Evaluation of Mechanical Thrombectomy in Acute Ischemic Stroke Related to a Distal Arterial Occlusion

NCT ID: NCT05030142

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 488 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-14
• Study Completion Date: 2024-02-14

Brief Summary

Mechanical thrombectomy (MT) has shown its effectiveness for the treatment of acute ischemic stroke (AIS) related to large vessel occlusion and rapidly became a cornerstone in the management of these patients. No strong evidence is available on the benefit of MT in AIS related to more distal occlusions. Some previous observational studies suggested a possible benefit but most of them were single-centre and retrospective studies providing a very low level of evidence. To date, no randomized controlled trial has been conducted in this indication, which represents 10% to 20% of all AIS involving intracranial vessel occlusions.

This research is a multicenter open randomized controlled trial with two parallel groups : best medical treatment alone VS mechanical trombectomy + best medical treatment.

Detailed Description

The main objective of this trial is to assess the efficacy of mechanical thrombectomy in addition to the best medical treatment as compared to the best medical treatment alone in AIS related to a distal intracranial artery occlusion. The medical device used will be a stent retriever among : Trevor NXT ProVue Retriever ; Catchview mini ; pReset Lite ; Tigertriever13, and the medical treatment used will depend on the stroke's etiology and will consist of IV trhombolysis or tenecteplase or antiplatelet therapy or anticoagulant therapy ... The main inclusion criteria are : 1) patients aged ≥ 18 years ; 2) Delay between symptoms onset and expected groin puncture ≤ 6h ; 3) Symptomatic occlusion as evaluated by a National Institute of Health Stroke Score (NIHSS) ≥ 5 ; 4) Distal occlusion evaluated on CT angiography (CTA) or magnetic resonance imaging (MRI) and defined as an occlusion in one of the following segments : a-Distal M2, above the mid-height of the insula, b-M3 segment, c-Posterior cerebral artery (PCA) = P1, P2 or P3 segment, d-Anterior cerebral artery (ACA) : A1, A2 or A3 segment ; 5) Written informed consent signed by the patient or the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will be signed by the patient (if needed by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code).

The secondary objectives and endpoints are to evaluate the : 1) Success of the procedure defined as recanalization of the occluded vessel, evaluated on the AOL (Arterial Occlusion Lesion) score within 48 hours ; 2) Excellent clinical outcome (defined as a modified Rankin scale [mRS]≤1) at 3 months ; 3) Safety with reporting of all adverse and serious adverse events with a particular attention to perforation rate, embolus migration in a new territory and symptomatic hemorrhagic complications ; 4) Death rate up to 3 months ; 5) Cost effectiveness and utility of the procedure. The study will also evaluate the rate of angiographic reperfusion in the intervention group on the final angiogram at the end of the MT (which is part of the intervention) using the modified thrombolysis in cerebral infarction (mTICI) (2B-3) and the eTICI.

Conditions

Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mechanical thrombectomy

Mechanical thrombectomy (using a stent retriever among the following:Trevo NXT ProVue Retriever, Catchview mini, pReset Lite, Tigertriever 13) in association with the best medical treatment (usual care)

Group Type: EXPERIMENTAL

Mechanical Thrombectomy

Intervention Type: PROCEDURE

Mechanical thrombectomy (using a stent retriever among the following:Trevo NXT ProVue Retriever, Catchview mini, pReset Lite, Tigertriever 13) in association with the best medical treatment (usual care)

Active Comparator

Best medical treatment alone (usual care)

Group Type: ACTIVE_COMPARATOR

Best medical treatment alone

Intervention Type: DRUG

Best medical treatment alone (usual care)

Interventions

Mechanical Thrombectomy

Mechanical thrombectomy (using a stent retriever among the following:Trevo NXT ProVue Retriever, Catchview mini, pReset Lite, Tigertriever 13) in association with the best medical treatment (usual care)

Intervention Type: PROCEDURE

Best medical treatment alone

Best medical treatment alone (usual care)

Intervention Type: DRUG

Other Intervention Names

Experimental group; Control group

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥ 18 years
• Delay between symptoms onset and expected groin puncture ≤ 6 h
• Symptomatic occlusion as evaluated by a National Institute of Health Stroke Score (NIHSS) ≥ 5
• Distal occlusion evaluated on CT angiography (CTA) or magnetic resonance imaging (MRI) and defined as an occlusion in one of the following segments:

• Distal M2, above the mid-height of the insula
• M3 segment
• Posterior cerebral artery (PCA): P1, P2, P3 segments
• Anterior cerebral artery (ACA): A1, A2, A3 segments
• Written informed consent signed by the patient or the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will be signed by the patient (if needed by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code)

Exclusion Criteria

• Pregnancy or breastfeeding woman
• Contra-indication for femoral, radial or humeral arterial puncture
• Tandem occlusion (i.e.: concomitant cervical and intra-cranial arterial occlusion)
• Allergy to iodinated contrast media
• Known renal insufficiency (confirmed by previous result of creatinine clearance < 30 ml/min)
• Secondary distal occlusion (i.e., complicating a MT for a proximal occlusion, or any other endovascular intracranial procedure)
• Aortic dissection
• Asymptomatic or minor stroke (i.e.: NIHSS < 5)
• Pretreatment mRS > 1 (pre-stroke)
• Anticipated limitations for anesthesia
• Participation in another trial (Jardé 1 and Jardé 2)
• Absence of affiliation to National French social security system
• Under legal protection measure (tutorship or curatorship) and patient deprived of freedom
• A pre-existing hemorrhage in the brain tissue fed by the target vessel
• Known hypersensitivity to nickel/titanium
• Stenosis and/or with a stent proximal to the site of the thrombus which could preclude the retrieval of the stent retriever
• Angiographic evidence of carotid dissection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Clarençon, Professor

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Frédéric CLARENCON

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Frédéric Clarençon, Professor

Role: CONTACT

frederic.clarencon@aphp.fr

+ 33 1 42 16 35 43

Anne Radenne, Manager

Role: CONTACT

anne.radenne@aphp.fr

+ 33 1 42 16 16 99

Facility Contacts

Anne RADENNE

Role: primary

0142161699

References

Clarencon F, Durand-Zaleski I, Premat K, Baptiste A, Chabert E, Ferrier A, Labeyrie MA, Reiner P, Spelle L, Denier C, Tuilier T, Hosseini H, Rodriguez-Regent C, Turc G, Fauche C, Lamy M, Lapergue B, Consoli A, Barbier C, Boulanger M, Bricout N, Henon H, Gory B, Richard S, Rouchaud A, Macian-Montoro F, Eker O, Cho TH, Soize S, Moulin S, Gentric JC, Timsit S, Darcourt J, Albucher JF, Janot K, Annan M, Pico F, Costalat V, Arquizan C, Marnat G, Sibon I, Pop R, Wolff V, Shotar E, Lenck S, Sourour NA, Radenne A, Alamowitch S, Dechartres A. Evaluation of mechanical thrombectomy in acute ischemic stroke related to a distal arterial occlusion: A randomized controlled trial. Int J Stroke. 2024 Mar;19(3):367-372. doi: 10.1177/17474930231205213. Epub 2023 Oct 12.

Reference Type: DERIVED

PMID: 37740419 (View on PubMed)

Other Identifiers

2021-A00516-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP200028

Identifier Type: -

Identifier Source: org_study_id