Clinical trial NCT01088672: Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
Official title: Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: Stroke
Ischemic
Thrombus
Embolectomy
Thrombectomy
Concentric
Embolus
Mechanical
Trevo
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2010-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: * 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

Eligibility criteria: Inclusion Criteria:

* Age 18-79 (has had 18th birthday, but not yet had 80th birthday)
* NIHSS 8 - 30
* Anticipated life expectancy of at least 6 months
* No significant pre-stroke disability (mRS less than or equal to 1)
* Written informed consent to participate given by patient or legal representative
* Angiographic confirmation of a persistent large vessel occlusion, in the internal carotid, middle cerebral M1 and/or M2 segments, basilar or vertebral arteries
* Treatable within 8 hours of symptom onset, defined as the first pass being made with the Trevo device.

Exclusion Criteria:

* Baseline glucose of \< 50 mg/dL (2.78 mmol) or \> 400 mg / dL (22.20 mmol)
* Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
* Treated with Heparin within 48 hours with a PTT greater than 2 times the lab normal
* Baseline platelet count \< 30,000
* History of severe allergy (more than rash) to contrast medium
* Severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using medication (i.e. Nipride), the patient can be enrolled
* Woman of child bearing potential who is known to be pregnant
* Patient participating in another clinical study or protocol
* For anterior circulation strokes: strokes involving greater than 1/3 of the MCA territory, as determined by hypodensity on the baseline non- contrast CT, or low CBV on CT Perfusion imaging, or restricted diffusion on DWI images
* For posterior circulation strokes within the midbrain and/or pons, extensive hypodensity on the baseline CT, or low CBV on CT Perfusion imaging, or extensive restricted diffusion on DWI images
* Baseline CT/MR evidence of significant mass effect with midline shift
* Baseline CT/MR evidence of hemorrhage
* Baseline CT/MR evidence of intracranial tumor (except small meningioma)
* Angiographic evidence of vasculitis or arterial dissection
* High grade stenosis that cannot be treated safely or which prevents access to the thrombus with the Trevo device
* Angiographic evidence of excessive arterial tortuosity that precludes the Trevo device from reaching the thrombus

Primary outcomes:
measure: Revascularization Status
timeFrame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
Secondary outcomes:
measure: Clinical Outcomes at 90 Days
timeFrame: 90-day
measure: Mortality at 90 Days
timeFrame: 90-day
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Christian Doppler Clinic
city: Gottingen
country: Germany
facility: Universitätsklinik Göttingen
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein Campus Kiel
city: Munich
country: Germany
facility: Technische Universität München
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujols
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital in Solna
name: Nils Wahlgren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Schleswig-Holstein - Campus Kiel UK S-H
name: Olav Jansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansen O, Macho JM, Killer-Oberpfalzer M, Liebeskind D, Wahlgren N; TREVO Study Group. Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study. Cerebrovasc Dis. 2013;36(3):218-25. doi: 10.1159/000353990. Epub 2013 Oct 12.
citation: Shi ZS, Liebeskind DS, Xiang B, Ge SG, Feng L, Albers GW, Budzik R, Devlin T, Gupta R, Jansen O, Jovin TG, Killer-Oberpfalzer M, Lutsep HL, Macho J, Nogueira RG, Rymer M, Smith WS, Wahlgren N, Duckwiler GR; Multi MERCI, TREVO, and TREVO 2 Investigators. Predictors of functional dependence despite successful revascularization in large-vessel occlusion strokes. Stroke. 2014 Jul;45(7):1977-84. doi: 10.1161/STROKEAHA.114.005603. Epub 2014 May 29.