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Several studies have demonstrated that simultaneous treatment with two stentrievers (STs) as rescue treatment is very effective, with high recanalization rates even in this group of patients where other revascularization techniques have failed. There has been no observed increase in hemorrhagic complications. Recently, a prospective study has been published where treatment with two ST has been shown to be effective and safe if used as a first-choice treatment (not as rescue) with a successful recanalization rate (eTICI 2c/3) after the first pass of 69%. These results have been reinforced after the publication of a randomized study that confirms, in vitro, the superiority of using two ST over one.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double stentriever technique | Experimental | 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) |
|
| Single stentriever technique | Active Comparator | Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double stentriever | Device | Double stentriever technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass | 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). | 90 days |
| SAFETY OBJECTIVE: Intracerebral hemorrhage. | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention success. | Rate of the ability to position both STs in the indicated location. | During the procedure |
| Complications related to the intervention. | Evaluation of the rate of arterial perforation, angiographic extravasation of contrast, arterial dissection or arterial vasospasm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PEDRO VEGA VALDES, MD, PhD | Contact | 0034985108000 | 39116 | peveval@yahoo.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfried Krupp Hospital Ruettenscheid | Recruiting | Essen | Germany | |||
| Hospital Universitario de Cruces |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35416489 | Background | Vega P, Murias E, Jimenez JM, Chaviano J, Rodriguez J, Calleja S, Delgado M, Benavente L, Castanon M, Puig J, Cigarran H, Arias F, Chapot R. First-line Double Stentriever Thrombectomy for M1/TICA Occlusions : Initial Experiences. Clin Neuroradiol. 2022 Dec;32(4):971-977. doi: 10.1007/s00062-022-01161-2. Epub 2022 Apr 13. | |
| 36627194 |
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Patient & Outcomes adjudicator
| Single stentriever |
| Device |
Single stentriever technique |
|
| During the procedure |
| Embolism in new territories. | Rate of embolization to an artery not involved in the initially affected territory. | During the procedure |
| Number of passes with the devices. | Evaluation of the number of passes with the devices during the procedure. | During the procedure |
| Procedure time. | Time from arterial puncture to arterial recanalization, or if not achieved, until the end of the intervention. | During the procedure |
| Arterial Recanalization (eTICI scale) on first pass. | 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. | During the procedure |
| Arterial recanalization at the end of the procedures. | 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. | During the procedure |
| Intracerebral hemorrhage. | 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). | 24 hours |
| Early neurological improvement. | 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. | 24 hours |
| National Institutes of Health Stroke Scale (NIHSS) scale at 24 hours, on day 5, or at discharge. | 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. | 5 days |
| Modified Rankin Scale (mRS) scale at 90 days. | Modified Rankin Scale (mRS; range 0 [no symptoms] to 6 [death] for the evaluation of neurological functional disability score at 90 days | 90 days |
| Mortality rate. | 90-day mortality rate. | 90 days |
| Recruiting |
| Barakaldo |
| 48903 |
| Spain |
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | 33011 | Spain |
| Hospital ClĂnico Universitario de Valladolid | Recruiting | Valladolid | 47003 | Spain |
| Li J, Tiberi R, Canals P, Vargas D, Castano O, Molina M, Tomasello A, Ribo M. Double stent-retriever as the first-line approach in mechanical thrombectomy: a randomized in vitro evaluation. J Neurointerv Surg. 2023 Dec;15(12):1224-1228. doi: 10.1136/jnis-2022-019887. Epub 2023 Jan 10. |
| 28366064 | Background | Okada H, Matsuda Y, Chung J, Crowley RW, Lopes DK. Utility of a Y-configured stentriever technique as a rescue method of thrombectomy for an intractable rooted thrombus located on the middle cerebral artery bifurcation: technical note. Neurosurg Focus. 2017 Apr;42(4):E17. doi: 10.3171/2017.1.FOCUS16511. |
| 34233944 | Background | Cabral LS, Mont'Alverne F, Silva HC, Passos Filho PE, Magalhaes PSC, Bianchin MM, Nogueira RG. Device size selection can enhance Y-stentrieving efficacy and safety as a rescue strategy in stroke thrombectomy. J Neurointerv Surg. 2022 Jun;14(6):558-563. doi: 10.1136/neurintsurg-2021-017751. Epub 2021 Jul 7. |
| 32973671 | Background | Li Z, Liu P, Zhang L, Zhang Y, Fang Y, Xing P, Huang Q, Yang P, Liu J. Y-Stent Rescue Technique for Failed Thrombectomy in Patients With Large Vessel Occlusion: A Case Series and Pooled Analysis. Front Neurol. 2020 Aug 27;11:924. doi: 10.3389/fneur.2020.00924. eCollection 2020. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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