Thrombectomy In TANdem Occlusion

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France
• Treatments: Aspirin

Criteria

Inclusion Criteria:

1. Subject aged ≥ 18 years

2. Tandem occlusion at angiography, 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. ASPECTS Score ≥ 6 by scanner or MRI (DWI)

5. Arterial puncture within 8 hours (after the first symptoms or last seen well)

6. 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.

7. Person affiliated to or beneficiary of a social security plan

8. 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) on the first angiographic run

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.