Clinical Trial Evaluates Efficacy and Safety of Thrombectomy in Patients With Larger Stroke

S & P based on the results of the research published today in JAMA Neurology Endovascular thrombectomy may be beneficial for patients with more severe ischemic events. A multicenter, international Phase III clinical trial will begin at the University of Texas Health Sciences Center in Houston (UTHealth).

The trial, called SELECT2 (Optimizing Patient Selection for Endovascular Treatment in Cases of Acute Ischemic Stroke), is a randomized, controlled, open, blinded trial for the evaluator, who evaluates the efficacy and safety of thrombectomy in patients with more severe ischemic stroke.

Although several previous clinical trials have shown that endovascular thrombectomy is safe and beneficial for patients with smaller lesions due to ischemic stroke, the safety and potential benefits of larger strokes remain unknown. .

Ischemia refers to the restriction of blood supply to the tissues. In ischemic stroke, a clot blocks blood flow into a cerebral artery, thereby preventing oxygen from reaching the surrounding brain tissue and causing cell death. This zone of cell death is called an ischemic nucleus.

In endovascular thrombectomy, a small catheter is guided through an artery, usually a femoral artery, through the body to the site of blockage in the brain. A device for removing blood clots is deployed and captures the clot. The catheter is then retracted.

The previous Phase II clinical trial (SELECT), which included patients in nine full-length stroke centers in the United States, included 105 patients with large ischemic nuclei. It had potential benefits: 31% of patients treated with endovascular thrombectomy achieved functional independence, compared with 14% of patients treated only by a physician.

At present, it is unclear whether thrombectomy is safe and effective in patients with severe ischemic stroke. The treating physicians are faced with a dilemma as to the opportunity to intervene in these patients. Our results represent very good preliminary data that thrombectomy can be safe and effective in this population. It is time to test these results in a randomized trial. "

Amrou Sarraj, MD, first author and corresponding author, badociate professor of neurology, McGovern Medical School of UTHealth

SELECT results have shown reasonable safety results with thrombectomy in patients with greater stroke. The risk of secondary bleeding with thrombectomy has not increased significantly with respect to medical management. The mortality rate decreased with thrombectomy (29%) compared to medical treatment (42%).

The Phase III trial, which will begin in August, will include 560 patients in 30 comprehensive stroke centers in the United States, Canada, and Europe.

"It is proven that the safety and efficacy of the product are proven, SELECT2 will extend thrombectomy indications to improve clinical outcomes in a large group of patients who do not have much treatment options at this stage, "said Sarraj, a member of the UTHealth Institute for the treatment of stroke and cerebrovascular disease. Disease.