Thrombectomy In TANdem Occlusion

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.

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.

Sponsors & Collaborators

• Central Hospital, Nancy, France

  lead OTHER

Principal Investigators

• Benjamin GORY, PhD · CHRU de Nancy

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-29

Primary Completion

2025-03-08

Completion

2026-03-06

FDA Device

Yes

Countries

• France

Study Locations