Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
This study has been completed.
Information provided by (Responsible Party):
First received: March 15, 2010
Last updated: October 23, 2012
Last verified: October 2012
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)|
Further study details as provided by Concentric Medical:
Primary Outcome Measures:
- Revascularization status [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure
Secondary Outcome Measures:
- Clinical outcomes at 90 days [ Time Frame: 90-day ] [ Designated as safety issue: No ]Good clinical outcome is defined as an mRS score of 0-2 at 90 days. The change in NIHSS score between baseline and 90 days will also be used to assess clinical outcomes.
- Mortality at 90 days [ Time Frame: 90-day ] [ Designated as safety issue: No ]All cause mortality through 90 days post procedure.
- Device-related serious adverse events (DRSAEs) [ Time Frame: Procedure ] [ Designated as safety issue: Yes ]Vessel perforation or dissection attributable to the Trevo device, or cases where the Trevo device cannot be ruled out as the cause.
- Symptomatic ICH rate within 24 (-6/+12 hours) post-procedure [ Time Frame: Post procedure through 24 hours (-6/+12) ] [ Designated as safety issue: Yes ]SITS-MOST and ECASS III definitions will be used. Symptomatic SAH (subarachnoid hemorrhage) will also be assessed.
|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 patients
Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are candidates for mechanical embolectomy.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088672
|Hospital Clínic de Barcelona|
|Barcelona, Spain, 08036|
Sponsors and Collaborators
|Principal Investigator:||Nils Wahlgren, MD||Karolinska University Hospital in Solna|
|Principal Investigator:||Olav Jansen, MD||Universitätsklinikum Schleswig-Holstein - Campus Kiel UK S-H|