Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype, a Novel Approach in the Endovascular Treatment of Acute Ischemic Stroke: the STRIPE Randomized Trial.

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Patients with a clinico-neuroradiological mismatch pattern shown on the magnetic resonance imaging/Computed Tomography in the acute phase of stroke are more likely to benefit from reperfusion, are suitable candidates for endovascular therapy, and have a better clinical prognosis. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• 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

Locations
Other Locations
France
Chu Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU Montpellier
NOT_YET_RECRUITING
Montpellier
Chru Nancy
RECRUITING
Nancy
Chu Nantes
RECRUITING
Nantes
APHP - Pitié Salpêtrière
RECRUITING
Paris
Fondation Adolphe de Rothschild
RECRUITING
Paris
CHU de Reims
RECRUITING
Reims
Hôpital FOCH
RECRUITING
Suresnes
CHU de Tours
RECRUITING
Tours
Contact Information
Primary
Marthe MAHI
m.mahi@hopital-foch.com
0033146257387
Backup
Arturo CONSOLI
a.consoli@hopital-foch.com
0033146251955
Time Frame
Start Date: 2022-12-19
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 356
Treatments
Experimental: Stent retriever
The patients will be treated to receive stent retriever (with or without contact aspiration) first line thrombectomy (experimental arm).
Sham_comparator: Contact aspiration
The patients will be treated to receive direct contact aspiration first line thrombectomy (control arm)
Related Therapeutic Areas
Sponsors
Leads: Hopital Foch

This content was sourced from clinicaltrials.gov

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