Trial Outcomes & Findings for Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke (NCT NCT01270867)

Last Updated: 2015-08-03

Results Overview

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\[PubMed\]

Recruitment status

COMPLETED

Study phase

Target enrollment

178 participants

Primary outcome timeframe

acute/procedural

Results posted on

2015-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Merci Retriever Patients who were randomized to the Merci Retriever	Trevo Stentriever Patients who were randomized to the Trevo Stentriever
Overall Study STARTED	90	88
Overall Study COMPLETED	89	88
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Merci Retriever n=90 Participants Patients who were randomized to the Merci Retriever	Trevo Stentriever n=88 Participants Patients who were randomized to the Trevo Stentriever	Total n=178 Participants Total of all reporting groups
Age, Continuous	67.0 years STANDARD_DEVIATION 14.7 • n=5 Participants	67.4 years STANDARD_DEVIATION 13.9 • n=7 Participants	67.2 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	48 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	40 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment United States	89 participants n=5 Participants	88 participants n=7 Participants	177 participants n=5 Participants
Region of Enrollment Spain	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: acute/procedural

Population: 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%.

Outcome measures

Outcome measures
Measure	Merci Retriever n=90 Participants Patients who were randomized to receive the Merci Retriever.	Trevo Stentriever n=88 Participants Patients who were randomized to receive the Trevo Stentriever.
Primary Efficacy Endpoint	54 participants	76 participants

PRIMARY outcome

Timeframe: within 24 hours of procedure

Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).

Outcome measures

Outcome measures
Measure	Merci Retriever n=90 Participants Patients who were randomized to receive the Merci Retriever.	Trevo Stentriever n=88 Participants Patients who were randomized to receive the Trevo Stentriever.
Primary Safety Endpoint	21 participants	13 participants

SECONDARY outcome

Timeframe: 90 days

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

Outcome measures

Outcome measures
Measure	Merci Retriever n=87 Participants Patients who were randomized to receive the Merci Retriever.	Trevo Stentriever n=85 Participants Patients who were randomized to receive the Trevo Stentriever.
Secondary Endpoint	19 participants	34 participants

SECONDARY outcome

Timeframe: procedure through 90 days

All cause mortality at 90 days

Outcome measures

Outcome measures
Measure	Merci Retriever n=89 Participants Patients who were randomized to receive the Merci Retriever.	Trevo Stentriever n=88 Participants Patients who were randomized to receive the Trevo Stentriever.
Secondary Endpoint	21 participants	29 participants

SECONDARY outcome

Timeframe: 24 hours

Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure

Outcome measures

Outcome measures
Measure	Merci Retriever n=90 Participants Patients who were randomized to receive the Merci Retriever.	Trevo Stentriever n=88 Participants Patients who were randomized to receive the Trevo Stentriever.
Secondary Endpoint	48 participants	36 participants

Adverse Events

Merci Retriever

Serious events: 39 serious events

Other events: 73 other events

Deaths: 0 deaths

Trevo Stentriever

Serious events: 41 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Paula Schmidt, Clinical Project Manager

Concentric Medical / Stryker Neurovascular Inc

Phone: 510-413-2271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	Merci Retriever n=90 participants at risk Patients who were randomized to receive the Merci Retriever.	Trevo Stentriever n=88 participants at risk Patients who were randomized to receive the Trevo Stentriever.
Nervous system disorders Cerebral Edema	8.9% 8/90 • Number of events 8 • Each subject was followed for 90 days; The study period was 1 year. 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.	11.4% 10/88 • Number of events 11 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Acute Mental Status Change/Confusion	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Headache	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Dysphagia (Difficulty Swallowing)	4.4% 4/90 • Number of events 4 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Transient Ischemic Attack (TIA)	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	2.3% 2/88 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Hydrocephalus	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders IVH	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders SAH	5.6% 5/90 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.	3.4% 3/88 • Number of events 3 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders ICH - HI -1	4.4% 4/90 • Number of events 4 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders ICH - HI -2	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders ICH - PH1	5.6% 5/90 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.	5.7% 5/88 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders ICH - PH2	3.3% 3/90 • Number of events 3 • Each subject was followed for 90 days; The study period was 1 year. 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.	3.4% 3/88 • Number of events 3 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Neurologic Decline	2.2% 2/90 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.	5.7% 5/88 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders New Ischemic Stroke	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Late ICH	2.2% 2/90 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.	2.3% 2/88 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Depression	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Progression of index Stroke	6.7% 6/90 • Number of events 6 • Each subject was followed for 90 days; The study period was 1 year. 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.	9.1% 8/88 • Number of events 8 • Each subject was followed for 90 days; The study period was 1 year. 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.
Vascular disorders Reocclusion at the site of original occlusion or proximal to original occlusion	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Seizure - New Onset	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Unresponsiveness	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Arrhythmia - Tachycardia	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Atrial Fibrillation	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Cardiac Arrest	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Cardiopulmonary Arrest	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Chest Pain	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	2.3% 2/88 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Congestive Heart Failure	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Hypotension - Sustained - Tx	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	2.3% 2/88 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Stress Cardiomyopathy	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Skin and subcutaneous tissue disorders Other	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Gastrointestinal disorders GI Bleed	2.2% 2/90 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Gastrointestinal disorders Other	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Gastrointestinal disorders Occult Blood	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Metabolism and nutrition disorders Electrolyte Imbalance	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Metabolism and nutrition disorders Other	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Musculoskeletal and connective tissue disorders Joint/Extremity Pain	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Surgical and medical procedures Access Site Complication	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	2.3% 2/88 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.
Surgical and medical procedures Intramural Arterial Dissection	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Respiratory, thoracic and mediastinal disorders Hemoptysis (bloody sputum)	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/90 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.1% 1/90 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.	2.3% 2/88 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.

