New balloon procedure could prevent stroke in High-Risk patients
NCT ID NCT03729817
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a procedure called submaximal balloon angioplasty to improve blood flow in narrowed brain arteries and prevent stroke. It involves 159 people who recently had a mild stroke due to severe artery narrowing (70-99%). The procedure uses a small balloon inflated to a smaller size than the normal artery to widen the vessel. The goal is to see if it is safe and works well enough to plan a larger trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- submaximal balloon angioplasty
- What this could lead to
- If successful, this procedure could offer a new treatment option to prevent stroke in patients with intracranial artery narrowing who have no other options.
- What could go wrong
- This is an early-stage safety and feasibility study with only 159 participants. The procedure carries risks of stroke or death, and it may not prove effective or durable.
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
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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
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About 159 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2027
An estimate. Start dates often move.
- Expected to finish
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Oct 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 90 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Non-severe recent stroke (within 30 days) attributed to 70-99% stenosis of intracranial artery (internal carotid, middle cerebral, vertebral, basilar); must be confirmed by CTA (or DSA if already available) for enrollment into the trial. * Hemodynamic compromise based on borderzone infarct pattern\* for the anterior circulation (internal carotid and middle cerebral artery stenosis) and by low flow state on QMRA\*\* for the posterior circulation (vertebral and basilar artery stenosis). * Target vessel with minimal nominal diameter of 2mm * Target length of stenosis \<18mm * Symptoms within 30 days of enrollment * Age ≥30 and ≤90 years old# * Able to provide informed consent * \*Sole or predominant borderzone infarct pattern of qualifying event, as defined by SAMMPRIS cohort analysis \*\*Low flow state as determined by optimized flow algorithm as defined by the VERiTAS Study * #Those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years). Exclusion: * Major disabling stroke mRS \>3; progressive or fluctuating deficit within 24 hours * Hemorrhagic infarction (based on CT) within 14 days of enrollment * Any large stroke (\>5cm) to be at risk for hemorrhagic conversion * Any neurological disease which would confound follow-up assessment * Any co-morbid disease condition with \<12 month life expectancy * Known cardiac disease associated with elevated cardioembolic risk, specifically, atrial fibrillation, prosthetic valve, endocarditis, left atrial/ventricular thrombus, cardiomyopathy with EF\<25%, cardiac myxoma * Blood dyscrasias, specifically polycythemia vera, essential thrombocytosis, sickle cell disease * Active bleeding diathesis, h/o major systemic hemorrhage within 30 days, active PUD, platelets\<100K (severe liver impairment (AST or ALT\>3 x normal, cirrhosis) * Non-atherosclerotic stenosis including dissection, fibromuscular dysplasia, vasculitis, radiation induced vasculopathy, suspected recanalized embolus, suspected vasospastic process * Mori C classification of stenosis (i.e. diffuse lesion, extremely angulated \>90⁰, excessive proximal tortuosity) Previous treatment of target lesion with stent, angioplasty or other mechanical device * Extracranial vertebral artery or carotid artery tortuosity, stenosis or occlusion prohibiting access to the target lesion (not exclusionary if does not prohibit access to target lesion) * Unable or unwilling to undergo MRI * Unable to undergo cerebral angiography * Pregnancy * Concurrent participation in another study which would conflict with the current study * Allergy or contraindication to aspirin or Plavix * Indication for warfarin or NOAC beyond enrollment (e.g. venous thrombo-embolism, atrial fibrillation) * Thrombolytic therapy within 24 hours
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Case Western Reserve University
Cleveland, Ohio, 44106, United States
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Other studies related to the condition(s) this trial covers.
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