Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
To determine the revascularization rate of the CE-marked Trevo device in large vessel occlusions in ischemic stroke patients.
- Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)|
- Revascularization Status [ Time Frame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment ] [ Designated as safety issue: No ]
Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure
Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.
Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...
Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]
- Clinical Outcomes at 90 Days [ Time Frame: 90-day ] [ Designated as safety issue: No ]
Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days.
mRS 0-2 indicates functional independence 0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
- Mortality at 90 Days [ Time Frame: 90-day ] [ Designated as safety issue: Yes ]All cause mortality through 90 days post procedure.
|Study Start Date:||February 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Acute Ischemic Stroke
Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke
Procedure: Mechanical Thrombectomy
The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Other Name: Trevo Procedure
- Clinical outcomes at 90 days
- Mortality at 90 days
- Device-related serious adverse events (DRSAEs)
- Symptomatic ICH rate within 24 (-6/+12) hours post-procedure
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088672
|Christian Doppler Clinic|
|University Hospital Schleswig-Holstein Campus Kiel|
|Technische Universität München|
|Hospital Clínic de Barcelona|
|Barcelona, Spain, 08036|
|Hospital Universitari Germans Trias i Pujols|
|Karolinska University Hospital|
|Principal Investigator:||Nils Wahlgren, MD||Karolinska University Hospital in Solna|
|Principal Investigator:||Olav Jansen, MD||Universitätsklinikum Schleswig-Holstein - Campus Kiel UK S-H|