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

NCT05030142 | Unknown DMC

• 2 other identifiers: APHP2000282021-A00516-35
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

Keywords

Acute Ischemic Stroke; Distal occlusions; Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Good clinical outcome (defined as a modified Rankin Scale [mRS] ≤ 2)

  mRS of 0-2 (evaluated by an independent assessor blinded to the intervention received by the patient)

  At 3 months

Secondary Outcomes (12)

• Recanalization of the occluded vessel

  48 hours after the mechanical thrombectomy

• Angiographic reperfusion in the intervention group

  End of the mechanical thrombectomy procedure

• Excellent Clinical outcome (defined as a modified Rankin Scale [mRS] ≤ 1)

  At 3 months

• Perforation rate

  End of mechanical thrombectomy procedure

• Embolus migration in a new territory

  End of mechanical thrombectomy procedure

Study Arms (2)

Mechanical thrombectomy

EXPERIMENTAL

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)

Procedure: Mechanical Thrombectomy

Active Comparator

ACTIVE COMPARATOR

Best medical treatment alone (usual care)

Drug: Best medical treatment alone

Interventions

Mechanical Thrombectomy 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)

Also known as: Experimental group

Mechanical thrombectomy

Best medical treatment alone DRUG

Best medical treatment alone (usual care)

Also known as: Control group

Active Comparator

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Frédéric CLARENCON

Paris, 75013, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 37740419 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Frédéric Clarençon, Professor

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Clarençon, Professor

CONTACT

+ 33 1 42 16 35 43; frederic.clarencon@aphp.fr

Anne Radenne, Manager

CONTACT

+ 33 1 42 16 16 99; anne.radenne@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: September 1, 2021
• Study Start: November 14, 2021
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)