Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype

NCT05595876 | Recruiting

• 1 other identifier: 2019_0017
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Rate of favorable functional outcome at 90-day defined by a Modified Rankin Scale (mRS) 0-2

  mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death

  3 months

Secondary Outcomes (10)

• Rate of patients with first pass effect (FPE) defined as mTICI 2c/3 after first device maneuver

  24 hours

• Rates of patients with complete (mTICI 3), perfect (mTICI 2c/3) and successful reperfusion (mTICI 2b/3) at the end of endovascular procedure

  24 hours

• Time from groin puncture to achieve the maximum recanalization

  24 hours

• Rate of patients who will require less than 2 device pass

  24 hours

• Rate of patients with rescue therapy use

  24 hours

Study Arms (2)

Stent retriever

EXPERIMENTAL

The patients will be treated to receive stent retriever (with or without contact aspiration) first line thrombectomy (experimental arm).

Procedure: stent retriever thrombectomy

Contact aspiration

SHAM COMPARATOR

The patients will be treated to receive direct contact aspiration first line thrombectomy (control arm)

Procedure: contact aspiration thrombectomy

Interventions

stent retriever thrombectomy PROCEDURE

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.

Stent retriever

contact aspiration thrombectomy PROCEDURE

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.

Contact aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Isolated M2 occlusions
• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (9)

Chu Bordeaux

Bordeaux, France

NOT YET RECRUITING

CHU Montpellier

Montpellier, France

NOT YET RECRUITING

Chru Nancy

Nancy, France

RECRUITING

Chu Nantes

Nantes, France

RECRUITING

APHP - Pitié Salpêtrière

Paris, France

RECRUITING

Fondation Adolphe de Rothschild

Paris, France

RECRUITING

CHU de Reims

Reims, France

RECRUITING

Hôpital FOCH

Suresnes, France

RECRUITING

CHU de Tours

Tours, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arturo CONSOLI

  Foch Hospital

  PRINCIPAL INVESTIGATOR

• Bertrand LAPERGUE

  Foch Hospital

  STUDY CHAIR

Central Study Contacts

Marthe MAHI

CONTACT

0033146257387; m.mahi@hopital-foch.com

Arturo CONSOLI

CONTACT

0033146251955; a.consoli@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The angiographic outcomes will be assessed by a centralized Core Laboratory, not involved in patient management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: December 19, 2022
• Primary Completion: February 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)