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Angioplasty for Stroke Risk Reduction
Study Summary
This trial will study whether a minimally-invasive endovascular intervention can be performed safely in patients with a high risk of stroke due to atherosclerosis, as well as its effect on stroke risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I need blood thinners for a clot or irregular heartbeat beyond joining the study.I do not have any brain or nerve conditions that could affect my study results.I am allergic to or cannot take aspirin or Plavix.I have a heart condition that increases my risk of blood clots.I have experienced symptoms within the last 30 days.I have a blood disorder such as polycythemia vera, essential thrombocytosis, or sickle cell disease.You cannot have a test called cerebral angiography.My arteries are not too twisted or blocked to reach the target area for treatment.I had a mild stroke within the last month due to a narrowed brain artery.You have low blood flow, as determined by a specific test used in the VERiTAS Study.The narrow section in the blood vessel is less than 18mm long.I do not have a health condition that limits my life expectancy to less than 12 months.I am 30-49 years old with atherosclerosis or have 2+ risk factors like high blood pressure, diabetes, high cholesterol, or recent tobacco use.I have had a severe stroke that significantly affects my daily activities.I have poor blood flow in my brain due to narrowed arteries.I have not had clot-dissolving therapy in the last 24 hours.My blood vessel narrowing is not due to hardening of the arteries.I don't have active bleeding, recent major bleeding, severe stomach ulcers, very low platelets, or severe liver problems.The blood vessel being treated needs to be at least 2mm wide.I am between 30 and 90 years old.My blood vessel narrowing is complex and previously treated with a device.I had a bleeding stroke confirmed by CT scan within the last 14 days.I had a large stroke that could lead to bleeding in the brain.I cannot or do not want to have an MRI scan.You had a specific type of stroke called a borderzone infarct as defined by SAMMPRIS cohort analysis.
- Group 1: Submaximal balloon angioplasty plus intensive medical therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there an age restriction for participation in this clinical trial?
"The age range for this particular medical trial is set between 30 and 90 years old. Additionally, there are 59 studies offering treatment to patients below 18 while 1219 trials are available to those above 65."
May I partake in this research initiative?
"This clinical trial requires 159 participants aged between 30 and 90 that are presently suffering from hemodynamics. In order to be accepted, individuals must also meet the following criteria: having survived a non-severe stroke within the past month attributed to stenosis of an intracranial artery (internal carotid, middle cerebral, vertebral or basilar) verified by CTA (or DSA if available); target length of stenosis below 18mm; sole or predominant borderzone infarct pattern for qualifying event; low flow state as determined by optimized flow algorithm per VERiTAS Study requirements; hemodynamic compromise resulting from aforesaid border"
Is the enrollment of participants open for this medical experiment?
"According to clinicaltrials.gov, this study is not recruiting participants at the moment as its most recent update was on October 6th 2022 and it had been initially posted on June 1st 2023. Nevertheless, there are still 1263 other trials with open enrollment currently available."
What beneficial results is this experiment seeking to achieve?
"This trial, which will run for a month's time, is primarily focused on assessing procedural safety. Secondary aims include evaluating hemodynamic durability (sustained improvement of blood flow in the treated vessel/territory), clinical efficacy (periprocedural stroke/death and subsequent strokes within the symptomatic area at one year) and hemodynamic success (improvement of blood flow in the affected region)."
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