NCT06071091Active, not recruiting
Permanent Intracranial Stenting for Acute Ischemic Stroke Related to a Refractory Large Vessel Occlusion
Comparison of Permanent Intracranial Stenting Versus no Stenting in Stroke Secondary to Refractory Acute Proximal Vascular Occlusion: a Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 9 Jan 2024
Brief summary (registry, in English)
Clot extraction failure during mechanical thrombectomy is a major concern in the management of acute ischemic stroke related to large vessel occlusions. Indeed, it can occur in up to 10 to 30% of cases and, therefore, is associated with a very poor prognosis. These refractory occlusions frequently occur when an underlying intracranial atherosclerotic disease is present. Thus, one of the most promising rescue technique consists of placing a permanent intracranial stent, under dual antiplatelet therapy over the target refractory occlusion. This strategy is well studied in coronary occlusions where the atheroscotic mechanism is highly prevalent. However, as the ischemiated brain is at much higher risk of hemorrhagic complications, such strategy entails a greater risk. This raises the question of whether such risk is worth the reward of obtaining reperfusion. The investigators designed this randomized study in order to evaluate whether a strategy combining rescue pemanent intracranial stenting with the best medical treatment is superior to the best medical treatment alone in acute refractory large vessel occlusions.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 346 (estimated)
- First submitted
- 4 Sept 2023
- Start date
- 8 Nov 2023
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Stroke
- NCT number
- NCT06071091
What you commit to
- Study type: Interventional
- Planned participants: 346
- From 8 Nov 2023 to the primary completion date, 1 Feb 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intracranial bleeding \<3 months or intracranial bleeding during TM procedure prior to inclusion
- Contraindication to a dual antiplatelet therapy
Other illness
- Proven allergy to iodinated contrast material
Lab values
- Patient known for severe renal impairment with creatinine clearance \< 30ml/min
Other
- Proximal intracranial vascular occlusion not confirmed on angiography
- Mechanical thrombectomy procedure requiring carotid or vertebral arterial access by direct puncture
- Proof of significant ischemic lesions in a vascular territory not affected by the occlusion
- Pregnant or breastfeeding women
- Tandem occlusion (defined as the association of an intracranial occlusion to a cervical steno-occlusive lesion on the same arterial axis that needs additional endovascular manœuvers for the cervical lesion)
- Major comorbidities that could hinder the improvement or the follow up of the patient or the benefit of the intervention
- Unaffiliation to the French Social Security system
- Patient under juridic protection
- Patient participating in another interventional trial
Who the study is looking for
- Age\>18 years
- Acute ischemic stroke secondary to an occlusion of the internal carotid artery termination OR the 1st or 2nd segment of the middle cerebral artery OR the basilar artery and/or the 4th segment of the vertebral artery radiologically proven (CT Angiography or angio-MRI)
- Patient within the authorised timeframe for a MT, according to the AHA/ASA 2019 grade I recommendations
- Refractory intracranial large vessel occlusion defined as :
- Persistent arterial occlusion (mTICI 0 or I) after a minimum of 3 mechanical thrombectomy passes using direct aspiration or a stent retriever OR Early arterial reocclusion (\<10 minutes) after at least one pass OR Underlying stenosis (estimated between 70 and 99%)
- ASPECT Score for CT or DWI-ASPECTS for MRI or pc(-DWI)- ASPECTS (posterior circulation) ≥ 5
- Independent patient before stroke (mRS 0-2)
- Patient's or her/his trusted relative's consent or emergency procedure consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU Bordeaux (Pellegrin Hospital) Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Henri-Mondor Hospital (APHP) Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Bicêtre Hospital (APHP) Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Bicêtre Hospital (AP-HP) Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| CHU Lille (Roger Salengro Hospital) Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU Montpellier - Gui de Chauliac Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHRU de Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Lariboisière Hospital (APHP) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| APHP • Assistance Publique des Hôpitaux de Paris, Pitié-Salpêtrière hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Foch Hospital Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.