Trial Outcomes & Findings for Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO) (NCT NCT01088672)

Results Overview

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\[PubMed\]

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment

Results posted on

2015-07-17

Participant Flow

Participant milestones

Participant milestones
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 Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Ischemic Stroke n=60 Participants 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.
Age, Continuous	64.7 years STANDARD_DEVIATION 13.4 • n=99 Participants
Sex: Female, Male Female	33 Participants n=99 Participants
Sex: Female, Male Male	27 Participants n=99 Participants
Region of Enrollment Spain	22 participants n=99 Participants
Region of Enrollment Austria	16 participants n=99 Participants
Region of Enrollment Germany	19 participants n=99 Participants
Region of Enrollment Sweden	3 participants n=99 Participants
NIHSS	17.7 units on a scale STANDARD_DEVIATION 4.8 • n=99 Participants

PRIMARY outcome

Timeframe: 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\[PubMed\]

Outcome measures

Outcome measures
Measure	Acute Ischemic Stroke n=60 Participants 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.
Revascularization Status	92 percentage of subjects TICI 2 or >

SECONDARY outcome

Timeframe: 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. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. https://en.wikipedia.org/wiki/Modified\_Rankin\_Scale

Outcome measures

Outcome measures
Measure	Acute Ischemic Stroke n=60 Participants 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.
Clinical Outcomes at 90 Days	55 percentage of subjects with mrs 0-2

SECONDARY outcome

Timeframe: 90-day

All cause mortality through 90 days post procedure.

Outcome measures

Outcome measures
Measure	Acute Ischemic Stroke n=60 Participants 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.
Mortality at 90 Days	12 participants

Adverse Events

Acute Ischemic Stroke

Serious events: 12 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Acute Ischemic Stroke n=60 participants at risk 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.
Vascular disorders Death	20.0% 12/60 • Number of events 12 • 90 days All events adjudicated by CEC
Vascular disorders SICH	8.3% 5/60 • Number of events 5 • 90 days All events adjudicated by CEC
Vascular disorders Perforation	1.7% 1/60 • Number of events 1 • 90 days All events adjudicated by CEC

Other adverse events

Other adverse events
Measure	Acute Ischemic Stroke n=60 participants at risk 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.
Vascular disorders Asymptomatic hemorrhage	5.0% 3/60 • Number of events 3 • 90 days All events adjudicated by CEC

Additional Information

Amelia Saliba, AIS Clinical Program Manager

Stryker NV

Phone: 510-413-2500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60