NCT03978988Fut, nem toboroz
Thrombectomy In TANdem Occlusion
Intracranial Thrombectomy and Extracranial Carotid Stenting Versus Intracranial Thrombectomy Alone In Acute Anterior Circulation Strokes With TANdem Occlusion : the Randomized Controlled TITAN Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 5.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 432 (tényleges)
- Első benyújtás
- 2019. máj. 29.
- Kezdés
- 2020. ápr. 29.
- Elsődleges befejezés
- 2025. márc. 8.
- Fő szponzor
- Central Hospital, Nancy, France
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT03978988
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 432
- 2020. ápr. 29. és az elsődleges befejezés (2025. márc. 8.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Contraindication to antiplatelet (Aspirin, Plavix), or thrombolytic therapy (Actilyse), or contrast agents, or endovascular products.
Más betegség
- Person under psychiatric care according to articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Életkor
- Woman of childbearing age without effective contraception
Egyéb
- Extracranial internal carotid artery stenosis < 90% (NASCET)
- Rankin score (mRS) > 2
- Patient unable to present or be available for follow-up
- Patient's refusal to participate
- 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
Kiket keres a vizsgálat
- 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)
- 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
- 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.
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| CHRU de Nancy | Vandœuvre-lès-Nancy | Franciaország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.