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ACTIVE NOT RECRUITING

NCT03978988

Thrombectomy In TANdem Occlusion

Sponsor: Central Hospital, Nancy, France

View on ClinicalTrials.gov

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.

Official title: Intracranial Thrombectomy and Extracranial Carotid Stenting Versus Intracranial Thrombectomy Alone In Acute Anterior Circulation Strokes With TANdem Occlusion : the Randomized Controlled TITAN Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

432

Start Date

2020-04-29

Completion Date

2026-03-06

Last Updated

2025-06-05

Healthy Volunteers

Conditions

Carotid Artery Diseases Thrombectomy Tandem Occlusion Stroke

Interventions

DEVICE

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.

DRUG

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.

DRUG

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)

PROCEDURE

Intracranial thrombectomy

Intracranial thrombectomy is the endovascular procedure. In the experimental group, thrombectomy will be completed with a extracranial carotid stenting.

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.

Locations (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, France