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Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke (TREVO2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01270867
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : February 27, 2014
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ischemic Stroke
Intervention Device: Mechanical Thrombectomy
Enrollment 178
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Merci Retriever Trevo Stentriever
Hide Arm/Group Description Patients who were randomized to the Merci Retriever Patients who were randomized to the Trevo Stentriever
Period Title: Overall Study
Started 90 88
Completed 89 88
Not Completed 1 0
Arm/Group Title Merci Retriever Trevo Stentriever Total
Hide Arm/Group Description Patients who were randomized to the Merci Retriever Patients who were randomized to the Trevo Stentriever Total of all reporting groups
Overall Number of Baseline Participants 90 88 178
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 88 participants 178 participants
67.0  (14.7) 67.4  (13.9) 67.2  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 88 participants 178 participants
Female
54
  60.0%
48
  54.5%
102
  57.3%
Male
36
  40.0%
40
  45.5%
76
  42.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 88 participants 178 participants
United States 89 88 177
Spain 1 0 1
1.Primary Outcome
Title Primary Efficacy Endpoint
Hide Description

Revascularization of the occluded territory, defined as at least TICI 2 flow in the treated territory after use of the assigned device.

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 acute/procedural
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis was performed. The non-inferiority hypothesis was tested with Blackwelder's method, assuming a one-sided alpha=0.025 and a clinically relevant non-inferiority margin of 10%.
Arm/Group Title Merci Retriever Trevo Stentriever
Hide Arm/Group Description:
Patients who were randomized to receive the Merci Retriever.
Patients who were randomized to receive the Trevo Stentriever.
Overall Number of Participants Analyzed 90 88
Measure Type: Number
Unit of Measure: participants
54 76
2.Primary Outcome
Title Primary Safety Endpoint
Hide Description Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).
Time Frame within 24 hours of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Merci Retriever Trevo Stentriever
Hide Arm/Group Description:
Patients who were randomized to receive the Merci Retriever.
Patients who were randomized to receive the Trevo Stentriever.
Overall Number of Participants Analyzed 90 88
Measure Type: Number
Unit of Measure: participants
21 13
3.Secondary Outcome
Title Secondary Endpoint
Hide Description

Good clinical outcomes at 90 days, as assessed by mRS (a "good" clinical outcome is defined as mRS </= 2)

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_Sca
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Merci Retriever Trevo Stentriever
Hide Arm/Group Description:
Patients who were randomized to receive the Merci Retriever.
Patients who were randomized to receive the Trevo Stentriever.
Overall Number of Participants Analyzed 87 85
Measure Type: Number
Unit of Measure: participants
19 34
4.Secondary Outcome
Title Secondary Endpoint
Hide Description All cause mortality at 90 days
Time Frame procedure through 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Merci Retriever Trevo Stentriever
Hide Arm/Group Description:
Patients who were randomized to receive the Merci Retriever.
Patients who were randomized to receive the Trevo Stentriever.
Overall Number of Participants Analyzed 89 88
Measure Type: Number
Unit of Measure: participants
21 29
5.Secondary Outcome
Title Secondary Endpoint
Hide Description Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Merci Retriever Trevo Stentriever
Hide Arm/Group Description:
Patients who were randomized to receive the Merci Retriever.
Patients who were randomized to receive the Trevo Stentriever.
Overall Number of Participants Analyzed 90 88
Measure Type: Number
Unit of Measure: participants
48 36
Time Frame Each subject was followed for 90 days; The study period was 1 year.
Adverse Event Reporting Description

A study specific AE classification system was used to categorize Site Reported AEs and SAEs.

The study used an independent clinical events committee, CT and MRI imaging core laboratory, a separate angiography core laboratory, and an independent data safety and monitoring board (DSMB) to ensure appropriate oversight and analysis.

