Trial Outcomes & Findings for Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms (NCT NCT01801007)
NCT ID: NCT01801007
Last Updated: 2021-03-08
Results Overview
The primary effectiveness endpoint has three components: 1) complete occlusion of the target aneurysm assessed by a core laboratory utilizing the Raymond-Roy Scale 2) ≤ 50% stenosis of the parent artery at the target (IA) using the Warfarin-Aspirin Symptomatic Intracranial Disease(WASID) criterion which is defined as greater than 50% luminal loss, 3) alternative treatment of the target IA is defined as re-treatment of the target aneurysm with an alternative treatment modality including open repair, endovascular placement of an additional stent or treatment of In-stent Stenosis observed. The Raymond-Roy Occlusion Classification has 3 responses, where Grade I is complete occlusion, no flow of contrast seen in the sac, Grade II is partial occlusion, some flow in the neck or sac, and Grade III is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.
COMPLETED
NA
145 participants
12 months
2021-03-08
Participant Flow
Participant milestones
| Measure |
Flow Re-Direction Endoluminal Device
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Overall Study
STARTED
|
145
|
|
Overall Study
COMPLETED
|
134
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Flow Re-Direction Endoluminal Device
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
Baseline characteristics by cohort
| Measure |
Flow Re-Direction Endoluminal Device
n=145 Participants
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
139 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants that had 12 month angiographic assessment of vessel stenosis
The primary effectiveness endpoint has three components: 1) complete occlusion of the target aneurysm assessed by a core laboratory utilizing the Raymond-Roy Scale 2) ≤ 50% stenosis of the parent artery at the target (IA) using the Warfarin-Aspirin Symptomatic Intracranial Disease(WASID) criterion which is defined as greater than 50% luminal loss, 3) alternative treatment of the target IA is defined as re-treatment of the target aneurysm with an alternative treatment modality including open repair, endovascular placement of an additional stent or treatment of In-stent Stenosis observed. The Raymond-Roy Occlusion Classification has 3 responses, where Grade I is complete occlusion, no flow of contrast seen in the sac, Grade II is partial occlusion, some flow in the neck or sac, and Grade III is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.
Outcome measures
| Measure |
Flow Re-Direction Endoluminal Device
n=139 Participants
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Percentage of Participants With Complete Occlusion of the Target Aneurysm and ≤50% Stenosis of the Parent Artery and an Alternative Treatment of the Target Intracranial Aneurysm (IA) Had Not Been Performed Within 12 Months
|
57.0 percentage of participants
|
PRIMARY outcome
Timeframe: 12 monthsA major stroke is defined as a new neurological event that persists for \> 24 hours and results in a ≥ 4 points increase in the NIHSS score compared to baseline or compared to any subsequent lower score. A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery. Neurologic death is defined as a death which has been adjudicated by the independent clinical events committee to have directly resulted from a neurologic cause.The NIHSS score ranges from 0 (no stroke symptoms) to 42 (severe stroke). mRS is 6 point assessment scale used to assess disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. The mRS score ranges from 0 (no disability) to 6 (death).
Outcome measures
| Measure |
Flow Re-Direction Endoluminal Device
n=145 Participants
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Percentage of Participants Who Experience Neurological Death or Major Ipsilateral Stroke Measured by the Modified Rankin Scale (mRS) and the National Institute of Health Stroke Scale (NIHSS)
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants that had 12 month angiographic assessment of aneurysm occlusion and vessel stenosis.
Complete occlusion of the target aneurysm assessed by a core laboratory. The Raymond-Roy class is an angiographic classification scheme for grading the occlusion (closure) of endovascularly treated intracranial aneurysms: class I: complete obliteration, class II: residual neck, class III: residual aneurysm.
Outcome measures
| Measure |
Flow Re-Direction Endoluminal Device
n=140 Participants
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Percentage of Participants With Complete Occlusion of the Target Aneurysm on 12-month Angiography (Raymond-Roy 1)
|
88 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants that had 12 month angiographic assessment of vessel stenosis.
Stenosis of the parent artery at the target IA using the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) criterion which is defined as greater than 50% luminal loss
Outcome measures
| Measure |
Flow Re-Direction Endoluminal Device
n=139 Participants
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Percentage of Participants With ≥ 50% In-Stent Stenosis (ISS) at the Target Intracranial Aneurysm (IA) at 12 Months as Assessed by Angiography at the Independent Core Laboratory
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants that had 12 months angiographic assessment and vessel stenosis.
Re-treatment of the target aneurysm with an alternative treatment modality including open repair, endovascular placement of an additional stent or treatment of In-stent Stenosis observed
Outcome measures
| Measure |
Flow Re-Direction Endoluminal Device
n=140 Participants
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Percentage of Participants in Whom an Unplanned Alternative Treatment of the Target IA Had Not Been Performed Within 12 Months
|
132 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants that had 12 month angiographic assessment of vessel stenosis.
