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

• Sponsor: Stryker Neurovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01088672
• Collaborator: (none)
• Enrollment: 60
• Locations: 7
• Arm: 1
• Duration (Months): 21
• Patients Per Site: 8.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Procedure: Mechanical Thrombectomy	Phase 4

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO)
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Trevo Procedure

Outcome Measures

Primary Outcome Measures

1. Revascularization Status [Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment]

   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]

Secondary Outcome Measures

1. Clinical Outcomes at 90 Days [90-day]

   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

2. Mortality at 90 Days [90-day]

   All cause mortality through 90 days post procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christian Doppler Clinic	Salzburg		Austria
2	Universitätsklinik Göttingen	Gottingen		Germany
3	University Hospital Schleswig-Holstein Campus Kiel	Kiel		Germany
4	Technische Universität München	Munich		Germany
5	Hospital Clínic de Barcelona	Barcelona		Spain	08036
6	Hospital Universitari Germans Trias i Pujols	Barcelona		Spain
7	Karolinska University Hospital	Stockholm		Sweden

Sponsors and Collaborators

• Stryker Neurovascular

Investigators

• Principal Investigator: Nils Wahlgren, MD, Karolinska University Hospital in Solna
• Principal Investigator: Olav Jansen, MD, Universitätsklinikum Schleswig-Holstein - Campus Kiel UK S-H

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Neurovascular
• ClinicalTrials.gov Identifier: NCT01088672
• Other Study ID Numbers: DQR0036
• First Posted: Mar 17, 2010
• Last Update Posted: Jul 17, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Stryker Neurovascular: Stroke; Ischemic; Thrombus; Embolectomy; Thrombectomy; Concentric; Embolus; Mechanical; Trevo
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia

Study Results

Participant Flow

Arm/Group Title	Acute Ischemic Stroke
Arm/Group Description	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 Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Period Title: Overall Study
STARTED	60
COMPLETED	60
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Acute Ischemic Stroke
Arm/Group Description	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 Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Overall Participants	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.7 (13.4)
Sex: Female, Male (Count of Participants)
Female	33 55%
Male	27 45%
Region of Enrollment (participants) [Number]
Spain	22 36.7%
Austria	16 26.7%
Germany	19 31.7%
Sweden	3 5%
NIHSS (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.7 (4.8)

Outcome Measures

1. Primary Outcome

Title	Revascularization Status
Description	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]
Time Frame	Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Ischemic Stroke
Arm/Group Description	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 Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Measure Participants	60
Number [percentage of subjects TICI 2 or >]	92

2. Secondary Outcome

Title	Clinical Outcomes at 90 Days
Description	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
Time Frame	90-day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Ischemic Stroke
Arm/Group Description	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 Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Measure Participants	60
Number [percentage of subjects with mrs 0-2]	55

3. Secondary Outcome

Title	Mortality at 90 Days
Description	All cause mortality through 90 days post procedure.
Time Frame	90-day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Ischemic Stroke
Arm/Group Description	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 Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Measure Participants	60
Number [participants]	12 20%

Adverse Events

Time Frame	90 days
Adverse Event Reporting Description	All events adjudicated by CEC
Arm/Group Title	Acute Ischemic Stroke
Arm/Group Description	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 Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
All Cause Mortality
	Acute Ischemic Stroke
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Acute Ischemic Stroke
	Affected / at Risk (%)	# Events
Total	12/60 (20%)
Vascular disorders
Death	12/60 (20%)	12
SICH	5/60 (8.3%)	5
Perforation	1/60 (1.7%)	1
Other (Not Including Serious) Adverse Events
	Acute Ischemic Stroke
	Affected / at Risk (%)	# Events
Total	3/60 (5%)
Vascular disorders
Asymptomatic hemorrhage	3/60 (5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.