Results of the Use of Two Stentrievers Simultaneosly Compared With One as a Primary Treatment in Acute Ischemic Stroke
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|ClinicalTrials.gov Identifier: NCT05930145|
Recruitment Status : Not yet recruiting
First Posted : July 5, 2023
Last Update Posted : July 27, 2023
|Condition or disease||Intervention/treatment||Phase|
|Stroke Thrombectomy Arterial Occlusive Diseases||Device: Double stentriever Device: Single stentriever||Not Applicable|
The use of a double stent retriever has been proposed as a safe and effective technique. The investigators hypothesized that the use of double stentriever primary could lead to higher first pass effect rates and better outcomes compared to single stentriever primary.
Our goal is to develop a research project to provide additional information on the potential benefits of the simultaneous double stent approach primarily in stroke patients receiving endovascular treatment.
A randomized study to compare the efficacy of double primary stentriever versus single primary stentriever.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Patient & Outcomes adjudicator|
|Official Title:||A Randomized Study Comparing the Effectiveness and Security of the Use of Two Stentrievers Simultaneously Versus One Stentriever as a Primary Treatment in Acute Ischemic Stroke Patients.|
|Estimated Study Start Date :||September 1, 2023|
|Estimated Primary Completion Date :||September 1, 2024|
|Estimated Study Completion Date :||September 1, 2024|
Experimental: Double stentriever technique
Patients treated with thrombectomy with a proximal balloon guiding catheter using two stentrievers simultaneously (one of 6 mm x 50 mm and another of 6 mm x 50 mm or 4 mm x 35 mm)
Device: Double stentriever
Double stentriever technique
Active Comparator: Single stentriever technique
Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm).
Device: Single stentriever
Single stentriever technique
- EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass [ Time Frame: 90 days ]Comparison of the complete recanalization rate in the first pass in the double stent group compared to the single stent group, defined as TICI greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale).
- SAFETY OBJECTIVE: Intracerebral hemorrhage. [ Time Frame: 24 hours ]Rate of patients with symptomatic intracranial hemorrhage (neurological deterioration in National Institutes of Health Stroke Scale [NIHSS] >4) at 24h observed between both groups and, fundamentally, evaluated by CT.
- Intervention success. [ Time Frame: During the procedure ]Rate of the ability to position both STs in the indicated location.
- Complications related to the intervention. [ Time Frame: During the procedure ]Evaluation of the rate of arterial perforation, angiographic extravasation of contrast, arterial dissection or arterial vasospasm.
- Embolism in new territories. [ Time Frame: During the procedure ]Rate of embolization to an artery not involved in the initially affected territory.
- Number of passes with the devices. [ Time Frame: During the procedure ]Evaluation of the number of passes with the devices during the procedure.
- Procedure time. [ Time Frame: During the procedure ]Time from arterial puncture to arterial recanalization, or if not achieved, until the end of the intervention.
- Arterial Recanalization (eTICI scale) on first pass. [ Time Frame: During the procedure ]evaluation of the rates of eTICI 3, eTICI 2c/3, eTICI e2b/3 on the Thrombolysis in Cerebral Infarction scale (e TICI scale); range 0-3, with highest score indicating complete recanalization.
- Arterial recanalization at the end of the procedures. [ Time Frame: During the procedure ]eTICI 3, eTICI e2c/3, eTICI e2b/3 at the end of the procedure on the Thrombolysis in Cerebral Infarction scale (e TICI scale); range 0-3, with highest score indicating complete recanalization.
- Intracerebral hemorrhage. [ Time Frame: 24 hours ]Rate of any type of intracranial hemorrhage on the 24-hour control computed tomography (CT) scan (subarachnoid hemorrhage and hemorrhage according to the classification used in the ECASS study).
- Early neurological improvement. [ Time Frame: 24 hours ]Rate of patients with a decrease of 10 points or more on the NIHSS scale or complete recovery during the first 24 hours. Improvement of Neurological status at 24 hours, determined by National Institutes of Health Stroke Scale [NIHSS score] range 0-42, with higher scores indicating greater stroke severity.
- National Institutes of Health Stroke Scale (NIHSS) scale at 24 hours, on day 5, or at discharge. [ Time Frame: 5 days ]Neurological status at 24 hours, at day 5 (+/- 12 hours) or discharge, determined by National Institutes of Health Stroke Scale [NIHSS score] range 0-42, with higher scores indicating greater stroke severity.
- Modified Rankin Scale (mRS) scale at 90 days. [ Time Frame: 90 days ]Modified Rankin Scale (mRS; range 0 [no symptoms] to 6 [death] for the evaluation of neurological functional disability score at 90 days
- Mortality rate. [ Time Frame: 90 days ]90-day mortality rate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05930145
|Contact: PEDRO VEGA VALDES, MD, PhD||0034985108000 ext email@example.com|