Informations générales (source: ClinicalTrials.gov)
Evaluation of Mechanical Thrombectomy in Acute Ischemic Stroke Related to a Distal Arterial Occlusion: a Randomized Controlled Trial (DISCOUNT)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2021
février 2024
26 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | CLARENCON Frederic | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | CLARENCON Frederic | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | CLARENCON Frederic | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | CLARENCON Frederic | 18/04/2025 07:55:26 | Contacter | ||
| HOPITAL FOCH | ARTURO CONSOLI | 05/05/2025 07:12:10 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | William BOISSEAU | 19/12/2024 14:06:32 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Frédéric CLARENCON - 75013 - Paris - France | Anne RADENNE | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
- 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)
- 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