Thrombectomy In TANdem Occlusion

NCT03978988 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2019-A01085-52
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

stroke; tandem occlusion; carotid stenting; thrombectomy

Outcome Measures

Primary Outcomes (1)

• Change in Modified treatment in cerebral ischemia (mTICI) score AND National Institutes of Health Stroke Scale (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.

  at the end of angiography(mTICI score) , at 24 hours (NIHSS score)

Secondary Outcomes (20)

• Efficacy outcomes : Rate of reperfusion with change in Modified treatment in cerebral ischemia (mTICI) score

  at the end of the endovascular procedure

• Efficacy outcomes : Change in National Institutes of Health Stroke Scale (NIHSS) score

  at 24 hours (±6) hours

• Efficacy outcomes : number of participants with delays of symptoms

  at the end of the endovascular procedure

• Efficacy outcomes : Number of passes

  at the end of the endovascular procedure

• Efficacy outcomes : Infarct growth (volume)

  At 24hours (±6) hours

Study Arms (2)

Thrombectomy + Carotid Stenting

EXPERIMENTAL

Intravenous thrombolysis will be administered if possible. Standard mechanical thrombectomy(MT) will be performed with a balloon Guide Catheter. MT technique will be left at the discretion of the operators. Concerning the cervical disease, 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. An intravenous bolus of 250mg of Aspirin (up to Imaging 24H) will be given at the end of the procedure in case of absence of complication. Intravenous sedation or general anesthesia will be permitted.A second antiplatelet agent is used if a thrombus is formed : IV or nasogastric tube (choice by operator) A dual antiplatelet therapy is administered after 24H imaging follow-up excluding intracranial hemorrhagic complications (discretion of the local practice)

Device: Carotid Stenting; Drug: Procedural Aspirin; Drug: Dual dual antiplatelet therapy after 24-hours imaging follow-up; Procedure: Intracranial thrombectomy

Thrombectomy alone

NO INTERVENTION

Endovascular procedure: Intracranial thrombectomy alone (carotid angioplasty may be performed)

Interventions

Carotid Stenting DEVICE

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.

Thrombectomy + Carotid Stenting

Procedural Aspirin DRUG

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.

Thrombectomy + Carotid Stenting

Dual dual antiplatelet therapy after 24-hours imaging follow-up DRUG

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)

Thrombectomy + Carotid Stenting

Intracranial thrombectomy PROCEDURE

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

Thrombectomy + Carotid Stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged ≥ 18 years
• 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).
• NIHSS Score ≥ 6
• Arterial puncture performed :
• \> Within 8 hours (after the first symptoms or last seen well) with ASPECTS Score ≥5 by CT or MRI (DWI)
• \> 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
• Person affiliated to or beneficiary of a social security plan
• Person undergone the medical examination adapted to research Subjects treated with prior intravenous thrombolysis are eligible for participation

You may not qualify if:

• Extracranial internal carotid artery stenosis \< 90% (NASCET)
• Rankin score (mRS) \> 2
• Contraindication to antiplatelet (Aspirin, Plavix), or thrombolytic therapy (Actilyse), or contrast agents, or endovascular products.
• Patient unable to present or be available for follow-up
• Patient's refusal to participate
• Woman of childbearing age without effective contraception
• Pregnant, parturient or breastfeeding woman
• Minor person (non emancipated)
• Adult person under legal protection (any form of public guardianship)
• Person deprived of liberty for judicial or administrative decision
• Person under psychiatric care according to articles L. 3212-1 and L. 3213-1 of the Public Health Code.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• Zhu F, Hossu G, Soudant M, Richard S, Achit H, Beguinet M, Costalat V, Arquizan C, Consoli A, Lapergue B, Rouchaud A, Macian-Montoro F, Biondi A, Moulin T, Marnat G, Sibon I, Paya C, Vannier S, Cognard C, Viguier A, Mazighi M, Obadia M, Hassen WB, Turc G, Clarencon F, Samson Y, Dumas-Duport B, Preterre C, Barbier C, Boulanger M, Janot K, Annan M, Bricout N, Henon H, Soize S, Moulin S, Labeyrie MA, Reiner P, Pop R, Wolff V, Ognard J, Timsit S, Reyre A, Perot C, Papagiannaki C, Triquenot-Bagan A, Bracard S, Anxionnat R, Derelle AL, Tonnelet R, Liao L, Schmitt E, Planel S, Guillemin F, Gory B. Effect of emergent carotid stenting during endovascular therapy for acute anterior circulation stroke patients with tandem occlusion: A multicenter, randomized, clinical trial (TITAN) protocol. Int J Stroke. 2021 Apr;16(3):342-348. doi: 10.1177/1747493020929948. Epub 2020 Jun 9.

  PMID: 32515696 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Benjamin GORY, PhD

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 7, 2019
• Study Start: April 29, 2020
• Primary Completion: March 8, 2025
• Study Completion: March 6, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

FR (1)