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New device aims to pull clots from the brain in major strokes

NCT ID NCT06249776

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study tested a new device called the Supernova stent retriever in 55 people with severe stroke caused by a large blood clot in the brain. The device is threaded through blood vessels to grab and remove the clot, restoring blood flow. Researchers measured how often blood flow was successfully restored and checked for serious side effects like bleeding in the brain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Supernova stent retriever device (mechanical thrombectomy)
What this could lead to
If successful, this device could offer a new option to quickly remove blood clots and restore blood flow in people having a severe stroke.
What could go wrong
This was a small, early study with only 55 participants. The device may not work better than existing treatments, and there are risks like bleeding in the brain or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

55 people

The number who actually took part.

Started

Feb 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. New focal neurologic deficit consistent with being of acute cerebral ischemia origin. 2. Age 18-85 years old (inclusive). 3. Interventionalists estimate that treatment with the Supernova (first deployment in target vessel) can be achieved within 24 hours of symptom onset. 4. Intravenous thrombolysis may be given as per national guidelines and patients receiving or not receiving intravenous thrombolysis will both be eligible for inclusion in the study. 5. Admission NIH Stroke Scale score of 8-25 6. No known significant pre-stroke disability (pre-stroke mRS 0 or 1). 7. Catheter angiographic confirmation of large vessel occlusion in the intracranial internal carotid artery, the M1 or M2 segments of the middle cerebral artery, or the basilar artery that is accessible to the Supernova device. 8. For strokes in the anterior circulation, the following imaging criteria should also be met: 1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR 2. CT criterion: ASPECTS 6 to 10 on baseline NCCT 9. Anticipated life expectancy of at least 6 months. 10. A signed informed consent by the patient or a Legally Authorized Representative or independent physician in case of oral consent. Exclusion Criteria: 1. Subject already participating in another study of an investigational treatment device or treatment. 2. Use any other intra-arterial recanalization drug or device prior to the use of Supernova (Supernova is not the first-choice device). 3. Angiographically evident excessive arterial tortuosity precluding device access to the thrombus. 4. For all patients, severe sustained hypertension with SBP \>220 and/or DBP \>120; for patients treated with IV tPA, sustained hypertension despite treatment with SBP \>185 and/or DBP \> 110. 5. Glucose \< 50 mg/dl (2.78 mmol/L) or \> 400 mg/dl (22.20 mmol/L). 6. Known hemorrhagic diathesis. 7. Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.0. 8. Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal. 9. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible. 10. Platelet count of less than 50,000/ µL. 11. History of severe allergy to contrast medium, nickel, or Nitinol. 12. Intracranial hemorrhage. 13. Significant mass effect with midline shift. 14. Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter). 15. Stenosis or any occlusion in the deployment site or in a proximal vessel requiring treatment or preventing device access to the thrombus (for example, stenosis or occlusion in the cervical internal carotid artery or common carotid artery). 16. Presence of intracranial atherosclerotic disease requiring rescue therapy (for example, intracranial stenting). 17. Females who are pregnant or breastfeeding. 18. Known current use of narcotic drugs at the time of treatment. 19. Prior recent stroke in the past 3 months. 20. Renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30. 21. Known cerebral vasculitis. 22. Rapidly improving neurological status defined as the improvement of greater than 8 points on the NIHSS or improvement to NIHSS of \< 6 prior to the procedure. 23. Clinical symptoms are suggestive of bilateral stroke or stroke in multiple territories. 24. Ongoing seizure due to stroke. 25. Evidence of active systemic infection. 26. Known cancer with metastases. 27. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis. 28. Evidence of dissection in the extra or intracranial cerebral arteries. 29. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation or anterior/posterior circulation). 30. Aneurysm in the target vessel.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • All India Institute of Medical Sciences, New Delhi

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Apollo Hospitals

    Hyderabad, Telangana, 500096, India

  • Dr Balabhai Nanavati Hospital

    Mumbai, Maharashtra, 400056, India

  • Jawaharlal Institute of Postgraduate Medical Education and Research

    Puducherry, Puducherry, 605006, India

  • Marengo CIMS Hospital

    Ahmedabad, Gujarat, 380060, India

  • National Institute of Cardiovascular Diseases

    Karachi, Sindh, 75510, Pakistan

  • P.D. Hinduja Hospital and Medical Research Centre

    Mumbai, Maharashtra, 400016, India

  • Tehran University of Medical Sciences

    Tehran, Tehran Province, 1416753955, Iran

  • The Calcutta Medical Research Institute

    Kolkata, West Bengal, 700027, India

  • Yashoda Hospitals, Secunderabad

    Hyderabad, Telangana, 500082, India

  • Yashoda Hospitals, Somajiguda

    Hyderabad, Telangana, 500082, India

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