Endovascular treatment for carotid artery lesions in stroke patients
Intracranial Thrombectomy and Extracranial Carotid Stenting Versus Intracranial Thrombectomy Alone In Acute Anterior Circulation Strokes With TANdem Occlusion : the Randomized Controlled TITAN Trial
This study is testing if certain procedures for treating blocked carotid arteries can help stroke patients recover better and improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 432 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Vandoeuvre les Nancy) |
| Trial ID | NCT03978988 on ClinicalTrials.gov |
What this trial studies
The TITAN trial is a prospective, randomized, multi-center clinical trial aimed at determining the optimal endovascular management of extra cranial carotid artery lesions in patients with tandem occlusion and large vessel occlusion (LVO) during an acute ischemic stroke. Patients will be recruited from 13 comprehensive stroke centers in France and will undergo procedures including carotid stenting and thrombectomy. The study will assess the safety and efficacy of these interventions in improving outcomes for patients with significant neurological deficits. Informed consent will be obtained from eligible patients or their relatives under emergency protocols.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed tandem occlusion and significant neurological deficits who are eligible for thrombectomy.
Not a fit: Patients with mild neurological deficits or those who do not meet the specific inclusion criteria for tandem occlusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could improve treatment strategies for patients suffering from acute ischemic strokes with tandem occlusions, potentially leading to better recovery outcomes.
How similar studies have performed: While there have been few studies addressing this specific condition, the approach of combining carotid stenting with thrombectomy has shown promising results in related contexts, though this specific methodology remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vandoeuvre les Nancy
- CHRU de Nancy — Vandoeuvre les Nancy, France (Recruiting)
Study contacts
- Principal investigator: Benjamin GORY, PhD — CHRU de Nancy
- Study coordinator: Benjamin GORY, PhD
- Email: b.gory@chru-nancy.fr
- Phone: +33383851501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.