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

• Status: Not yet recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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