Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype
NCT ID: NCT05595876
Last Updated: 2024-02-29
Study Results
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Basic Information
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RECRUITING
NA
356 participants
INTERVENTIONAL
2022-12-19
2025-11-01
Brief Summary
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The ASTER Trial showed similar results between stent-retrievers and contact aspiration concerning the recanalization grade in anterior circulation occlusions. However, we still observe late and futile recanalizations, secondary either to extended ischemic lesions at baseline, long-time procedures or intraprocedural complications. The First Pass Effect that is the complete/nearly complete recanalization after the first maneuver, independently on the technique used, has been strongly associated with better clinical outcomes . In a recent paper we proposed a novel approach to identify those cases that could be treated with a specific technique (stent-retriever) with higher chances to achieve a complete or nearly complete recanalization, with lower procedure times and lower complication rates. This approach is focused on the identification of a regular or irregular phenotype of the occlusion site in patients with an M1-Middle Cerebral Artery occlusion. The phenotype is defined as "regular" whether the profile of the occlusion is abruptly cut without any irregularity and as "irregular" if any irregularity of the profile of the occlusion is observed. One of the hypotheses that could explain these results could be related to the composition of the clot : a soft and less organized clot could be more easily flattened by the pulsatile flow and therefore determine a regular aspect of the occlusion. A more solid and organized clot would, on the contrary, maintain an irregular profile because it would not be flattened by the blood flow and the contrast medium could highlight the irregularities of the proximal face of the clot.
The latter could be a favorable target for the use of a stent-retriever since the interaction between a solid clot and the struts of the stent could increase the chance to retrieve the clot. Therefore, we propose this randomized controlled trial to assess the superiority of stent-retrievers compared to contact aspiration in the treatment of irregular phenotype occlusions of the M1-Middle Cerebral Artery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stent retriever
The patients will be treated to receive stent retriever (with or without contact aspiration) first line thrombectomy (experimental arm).
stent retriever thrombectomy
The technique used should be in accordance with the device IFU (instructions for use). A large bore access guide catheter possible is mandatory. A suitable delivery microcatheter is navigated over a microwire across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent is left in place according to the internal practice of each participating center before the withdrawal. Any CE (european compliance)-marked stent retriever device is then deployed across the occlusion. A contact aspiration large bore catheter can be used in association with the stent retriever. A minimum of 3 attempts with Stent retriever should be performed. A revascularization score will be recorded after each device attempt.
Contact aspiration
The patients will be treated to receive direct contact aspiration first line thrombectomy (control arm)
contact aspiration thrombectomy
A 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch microwire inside is then introduced into a large-bore aspiration catheter and this construct is introduced into the long sheath as a unit. A large bore balloon guide catheter has to be placed into the cervical internal carotid artery. The microcatheter is then advanced close to the thrombus and the large-bore aspiration catheter is advanced as close to the proximal aspect of the thrombus as possible. A control angiogram may be used to document the extent of occlusion and thrombus. After a 3 min waiting period, the large-bore aspiration catheter is connected to a continuous aspiration from the dedicated aspiration pump while simultaneously advancing the aspiration catheter up to the face of the thrombus. Once thrombus will be close to the aspiration catheter, then the system will carefully removed as a unit under continuous aspiration.
Interventions
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stent retriever thrombectomy
The technique used should be in accordance with the device IFU (instructions for use). A large bore access guide catheter possible is mandatory. A suitable delivery microcatheter is navigated over a microwire across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent is left in place according to the internal practice of each participating center before the withdrawal. Any CE (european compliance)-marked stent retriever device is then deployed across the occlusion. A contact aspiration large bore catheter can be used in association with the stent retriever. A minimum of 3 attempts with Stent retriever should be performed. A revascularization score will be recorded after each device attempt.
contact aspiration thrombectomy
A 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch microwire inside is then introduced into a large-bore aspiration catheter and this construct is introduced into the long sheath as a unit. A large bore balloon guide catheter has to be placed into the cervical internal carotid artery. The microcatheter is then advanced close to the thrombus and the large-bore aspiration catheter is advanced as close to the proximal aspect of the thrombus as possible. A control angiogram may be used to document the extent of occlusion and thrombus. After a 3 min waiting period, the large-bore aspiration catheter is connected to a continuous aspiration from the dedicated aspiration pump while simultaneously advancing the aspiration catheter up to the face of the thrombus. Once thrombus will be close to the aspiration catheter, then the system will carefully removed as a unit under continuous aspiration.
Eligibility Criteria
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Inclusion Criteria
* M1-Middle Cerebral Artery occlusion
* Eligible for mechanical thrombectomy: groin puncture performed within 24 hours from the first symptoms or from the last time the patient was seen normal.
* Presence of a mismatch on Magnetic resonance imaging MRI or CT (computed tomography) scan
* Baseline mRS \<2
* Irregular occlusion phenotype on the first angiographic run
* Informed consent obtained from the patients/his proxy or following an emergency procedure
* Being covered by a national health insurance
Exclusion Criteria
* Clinical history, past imaging or clinical judgment suggesting underlying intracranial stenosis
* Severe contrast medium allergy or absolute contraindication to use of iodinated products
* Patients with severe or fatal comorbidities that will likely prevent improvement or follow-up, or that will render the procedure unlikely to benefit the patient
* Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment
* Pregnancy (urine or serum beta HCG test for women of child-bearing potential)
* Patient benefiting from a legal protection (guardianship or curatorship)
* Being deprived of liberty
18 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Arturo CONSOLI
Role: PRINCIPAL_INVESTIGATOR
Foch Hospital
Bertrand LAPERGUE
Role: STUDY_CHAIR
Foch Hospital
Locations
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Chu Bordeaux
Bordeaux, , France
CHU Montpellier
Montpellier, , France
Chru Nancy
Nancy, , France
Chu Nantes
Nantes, , France
APHP - Pitié Salpêtrière
Paris, , France
Fondation Adolphe de Rothschild
Paris, , France
CHU de Reims
Reims, , France
Hôpital FOCH
Suresnes, , France
CHU de Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019_0017
Identifier Type: -
Identifier Source: org_study_id
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