Carotid Stenting: emergent carotid stenting will be performed if the patient is randomized in the intervention arm. The order to treat (head first or neck first), and the choice of a previous angioplasty of the extracranial carotid artery lesion will be left to the interventionist discretion.
Procedural Aspirin: After carotid stenting, an intravenous bolus of 250mg of Aspirin will be given at the end of the procedure in case of absence of complication.
Dual dual antiplatelet therapy after 24-hours imaging follow-up: A dual antiplatelet therapy is administered after 24-hours imaging follow-up excluding intracranial hemorrhagic complications (the type and the dose of the dual antiplatelet therapy are left to the discretion of the local practice)
Intracranial thrombectomy: Intracranial thrombectomy is the endovascular procedure. In the experimental group, thrombectomy will be completed with a extracranial carotid stenting.
Study summary
Tandem occlusion is defined by an acute ischemic stroke (AIS) with concomitant steno-occlusive disease of the extra cranial carotid artery and concerned about 10% of AIS patients. Whereas endovascular treatment has shown its efficiency in AIS by large vessel occlusion (LVO), to date, there is no consensus on the endovascular management of the extra cranial carotid artery in tandem occlusion. Only few of them were included in previous randomized trials who evaluated mechanical thrombectomy and were often listed in the non-inclusion criteria. Therapeutic management of this population was not specifically addressed in recent trials. Endovascular management can be complex with the need of acute stenting of the extra cranial carotid lesion along with the potential need of antithrombotic therapy initiation, the benefit and the safety of stenting of the cervical lesion in acute phase of AIS have shown encouraging results but however remains to be assessed. The TITAN (Thrombectomy In TANdem lesion) trial aims to demonstrate the superiority of the combined use of intracranial thrombectomy and extracranial carotid stenting compared to intracranial thrombectomy alone on the complete reperfusion rate in patients with acute ischemic stroke due to tandem lesion.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subject aged ≥ 18 years
2. Tandem occlusion confirmed by MR angiography or CT-angiography or digital subtraction angiography of supra-aortic vessels, in connection with atheromatous plaque or dissection, defined with:
* Proximal intracranial occlusion (ICA, M1 and/or M2) eligible for thrombectomy
* Extracranial lesion of the internal carotid artery (stenosis ≥90% NASCET or complete occlusion).
3. NIHSS Score ≥ 6
4. Arterial puncture performed :
-\> Within 8 hours (after the first symptoms or last seen well) with ASPECTS Score ≥5 by CT or MRI (DWI)
OR
-\> Between 8 and 24 hours :
* If perfusion imaging performed: according to the DEFUSE3 trial criteria (ischemia ≤70 mL, ischemia-hypoperfusion ratio≥1.8, and hypoperfusion volume ≥15 mL)
* If perfusion imaging not performed: according to the DAWN trial criteria :
* Age ≥80 years with NIHSS ≥10 and ischemia ≤21 mL
* Age \<80 years with NIHSS ≥10 and ischemia ≤31 mL
* Age \<80 years with NIHSS ≥20 and ischemia ≤51 mL
5. The patient or his or her representative has received information about the study organization and has signed and dated the informed consent form/ inclusion in emergency situation in accordance with Article L1122-1-3 of the Public Health Code.
6. Person affiliated to or beneficiary of a social security plan
7. Person undergone the medical examination adapted to research Subjects treated with prior intravenous thrombolysis are eligible for participation
Exclusion Criteria:
1. Extracranial internal carotid artery stenosis \< 90% (NASCET)
2. Rankin score (mRS) \> 2
3. Contraindication to antiplatelet (Aspirin, Plavix), or thrombolytic therapy (Actilyse), or contrast agents, or endovascular products.
4. Patient unable to present or be available for follow-up
5. Patient's refusal to participate
6. Woman of childbearing age without effective contraception
7. Pregnant, parturient or breastfeeding woman
8. Minor person (non emancipated)
9. Adult person under legal protection (any form of public guardianship)
10. Person deprived of liberty for judicial or administrative decision
11. Person under psychiatric care according to articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Primary outcome measure(s)
Change in Modified treatment in cerebral ischemia (mTICI) score AND National Institutes of Health Stroke Scale (NIHSS) score — at the end of angiography(mTICI score) , at 24 hours (NIHSS score) Complete reperfusion rate at the end of angiography defined as a modified Thrombolysis in Cerebral Infarction (mTICI) 3 score and defined as an Improvement of the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 mTICI score : 0:no perfusion ; 1:penetration with minimal perfusion ; 2:partial perfusion
; 2a:partial filling of less than 1/2 of the vascular territory ; 2b:partial filling 50-99% of the vascular territory ; 3:complete perfusion .
NIHSS : 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.
Trial sites (1)
Facility
City
Region
Status
CHRU de Nancy
Vandœuvre-lès-Nancy
France
More Central Hospital, Nancy, France trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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