Other adverse events
Measure	Merci Retriever n=90 participants at risk Patients who were randomized to receive the Merci Retriever.	Trevo Stentriever n=88 participants at risk Patients who were randomized to receive the Trevo Stentriever.
Nervous system disorders Cerebral Edema	8.9% 8/90 • Number of events 8 • Each subject was followed for 90 days; The study period was 1 year. 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.	4.5% 4/88 • Number of events 4 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Headache	8.9% 8/90 • Number of events 8 • Each subject was followed for 90 days; The study period was 1 year. 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.	9.1% 8/88 • Number of events 9 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Dysphagia (Difficulty Swallowing)	22.2% 20/90 • Number of events 20 • Each subject was followed for 90 days; The study period was 1 year. 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.	15.9% 14/88 • Number of events 14 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders SAH	8.9% 8/90 • Number of events 8 • Each subject was followed for 90 days; The study period was 1 year. 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.	1.1% 1/88 • Number of events 1 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders ICH - HI -1	7.8% 7/90 • Number of events 7 • Each subject was followed for 90 days; The study period was 1 year. 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.	8.0% 7/88 • Number of events 7 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders ICH - PH1	8.9% 8/90 • Number of events 8 • Each subject was followed for 90 days; The study period was 1 year. 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.	4.5% 4/88 • Number of events 4 • Each subject was followed for 90 days; The study period was 1 year. 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.
Nervous system disorders Neurologic Decline	6.7% 6/90 • Number of events 6 • Each subject was followed for 90 days; The study period was 1 year. 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.	0.00% 0/88 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Arrhythmia - Tachycardia	4.4% 4/90 • Number of events 4 • Each subject was followed for 90 days; The study period was 1 year. 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.	5.7% 5/88 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.
Cardiac disorders Atrial Fibrillation	6.7% 6/90 • Number of events 6 • Each subject was followed for 90 days; The study period was 1 year. 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.	10.2% 9/88 • Number of events 9 • Each subject was followed for 90 days; The study period was 1 year. 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.
Gastrointestinal disorders Constipation	5.6% 5/90 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.	2.3% 2/88 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.
Gastrointestinal disorders Nausea and Vomiting (Non-Neuro)	3.3% 3/90 • Number of events 3 • Each subject was followed for 90 days; The study period was 1 year. 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.	9.1% 8/88 • Number of events 8 • Each subject was followed for 90 days; The study period was 1 year. 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.
Blood and lymphatic system disorders Anemia	18.9% 17/90 • Number of events 17 • Each subject was followed for 90 days; The study period was 1 year. 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.	15.9% 14/88 • Number of events 14 • Each subject was followed for 90 days; The study period was 1 year. 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.
Metabolism and nutrition disorders Hyperglycemia	11.1% 10/90 • Number of events 10 • Each subject was followed for 90 days; The study period was 1 year. 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.	9.1% 8/88 • Number of events 8 • Each subject was followed for 90 days; The study period was 1 year. 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.
Metabolism and nutrition disorders Electrolyte Imbalance	26.7% 24/90 • Number of events 32 • Each subject was followed for 90 days; The study period was 1 year. 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.	17.0% 15/88 • Number of events 22 • Each subject was followed for 90 days; The study period was 1 year. 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.
Musculoskeletal and connective tissue disorders Joint/Extremity Pain	11.1% 10/90 • Number of events 13 • Each subject was followed for 90 days; The study period was 1 year. 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.	5.7% 5/88 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	23.3% 21/90 • Number of events 22 • Each subject was followed for 90 days; The study period was 1 year. 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.	10.2% 9/88 • Number of events 10 • Each subject was followed for 90 days; The study period was 1 year. 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.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	5.6% 5/90 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.	4.5% 4/88 • Number of events 4 • Each subject was followed for 90 days; The study period was 1 year. 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.
Respiratory, thoracic and mediastinal disorders Respiratory Failure - Acute	6.7% 6/90 • Number of events 6 • Each subject was followed for 90 days; The study period was 1 year. 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.	3.4% 3/88 • Number of events 3 • Each subject was followed for 90 days; The study period was 1 year. 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.
Vascular disorders Deep Vein Thrombosis (DVT)	13.3% 12/90 • Number of events 12 • Each subject was followed for 90 days; The study period was 1 year. 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.	10.2% 9/88 • Number of events 10 • Each subject was followed for 90 days; The study period was 1 year. 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.
General disorders Fever	5.6% 5/90 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.	4.5% 4/88 • Number of events 4 • Each subject was followed for 90 days; The study period was 1 year. 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.
General disorders Positive Cultures	7.8% 7/90 • Number of events 7 • Each subject was followed for 90 days; The study period was 1 year. 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.	3.4% 3/88 • Number of events 3 • Each subject was followed for 90 days; The study period was 1 year. 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.
Renal and urinary disorders Urinary Tract Infection	20.0% 18/90 • Number of events 19 • Each subject was followed for 90 days; The study period was 1 year. 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.	15.9% 14/88 • Number of events 15 • Each subject was followed for 90 days; The study period was 1 year. 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.
Renal and urinary disorders Hematuria	1.1% 1/90 • Number of events 2 • Each subject was followed for 90 days; The study period was 1 year. 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.	6.8% 6/88 • Number of events 6 • Each subject was followed for 90 days; The study period was 1 year. 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.
Renal and urinary disorders Urinary Retention	5.6% 5/90 • Number of events 5 • Each subject was followed for 90 days; The study period was 1 year. 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.	3.4% 3/88 • Number of events 3 • Each subject was followed for 90 days; The study period was 1 year. 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.