Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583889
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Endovascular Treatment or Standard Medical Care for Cerebral Venous Sinus ThrombosisESCORT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of endovasCular Treatment vs Standard Medical Care for Cerebral venOus Sinus thRombosis With mulTimodal Imaging SelectionESCORT
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCORT
Brief Summary:
Background It has not been extensively studied in differing populations that endovascular treatment EVT for acute and subacute CVST with multimodal imaging selection improves the functional outcome better than standard medical care based on the guidelines Published experience with endovascular treatment is promising However its efficacy has not been confirmed and early selection criteria for EVT are unknown
ObjectiveThe main objective of the Endovascular treatment or Standard medical Care for Cerebral Venous Sinus Thrombosis ESCORT trial is to determine if EVT improves the functional outcome of acute and subacute CVST patients with multimodal imaging selection
Study DesignThe ESCORT trial is a multicenter prospective randomized open-label blinded endpoint trial
Study population Patients are eligible if they have a radiologically criteria proven acute and subacute CVST obvious symptoms of intracranial hypertensionlumbar puncture pressure250mmH2O
Intervention Patients will be randomized to receive either EVT or standard medical care therapeutic doses of heparin EVT consists of local application of alteplase or urokinase within the thrombosed sinuses balloon angioplasty andor mechanical thrombectomy Glasgow coma score NIH stroke scale ophthalmologic examination Headache Impact Test-6HIT-6 EuroQol-5 dimension-5 levelEQ-5D-5L scale score multimodal imaging and relevant laboratory parameters will be assessed at baseline
Endpoints The primary endpoint is the proportion with good prognosis at 3 months definition a mRS1 b headache score 50 HIT-6 c Frisén0 grade for papilledema d defect of field vision PMD-2dB Secondary outcomes are three-months mRS HIT-6Frisén grade for papilledema situation of EQ-5D-5L mortality and recanalization rate Major intracranial and extracranial hemorrhagic complications within one-week after the intervention are the principal safety outcomes Results will be analyzed according to theintention-to-treat principle Blinded assessors not involved in the treatment of the patient will assess endpoints with standardized questionnaires
Study size To detect a 20 relative increase of good prognosis from 65 to 85 224 patients 112 in each treatment arm have to be included two-sided alpha 80 power
Nature and extent of the burden and risks associated with participation benefit and group relatedness Included patients may benefit directly from EVT Complications of EVT most notably intracranial hemorrhages constitute the most important risk of the study
ObjectiveThe main objective of the Endovascular treatment or Standard medical Care for Cerebral Venous Sinus Thrombosis ESCORT trial is to determine if EVT improves the functional outcome of acute and subacute CVST patients with multimodal imaging selection
Study DesignThe ESCORT trial is a multicenter prospective randomized open-label blinded endpoint trial
Study population Patients are eligible if they have a radiologically criteria proven acute and subacute CVST obvious symptoms of intracranial hypertensionlumbar puncture pressure250mmH2O
Intervention Patients will be randomized to receive either EVT or standard medical care therapeutic doses of heparin EVT consists of local application of alteplase or urokinase within the thrombosed sinuses balloon angioplasty andor mechanical thrombectomy Glasgow coma score NIH stroke scale ophthalmologic examination Headache Impact Test-6HIT-6 EuroQol-5 dimension-5 levelEQ-5D-5L scale score multimodal imaging and relevant laboratory parameters will be assessed at baseline
Endpoints The primary endpoint is the proportion with good prognosis at 3 months definition a mRS1 b headache score 50 HIT-6 c Frisén0 grade for papilledema d defect of field vision PMD-2dB Secondary outcomes are three-months mRS HIT-6Frisén grade for papilledema situation of EQ-5D-5L mortality and recanalization rate Major intracranial and extracranial hemorrhagic complications within one-week after the intervention are the principal safety outcomes Results will be analyzed according to theintention-to-treat principle Blinded assessors not involved in the treatment of the patient will assess endpoints with standardized questionnaires
Study size To detect a 20 relative increase of good prognosis from 65 to 85 224 patients 112 in each treatment arm have to be included two-sided alpha 80 power
Nature and extent of the burden and risks associated with participation benefit and group relatedness Included patients may benefit directly from EVT Complications of EVT most notably intracranial hemorrhages constitute the most important risk of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None