Surgical Procedures for Stroke

(STAR Trial)

Recruiting at 69 trial locations

Overseen By Meredith Robinson, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

40000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information from individuals undergoing surgery for specific brain injuries. It focuses on conditions such as blocked blood flow in the brain, aneurysms (ballooning arteries), and tangled or malformed blood vessels. The goal is to compare various surgical techniques and devices specific to stroke, thrombectomy, and aneurysm procedures to determine which are most effective. Individuals scheduled for surgery for these specific brain issues may be suitable candidates for this trial. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these surgical techniques and devices are safe for treating brain injuries?

Research has shown that mechanical thrombectomy, a procedure to remove clots from brain blood vessels, is generally well-tolerated. Some studies report death rates below 30%, though certain stroke types can result in higher rates. Serious side effects, such as brain bleeding or worsening symptoms, occurred in a few cases.

For aneurysm surgeries, data indicates these procedures are quite safe, especially for unruptured aneurysms. In studies that found the surgeries safe, in-hospital death rates did not exceed 5%. It is important to remember that these numbers are based on past patients and may not predict individual experiences.

Overall, while these procedures carry risks, studies have shown they are safe for many people. Always consult a healthcare provider to understand how this might relate to individual circumstances. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stroke Thrombectomy and Aneurysm Registry because it explores advanced surgical techniques that could significantly improve outcomes for stroke and aneurysm patients. Unlike traditional approaches that often rely on medication or less targeted interventions, these procedures directly remove or address the problematic blood clots or aneurysms. This direct approach may lead to faster recovery times and reduced long-term brain damage. By refining these surgical techniques, the trial aims to enhance precision and effectiveness, offering hope for better survival rates and quality of life for patients affected by these serious conditions.

What evidence suggests that this trial's treatments could be effective for brain injuries?

Research has shown that endovascular thrombectomy, one of the procedures studied in this trial, can reduce disability in people who have had an ischemic stroke. Specifically, studies found that 50.5% of patients improved in their neurological condition, and 79.6% experienced successful restoration of blood flow. For aneurysm surgeries, another procedure under investigation, 81.2% of patients without fluid build-up in the brain (hydrocephalus) had good outcomes. The surgical techniques for treating unruptured aneurysms proved safe, with low in-hospital death rates. Overall, these procedures have demonstrated promising results in improving patient health. ^{1 2 6 7 8}

Who Is on the Research Team?

Meredith Robinson, MS

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

Inclusion Criteria

Undergoing surgical intervention for central nervous system vascular lesion

Between 1 and 120 years of age

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical procedures for treatment of brain injuries such as thrombectomy or aneurysm repair

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of hemorrhage, occlusion, complication, and retreatment rates

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stroke/Thrombectomy/Aneurysm-specific surgical procedures

How Is the Trial Designed?

Group I: Thrombectomy Experimental Treatment 1 Intervention

Group II: Stroke Experimental Treatment 1 Intervention

Group III: Aneurysm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11043903/

Cerebral Aneurysm Characteristics and Surgical Outcomes This comprehensive study analyzes 346 surgically treated intracranial aneurysms, emphasizing the importance of understanding risk factors and prevalent ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809065

Outcomes Associated With Intracranial Aneurysm ... In studies claiming a technique was safe to use in unruptured aneurysms, the maximum proportion of patients with in-hospital mortality was 5%; ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.118.023771

Prediction of Outcomes for Ruptured Aneurysm Surgery Favorable outcome was achieved in 65.7% of patients with hydrocephalus, compared with 81.2% of patients without hydrocephalus (χ2=15.1, P<0.001) ...

4. jnis.bmj.com jnis.bmj.com/content/16/4/365

Cerebral aneurysms: Germany-wide real-world outcome data ... This cohort study analyzed all EVT and clipping procedures for IAs in Germany between 2007 and 2019. The data basis was the billing-data of all German ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772529424005873

An overview of decision-making in cerebrovascular ... A multicenter surgical series with 228 small aneurysms reported no changes in functional outcomes after clipping, permanent neurological morbidity was noted in ...

6. ahajournals.org ahajournals.org/doi/10.1161/STR.0000000000000070

Guidelines for the Management of Patients With ... IAs are acquired lesions and are the cause of most cases (80%–85%) of nontraumatic SAH; however, the proportion of IAs that rupture is unknown.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10474558/

Outcomes Associated With Intracranial Aneurysm Treatments ... In studies claiming a technique was safe to use in unruptured aneurysms, the maximum proportion of patients with in-hospital mortality was 5%; ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S221475192030579X

Efficacy and safety of surgical treatment for middle cerebral ... This study demonstrated that surgical treatment for middle cerebral artery aneurysms is safe and effective. In the overall analysis, ruptured aneurysms ...