rate of 95.7% when additional devices were used.

The device showed no complications related to its use, although there were two cases of symptomatic intracerebral hemorrhage, suggesting it is a safe and effective option for treating large clots in cerebral vessels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical Thrombectomy in Acute Terminal Internal Carotid Artery Occlusions Using a Large Manually Expandable Stentretriever (Tiger XL Device): Multicenter Initial Experience. Maus, V., Hüsken, S., Kalousek, V., et al.[2021]

The Balters bionator effectively produces long-term favorable changes in mandibular shape for growing patients with Class II malocclusion, as shown by morphometric analysis of 23 treated patients over an average follow-up of 8 years.

In contrast, a control group of 22 untreated patients showed no significant improvements in their Class II malocclusion, highlighting the bionator's efficacy in correcting dentoskeletal imbalances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphometric analysis of long-term dentoskeletal effects induced by treatment with Balters bionator. Bigliazzi, R., Franchi, L., Bertoz, AP., et al.[2022]

The Tigertriever device was used in a study involving 30 patients with acute ischemic stroke, showing a high recanalization rate of 94%, indicating its effectiveness in restoring blood flow.

The first-pass effect was observed in 24% of cases, and patients had a favorable median modified Rankin Scale (mRS) score of 1 at 90 days, suggesting good functional outcomes and safety of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy using the new Tigertriever in acute ischemic stroke patients - A Swiss prospective multicenter study. Gruber, P., Diepers, M., von Hessling, A., et al.[2021]

In a study involving 96 participants aged 12-18 with moderate to severe crowding, superelastic NiTi wires significantly outperformed multistranded stainless steel wires in reducing crowding when used in the Begg appliance, especially in cases of severe crowding.

However, there was no significant difference in crowding reduction between the two wire types when used in the preadjusted edgewise appliance (PEA), indicating that the choice of wire may be more critical in certain orthodontic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency, behavior, and clinical properties of superelastic NiTi versus multistranded stainless steel wires: a prospective clinical trial. Sandhu, SS., Shetty, VS., Mogra, S., et al.[2022]

The Tigertriever, an adjustable-diameter stent retriever, was successfully used in a case of a 59-year-old woman with a right internal carotid artery occlusion, leading to effective reperfusion without any perioperative complications.

The adjustable design of the Tigertriever allows it to be tailored to the specific diameter of the target artery, which may enhance its effectiveness in treating distal vessel occlusions during mechanical thrombectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of expandable stent retriever for mechanical thrombectomy of the right internal carotid artery terminus occlusion. Dossani, RH., Waqas, M., Rai, HH., et al.[2022]

In a study of 89 patients undergoing transcatheter aortic valve replacement (TAVR) with the SAPIEN XT valve, low implantation depth was linked to a higher risk of new conduction disturbances and the need for permanent pacemaker implantation.

The study found that while low implantation depth affected heart conduction, the size and expansion of the valve did not lead to similar complications, suggesting that careful positioning of the valve is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of post-implant SAPIEN XT geometry and position on conduction disturbances, hemodynamic performance, and paravalvular regurgitation. Binder, RK., Webb, JG., Toggweiler, S., et al.[2014]

In a study of 281 patients undergoing TAVI with the Edwards SAPIEN S3 device, direct TAVI was found to be feasible and safe, with procedural success achieved in all cases, including those with moderate aortic valve calcification.

For patients with high calcium burden, selective predilation is recommended, as it may reduce the risk of device malposition, although both predilation and direct TAVI showed similar mortality rates at 30 days and 1 year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Systematic Predilation, Selective Predilation, and Direct Transcatheter Aortic Valve Implantation With the SAPIEN S3 Valve. Spaziano, M., Sawaya, F., Chevalier, B., et al.[2018]

The meta-analysis of transcatheter aortic valve implantation (TAVI) devices showed that the ACURATE neo valve resulted in significantly fewer cases of new permanent pacemaker implantation compared to both the SAPIEN 3 and EVOLUT R/PRO valves, indicating a potential safety advantage.

Conversely, the SAPIEN 3 valve was associated with a significantly lower occurrence of moderate to severe paravalvular leak compared to the ACURATE neo valve, suggesting it may provide better efficacy in preventing this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the new generation transcatheter aortic valve in the real life studies. Review and meta-analysis. Acconcia, MC., Caretta, Q., Monzo, L., et al.[2020]

In a study of 48 patients with deep overbite, treatment with metal anterior bite turbos (ABTs) resulted in a shorter duration of overbite correction by 1.7 months compared to treatment with lower reverse curve of Spee archwire (LRCA).

The LRCA treatment led to significant lower incisor proclination and distal tipping of lower molars, while ABTs caused more extrusion of lower posterior teeth, indicating different mechanisms of action for each treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study between the effect of reverse curve of Spee archwires and anterior bite turbos in the treatment of deep overbite cases. Al-Zoubi, EM., Al-Nimri, KS.[2022]

The Balters bionator significantly improved the shape and position of the mandible in 31 growing patients with Class II malocclusion, demonstrating effective treatment over an average of 2 years and 2 months.

In contrast, a control group of 22 untreated patients showed no significant changes in their Class II malocclusion, highlighting the bionator's efficacy in correcting mandibular retrusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphometric analysis of treatment effects of the Balters bionator in growing Class II patients. Antunes, CF., Bigliazzi, R., Bertoz, FA., et al.[2022]

The transcarotid (TC) approach for transcatheter aortic valve replacement (TAVR) using the Edwards Sapien 3 device demonstrated a high procedural success rate of 97% in a study of 314 patients, suggesting it is a viable alternative for those ineligible for transfemoral access.

At 30 days post-procedure, TC-TAVR showed a 3.2% mortality rate and low rates of major complications, including 4.1% major bleeding and 1.6% stroke, indicating that it is a safe option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcarotid Approach for Transcatheter Aortic Valve Replacement With the Sapien 3 Prosthesis: A Multicenter French Registry. Overtchouk, P., Folliguet, T., Pinaud, F., et al.[2020]

Surgical aortic valve replacement (SAVR) significantly improves survival and quality of life in patients with severe aortic stenosis compared to medical therapy, as shown in the randomized PARTNER Trial.

Transcatheter Aortic Valve Replacement (TAVR) has been successfully performed on 56 patients at Rhode Island Hospital, yielding outcomes comparable to those in the PARTNER Trial, and is being explored for use in intermediate-risk patients with advancements in valve technology aimed at reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement: a review of current indications and outcomes. Prabhu, W., Gordon, PC.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12141254/

Role of Tigertriever13 for distal medium vessel occlusion T13 for MT seems to be safe and effective for DMVO. Clinical outcomes and complications were in line with those described among patients with proximal ...

2. jnis.bmj.com jnis.bmj.com/content/14/Suppl_1/A13.2

O-020 The tigertriever 13 distals study DISTALS is a randomized study planned to evaluate the safety and effectiveness of the TIGERTRIEVER 13 Revascularization Device in restoring blood flow in the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05152524

Distal Ischemic Stroke Treatment With Adjustable Low- ... Successful reperfusion (eTICI ≥2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only).

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.121.034436

New Class of Radially Adjustable Stentrievers for Acute ... The primary TIGER Study hypothesis was that the Tigertriever device would achieve successful reperfusion performance within 3 attempts would be ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K220808.pdf

July 25, 2022 Rapid Medical Ltd. Janice Hogan Partner ... Results of the performance bench testing indicate that Tigertriever 13 Revascularization device meets established performance requirements ...