Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)

Ischemic Stroke Clinical Trial

— TREVO  

Official title:

Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088672
• Other study ID #: DQR0036
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2010
• Last updated: July 13, 2015
• Start date: February 2010
• Est. completion date: November 2011

Study information

• Verified date: July 2015
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Mechanical Thrombectomy
The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

Locations

Country	Name	City	State
Austria	Christian Doppler Clinic	Salzburg
Germany	Universitätsklinik Göttingen	Gottingen
Germany	University Hospital Schleswig-Holstein Campus Kiel	Kiel
Germany	Technische Universität München	Munich
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Universitari Germans Trias i Pujols	Barcelona
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

Austria,  Germany,  Spain,  Sweden, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revascularization Status	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]	Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment	No
Secondary	Clinical Outcomes at 90 Days	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.; https://en.wikipedia.org/wiki/Modified_Rankin_Scale	90-day	No
Secondary	Mortality at 90 Days	All cause mortality through 90 days post procedure.	90-day	Yes