 
Arm/Group Title Merci Retriever Trevo Stentriever
Hide Arm/Group Description Patients who were randomized to receive the Merci Retriever. Patients who were randomized to receive the Trevo Stentriever.
All-Cause Mortality
Merci Retriever Trevo Stentriever
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Merci Retriever Trevo Stentriever
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/90 (43.33%)      41/88 (46.59%)    
Cardiac disorders     
Arrhythmia - Tachycardia   0/90 (0.00%)  0 1/88 (1.14%)  1
Atrial Fibrillation   1/90 (1.11%)  1 0/88 (0.00%)  0
Cardiac Arrest   0/90 (0.00%)  0 1/88 (1.14%)  1
Cardiopulmonary Arrest   0/90 (0.00%)  0 1/88 (1.14%)  1
Chest Pain   0/90 (0.00%)  0 2/88 (2.27%)  2
Congestive Heart Failure   1/90 (1.11%)  1 1/88 (1.14%)  1
Hypotension - Sustained - Tx   1/90 (1.11%)  1 2/88 (2.27%)  2
Stress Cardiomyopathy   1/90 (1.11%)  1 0/88 (0.00%)  0
Gastrointestinal disorders     
GI Bleed   2/90 (2.22%)  2 0/88 (0.00%)  0
Other   1/90 (1.11%)  1 0/88 (0.00%)  0
Occult Blood   1/90 (1.11%)  1 1/88 (1.14%)  1
General disorders     
Drug Reaction   1/90 (1.11%)  1 1/88 (1.14%)  1
Fever   1/90 (1.11%)  1 0/88 (0.00%)  0
Positive Cultures   0/90 (0.00%)  0 1/88 (1.14%)  1
Events With an Outcome of Death   2/90 (2.22%)  2 1/88 (1.14%)  1
Infections and infestations     
Sepsis   1/90 (1.11%)  1 1/88 (1.14%)  1
Metabolism and nutrition disorders     
Electrolyte Imbalance   0/90 (0.00%)  0 1/88 (1.14%)  1
Other   0/90 (0.00%)  0 1/88 (1.14%)  1
Musculoskeletal and connective tissue disorders     
Joint/Extremity Pain   0/90 (0.00%)  0 1/88 (1.14%)  1
Nervous system disorders     
Acute Mental Status Change/Confusion   1/90 (1.11%)  1 0/88 (0.00%)  0
Cerebral Edema   8/90 (8.89%)  8 10/88 (11.36%)  11
Headache   0/90 (0.00%)  0 1/88 (1.14%)  1
Dysphagia (Difficulty Swallowing)   4/90 (4.44%)  4 1/88 (1.14%)  1
Transient Ischemic Attack (TIA)   0/90 (0.00%)  0 2/88 (2.27%)  2
Hydrocephalus   0/90 (0.00%)  0 1/88 (1.14%)  1
IVH   0/90 (0.00%)  0 1/88 (1.14%)  1
SAH   5/90 (5.56%)  5 3/88 (3.41%)  3
ICH - HI -1   4/90 (4.44%)  4 0/88 (0.00%)  0
ICH - HI -2   1/90 (1.11%)  1 1/88 (1.14%)  1
ICH - PH1   5/90 (5.56%)  5 5/88 (5.68%)  5
ICH - PH2   3/90 (3.33%)  3 3/88 (3.41%)  3
Neurologic Decline   2/90 (2.22%)  2 5/88 (5.68%)  5
New Ischemic Stroke   0/90 (0.00%)  0 1/88 (1.14%)  1
Late ICH   2/90 (2.22%)  2 2/88 (2.27%)  2
Depression   1/90 (1.11%)  1 0/88 (0.00%)  0
Progression of index Stroke   6/90 (6.67%)  6 8/88 (9.09%)  8
Seizure - New Onset   1/90 (1.11%)  1 0/88 (0.00%)  0
Unresponsiveness   0/90 (0.00%)  0 1/88 (1.14%)  1
Renal and urinary disorders     
Urinary Tract Infection   1/90 (1.11%)  1 1/88 (1.14%)  1
Respiratory, thoracic and mediastinal disorders     
Hemoptysis (bloody sputum)   1/90 (1.11%)  1 0/88 (0.00%)  0
Pleural Effusion   0/90 (0.00%)  0 1/88 (1.14%)  1
Pneumonia   1/90 (1.11%)  1 2/88 (2.27%)  2
Pulmonary Emboli   0/90 (0.00%)  0 1/88 (1.14%)  1
Respiratory Arrest   1/90 (1.11%)  1 0/88 (0.00%)  0
