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Mechanical Thrombectomy Device

Thrombectomy + Angioplasty/Stenting for Stroke (PICASSO Trial)

Q: Does this research project enlist volunteers who are aged seventy or older?

<p>Based on the eligibility requirements listed, it appears that this study is for patients aged 18 to 85. In contrast, there are 42 trials for people under the age of 18 and 1088 for patients over 65.</p>

Q: Does the BMM+/-IAT+CAT procedure pose any risks for patients not undergoing stenting?

<p>BMM+/-IAT+CAT without stenting has been proven to be efficacious and safe in multiple rounds of clinical trials, thus it received a score of 3.</p>

Phase 3

Recruiting

Led By Osama O Zaidat, MD, MS

Research Sponsored by Mercy Health Ohio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-stroke mRS score 0-2

Presenting with symptoms consistent with AIS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: 90 days post randomization

Awards & highlights

PICASSO Trial Summary

This trial tests 2 treatments for stroke caused by blocked arteries in the brain. It compares thrombectomy with angioplasty and acute stenting to treat stroke.

Who is the study for?

This trial is for adults aged 18-85 who've had a stroke within the last 24 hours due to a blockage in the arteries of the brain and neck. They should have moderate to severe symptoms but still be relatively independent before the stroke, with no major health issues that would interfere with treatment or reduce life expectancy below one year.Check my eligibility

What is being tested?

The study tests if removing clots from brain arteries (mechanical thrombectomy) combined with immediate stenting of blocked neck arteries is better than clot removal alone. Patients are randomly assigned to either get a stent plus antiplatelet drugs by mouth or IV, or just standard care after clot removal.See study design

What are the potential side effects?

Possible side effects include risks associated with blood thinners like bleeding, allergic reactions to contrast media used during imaging, complications from balloon angioplasty such as artery damage, and general risks from endovascular procedures like infection.

PICASSO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was mostly independent before my stroke.

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I am experiencing symptoms similar to a minor stroke.

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I can start the trial within a day of having a stroke.

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I have a blockage in the main arteries of my brain that needs treatment.

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I received medical intervention within 25 hours of my stroke symptoms starting.

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I have a blockage in my neck artery and possibly in my brain.

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I am between 18 and 85 years old.

PICASSO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: 90 days post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: 90 days post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: 90 days post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

90-day Modified Rankin Scale ordinal shift

PICASSO Trial Design

2Treatment groups

Experimental Treatment

Group I: MT+CATExperimental Treatment1 Intervention

Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion angioplasty or aspiration (MT+CAT)

Group II: MT+CASExperimental Treatment2 Interventions

Acute carotid stenting (ACS) approach constitutes BMM+IAT with acute carotid stenting (ACS) of the extracranial proximal carotid artery, spanning the cervical internal carotid artery (ICA), ICA origin, and the distal common carotid artery (CCA, across the bifurcation) as in the example of left (L) carotid stenting figure below (MT+CAS). Within the stenting arm, there will be 2 different subgroups based on the antiplatelet treatment protocol per the site standard of care (oral antiplatelet or IV antiplatelet medication (e.g., Cangrelor or others).

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mercy Health OhioLead Sponsor

14 Previous Clinical Trials

1,201 Total Patients Enrolled

1 Trials studying Stroke

300 Patients Enrolled for Stroke

Osama O Zaidat, MD, MSPrincipal InvestigatorMercy Health St. Vincent Medical Center

4 Previous Clinical Trials

950 Total Patients Enrolled

2 Trials studying Stroke

800 Patients Enrolled for Stroke

Media Library

Intra-arterial Therapy (Mechanical Thrombectomy Device) Clinical Trial Eligibility Overview. Trial Name: NCT05611242 — Phase 3

Stroke Research Study Groups: MT+CAS, MT+CAT

Stroke Clinical Trial 2023: Intra-arterial Therapy Highlights & Side Effects. Trial Name: NCT05611242 — Phase 3

Intra-arterial Therapy (Mechanical Thrombectomy Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05611242 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To date, how many people have agreed to be a part of this experiment?

"That is correct. The clinical trial is currently looking for patients. The original posting was on November 1st, 2022 and the last edit was on November 2nd, 2022. A total of 404 patients are needed for the study taking place at 1 site."

Answered by AI

Does this clinical trial have any age, weight, or health prerequisites?

"This study is looking for 404 participants that have had a cerebrovascular accident, are aged 18 to 85, and meet the following criteria: Arterial Access Obtained < 25 hours from stroke symptoms onset., 18 to 85 years of age, Presenting with symptoms consistent with AIS, Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis requiring treatment on non-in"

Answered by AI

Does this research project enlist volunteers who are aged seventy or older?

"Based on the eligibility requirements listed, it appears that this study is for patients aged 18 to 85. In contrast, there are 42 trials for people under the age of 18 and 1088 for patients over 65."

Answered by AI