What side effects are associated with this type of intervention?

The most common side effects of extracranial proximal carotid artery acute stenting, a treatment used to restore blood flow in stroke patients, include bleeding at the puncture site, infection, and vessel injury. Other potential complications are restenosis (re-narrowing of the artery), stroke during the procedure, and adverse reactions to contrast dye used in imaging. Additionally, patients may experience transient ischemic attacks (TIAs) or minor strokes post-procedure. These side effects are generally manageable but require careful monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, particularly focusing on mechanical thrombectomy and stenting. Mechanical thrombectomy devices, such as the Solitaire and Trevo stent retrievers, have been approved for the treatment of acute ischemic stroke caused by large vessel occlusions. These devices work by physically removing the clot from the blocked artery, thereby restoring blood flow. Additionally, carotid artery stenting (CAS) has been approved for patients with carotid artery stenosis, which involves placing a stent to open up the narrowed artery and prevent future strokes. These treatments are crucial for patients with acute ischemic stroke and severe carotid artery disease, as they help to quickly restore blood flow and reduce the risk of further complications.

What other types of research exist?

Promising novel alternatives to extracranial proximal carotid artery acute stenting for stroke patients include intra-arterial mechanical thrombectomy (MT) and transcranial direct current stimulation (tDCS). Mechanical thrombectomy is effective for removing clots in intracranial vessel occlusions, while tDCS is being explored for its potential to improve neurological outcomes post-stroke.

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Mechanical Thrombectomy Device

Thrombectomy + Angioplasty/Stenting for Stroke (PICASSO Trial)

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

Must not have

Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test

Intracranial tumors other than small meningioma that does not require surgery for one year post randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: 90 days post randomization

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if using a stent to open a blocked neck artery along with removing a brain clot is better than just removing the clot alone for stroke patients with severe artery blockages.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or have a negative pregnancy test if of child-bearing age.

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I have a brain tumor, but it's not a meningioma needing surgery within a year.

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My high blood pressure is not controlled by medication.

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I have a bleeding disorder or am on blood thinners with high INR or PTT levels.

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I cannot take certain blood thinners or contrast dyes due to adverse reactions.

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My narrowed neck artery is due to a tear or inflammation.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

90-day Modified Rankin Scale ordinal shift

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for stroke, particularly those involving mechanical thrombectomy and stenting, work by physically removing or bypassing the blockage in the blood vessels. Mechanical thrombectomy involves using specialized devices to extract the clot from the occluded artery, while stenting involves placing a small mesh tube to keep the artery open. These treatments are crucial as they restore blood flow to the affected areas of the brain, minimizing the extent of brain damage and improving the chances of recovery. Timely restoration of blood flow is essential to prevent irreversible brain injury and improve functional outcomes for stroke patients.

Complete occlusion of the proximal subclavian artery post-CABG: presentation and treatment.