Intracranial Thrombosis Clinical Trial
— VECTOROfficial title:
adaptatiVe Endovascular Strategy to the CloT MRI in Large Intracranial Vessel Occlusion
Verified date | December 2022 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In the VECTOR trial, the aim is to analyze, in case of SVS+ occlusions, a first line Embotrap II added to CA combined strategy compare to CA alone strategy. Many practitioners are convinced that a first line strategy with CA alone is easy, safe, rapid and efficient. Maybe, after two, three, four ... passes and with the secondary help of a combined strategy, a high rate of eTICI 2b/3 could be reached with a CA first line strategy. But this could go with a higher number of passes, a waste of time and a suboptimal angiographic results (eTICI 2b) due to distal emboli, especially in case of friable, non-well organized, red blood cell rich (RBC) i.e. SVS + thrombi (25-28). This could, be related to worst clinical outcome at 3 months. VECTOR asks a relevant question: Do the invetigators have to add the use of an Embotrap II or III to the CA, from the first passes, in case of SVS+ clots?
Status | Completed |
Enrollment | 526 |
Est. completion date | October 3, 2022 |
Est. primary completion date | February 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 and older (i.e., candidates must have had their 18th birthday) - Puncture carried out within 24 hours of first symptoms - Suitable 1.5T MRI T2 * Gradient echo that shows a clear susceptibility vessel sign facing the occlusion - Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation, M1 or proximal M2) - Patient or trustworthy person informed about the study and having orally consented to participation in the study. If the patient is unable to receive information and no trustworthy person can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the investigator, in compliance with the French laws - With or without intravenous thrombolysis Exclusion Criteria: - Absence of large vessel occlusion on non-invasive imaging - Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory - Suspected pregnancy; if, in a woman is of child-bearing potential, a urine or serum beta HCG test is positive - Severe contrast medium allergy or absolute contraindication to use of iodinated products - Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic - Patient has severe or fatal comorbidities that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient - Acute ischemic stroke involving posterior circulation (vertebro-basilar occlusion) - Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment - Pregnant or breast-feeding women - Patient benefiting from a legal protection - Non-membership of a national insurance scheme - Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person - Patient with modified Rankin score > 3 before qualifying stroke |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens-Picardie | Amiens | |
France | CH Angers | Angers | |
France | CH Côte Basque | Bayonne | |
France | Hôpital Pellegrin - CHU Bordeaux | Bordeaux | |
France | CHRU Brest | Brest | |
France | Hôpital Bicêtre | Le Kremlin-Bicêtre | |
France | Hôpital Roger Salengro - CHR Lille | Lille | |
France | CHU Limoges | Limoges | |
France | Hospices Civils Lyon | Lyon | |
France | CHU Marseille - Hôpital la Timone | Marseille | |
France | CHU Gui de Chauliac | Montpellier | |
France | CHU Nancy | Nancy | |
France | CHU de Nantes | Nantes | |
France | Fondation Ophtalmologique Adolphe de Rothschild | Paris | |
France | Hôpital Ste Anne | Paris | |
France | La Pitié Salpétrière | Paris | |
France | CH PAU | Pau | |
France | Hôpital Maison Blanche - CHU Reims | Reims | |
France | Hôpital Pontchaillou - CHU Rennes | Rennes | |
France | CHU Strasbourg | Strasbourg | |
France | Hôpital FOCH | Suresnes | |
France | Hôpital Bretonneau - CHU Tours | Tours | |
France | CH Bretagne Atlantique | Vannes |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital | Central Hospital, Nancy, France, University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of near to complete reperfusion after 3 passes of the device defined by a modified treatment in cerebral infarction (eTICI) score of 2c/3 | Preliminary data suggested in case of SVS+ occlusions a superiority of the first line SR strategy in terms of eTICI2c/3 after 3 passes compared to first line CA alone.The first pass (FPE) is an ambitious technical endpoint defined as a successful reperfusion obtained after the first pass that has been recently associated with an increased probability of favorable clinical outcome, a reduced mortality rate and procedural adverse events.However, this constitutes a "very technical" endpoint and the external validity in daily practice would be reduced compared to the three passes cut-off.Even if a FPE eTICI 2b, 2c or 3 has shown better clinical outcome compared to a final eTICI 2b, 2c or 3,there is no study that has proved the better clinical outcome when compared FPE eTICI 2b,2c or 3 to three passes eTICI 2b,2c or 3.Last, there was no preliminary data that suggests in case of SVS+ occlusions, a superiority of the first pass SR strategy in terms eTICI2c/3 compared to first pass CA alone. | At Day 0 immediately after 3 passes | |
Secondary | Near to complete first-pass effect | Defined as a eTICI 2c/3 after first pass device | Day 0 immediately after first pass | |
Secondary | Complete first-pass effect | Defined as a eTICI 3 after first pass device | Day 0 immediately after first pass | |
Secondary | Complete reperfusion | Defined as eTICI 3 after three passes | Day 0 immediately after three passes | |
Secondary | Final near to complete reperfusion | Defined as eTICI 2c/3 final | Day 0 at the end of the intervention | |
Secondary | Final complete reperfusion | Defined as eTICI 3 | Day 0 at the end of the intervention | |
Secondary | Time to achieve eTICI 2c or better revascularization | Time to achieve eTICI 2c or better revascularization | Day 0 | |
Secondary | Time between groin puncture to clot contact | Time between groin puncture to clot contact | Day 0 | |
Secondary | Rate of functional independence | Defined as a modified Rankin scale (mRS) 0-2 | At 90days | |
Secondary | Rate of excellent functional outcome | Defined as a mRS 0-1 | At 90days | |
Secondary | The distribution of mRs scores | Combining scores of 9 and 10 | At 90days | |
Secondary | Change in NIHSS from baseline to 24 hours | Change in NIHSS | Baseline and 24hours | |
Secondary | Rate of symptomatic and asymptomatic intracerebral hemorrhage | Assessment of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan 24h after thrombectomy | At 24hrs | |
Secondary | Rate of parenchymal hematoma type 1 and 2 | Assessment of parenchymal hematoma type 1 and 2 | At 24hrs | |
Secondary | Rate of all-cause mortality at 90 days | Assessment of all-cause mortality at 90 days | At 90days | |
Secondary | Rate of periprocedural complications | Occurrence of emboli to new territory, vasospasm, dissection, perforation and subarachnoid hemorrhage | At 90days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00555932 -
Modern Ultrasound Techniques in the Evaluation of Cerebral Venous Sinuses in Neonates
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N/A |