Respiratory Distress   1/90 (1.11%)  1 7/88 (7.95%)  7
Respiratory Failure - Acute   13/90 (14.44%)  13 3/88 (3.41%)  3
Shortness of Breath   0/90 (0.00%)  0 1/88 (1.14%)  1
Tachypnea   0/90 (0.00%)  0 1/88 (1.14%)  1
Skin and subcutaneous tissue disorders     
Other   0/90 (0.00%)  0 1/88 (1.14%)  1
Surgical and medical procedures     
Access Site Complication   0/90 (0.00%)  0 2/88 (2.27%)  2
Intramural Arterial Dissection   1/90 (1.11%)  1 0/88 (0.00%)  0
Vascular disorders     
Reocclusion at the site of original occlusion or proximal to original occlusion   1/90 (1.11%)  1 0/88 (0.00%)  0
Deep Vein Thrombosis (DVT)   1/90 (1.11%)  1 3/88 (3.41%)  3
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Merci Retriever Trevo Stentriever
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   73/90 (81.11%)      71/88 (80.68%)    
Blood and lymphatic system disorders     
Anemia   17/90 (18.89%)  17 14/88 (15.91%)  14
Cardiac disorders     
Arrhythmia - Tachycardia   4/90 (4.44%)  4 5/88 (5.68%)  5
Atrial Fibrillation   6/90 (6.67%)  6 9/88 (10.23%)  9
Gastrointestinal disorders     
Constipation   5/90 (5.56%)  5 2/88 (2.27%)  2
Nausea and Vomiting (Non-Neuro)   3/90 (3.33%)  3 8/88 (9.09%)  8
General disorders     
Fever   5/90 (5.56%)  5 4/88 (4.55%)  4
Positive Cultures   7/90 (7.78%)  7 3/88 (3.41%)  3
Metabolism and nutrition disorders     
Hyperglycemia   10/90 (11.11%)  10 8/88 (9.09%)  8
Electrolyte Imbalance   24/90 (26.67%)  32 15/88 (17.05%)  22
Musculoskeletal and connective tissue disorders     
Joint/Extremity Pain   10/90 (11.11%)  13 5/88 (5.68%)  5
Nervous system disorders     
Cerebral Edema   8/90 (8.89%)  8 4/88 (4.55%)  4
Headache   8/90 (8.89%)  8 8/88 (9.09%)  9
Dysphagia (Difficulty Swallowing)   20/90 (22.22%)  20 14/88 (15.91%)  14
SAH   8/90 (8.89%)  8 1/88 (1.14%)  1
ICH - HI -1   7/90 (7.78%)  7 7/88 (7.95%)  7
ICH - PH1   8/90 (8.89%)  8 4/88 (4.55%)  4
Neurologic Decline   6/90 (6.67%)  6 0/88 (0.00%)  0
Renal and urinary disorders     
Urinary Tract Infection   18/90 (20.00%)  19 14/88 (15.91%)  15
Hematuria   1/90 (1.11%)  2 6/88 (6.82%)  6
Urinary Retention   5/90 (5.56%)  5 3/88 (3.41%)  3
Respiratory, thoracic and mediastinal disorders     
Pneumonia   21/90 (23.33%)  22 9/88 (10.23%)  10
Pulmonary Edema   5/90 (5.56%)  5 4/88 (4.55%)  4
Respiratory Failure - Acute   6/90 (6.67%)  6 3/88 (3.41%)  3
Vascular disorders     
Deep Vein Thrombosis (DVT)   12/90 (13.33%)  12 9/88 (10.23%)  10
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paula Schmidt, Clinical Project Manager
Organization: Concentric Medical / Stryker Neurovascular Inc
Phone: 510-413-2271
EMail: paula.schmidt@stryker.com
Layout table for additonal information
Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT01270867    
Other Study ID Numbers: DQR0038
First Submitted: January 4, 2011
First Posted: January 5, 2011
Results First Submitted: November 20, 2013
Results First Posted: February 27, 2014
Last Update Posted: August 3, 2015