This endpoint has three components: 1) clinically acceptable occlusion of the target aneurysm assessed by a core laboratory as percent occlusion (90%-100%) 2) ≤ 50% stenosis of the parent artery at the target IA using the WASID criterion which is defined as greater than 50% luminal loss, 3) alternative treatment of the target IA is defined as re-treatment of the target aneurysm with an alternative treatment modality including open repair, endovascular placement of an additional stent or treatment of In-stent Stenosis observed. The Raymond-Roy scale has 3 responses, where Grade I is complete occlusion, no flow of contrast seen in the sac, Grade II is partial occlusion, some flow in the neck or sac, and Grade III is incomplete occlusion, apparent flow into the sac.
Outcome measures
| Measure |
Flow Re-Direction Endoluminal Device
n=139 Participants
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Percentage of Participants With Clinically Acceptable (90-100%) Occlusion of the Target Aneurysm, ≤ 50% Stenosis of the Parent Artery at the Target IA, and an Unplanned Alternative Treatment of the Target IA Had Not Been Performed
|
100 Participants
|
SECONDARY outcome
Timeframe: Index ProcedureInability to deliver a FRED device to the target location
Outcome measures
| Measure |
Flow Re-Direction Endoluminal Device
n=145 Participants
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Percentage of Participants With Unsuccessful Delivery of the FRED
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsA serious adverse event is any medical experience regardless of its relationship to the study treatment that occurs during participant enrollment in this trial that results in any of the following: (1) inpatient hospitalization or prolongation of a hospitalization; (b) persistent or significant disability or incapacity; (c) death of the study participant, or (d) necessitates an intervention to prevent a permanent impairment of a body function or permanent damage to a body structure. Procedure related events were associated with the index procedure, antiplatelet therapy, or follow up angiography.
Outcome measures
| Measure |
Flow Re-Direction Endoluminal Device
n=145 Participants
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Percentage of Participants That Had Procedure Related Serious Adverse Events With the FRED System
|
40 Participants
|
Adverse Events
Flow Re-Direction Endoluminal Device
Serious adverse events
| Measure |
Flow Re-Direction Endoluminal Device
n=145 participants at risk
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Cardiac disorders
Arrhythmia
|
1.4%
2/145 • Number of events 3 • 12 months
|
|
Eye disorders
Visual impairment
|
1.4%
2/145 • Number of events 2 • 12 months
|
|
Eye disorders
Vision blurred
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastric perforation
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
General disorders
Chest pain
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
General disorders
Device deployment issue
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
General disorders
Device dislocation
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
General disorders
Device failure
|
4.1%
6/145 • Number of events 6 • 12 months
|
|
General disorders
Device malfunction
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
General disorders
Device occlusion
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
General disorders
In-stent cerebral artery stenosis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
General disorders
Puncture site haemorrhage
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
General disorders
Thrombosis in device
|
6.9%
10/145 • Number of events 10 • 12 months
|
|
Infections and infestations
Abdominal abscess
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Infections and infestations
Appendicitis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Infections and infestations
Cellulitis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Infections and infestations
Endocarditis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
1.4%
2/145 • Number of events 2 • 12 months
|
|
Infections and infestations
Sepsis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
1.4%
2/145 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Investigations
Visual field tests abnormal
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.4%
2/145 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer metastatic
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Blindness
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.1%
3/145 • Number of events 3 • 12 months
|
|
Nervous system disorders
Cerebral hypoperfusion
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
4.1%
6/145 • Number of events 6 • 12 months
|
|
Nervous system disorders
Encephalopathy
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Eyelid ptosis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Headache
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Hydrocephalus
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Intracranial pressure increased
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Ischaemic stroke
|
2.8%
4/145 • Number of events 4 • 12 months
|
|
Nervous system disorders
Mental impairment
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Paraesthesia
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Radiculitis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Nervous system disorders
Seizure
|
1.4%
2/145 • Number of events 2 • 12 months
|
|
Nervous system disorders
Transient ischaemic attack
|
3.4%
5/145 • Number of events 5 • 12 months
|
|
Psychiatric disorders
Delirium
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Depression
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
2/145 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Aneurysm repair
|
7.6%
11/145 • Number of events 11 • 12 months
|
|
Surgical and medical procedures
Angioplasty
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Stent placement
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Vascular disorders
Aneurysm
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Vascular disorders
Arterial stenosis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Vascular disorders
Carotid artery stenosis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Vascular disorders
Cerebral vasoconstriction
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Vascular disorders
Femoral artery occlusion
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Vascular disorders
Haematoma
|
0.69%
1/145 • Number of events 1 • 12 months
|
|
Vascular disorders
Vascular wall hypertrophy
|
0.69%
1/145 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Flow Re-Direction Endoluminal Device
n=145 participants at risk
The FRED Stent System is intended to be used in the treatment of wide-necked Intracranial Aneurysms.
|
|---|---|
|
Eye disorders
Visual impairment
|
7.6%
11/145 • Number of events 16 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
6.2%
9/145 • Number of events 9 • 12 months
|
|
Nervous system disorders
Headache
|
29.7%
43/145 • Number of events 45 • 12 months
|
|
Vascular disorders
Haematoma
|
6.2%
9/145 • Number of events 9 • 12 months
|
|
Vascular disorders
Vasospasm
|
11.0%
16/145 • Number of events 17 • 12 months
|
Additional Information
Senior Manager, Clinical Quality Compliance and Clinical Operations
MicroVention, Inc., A TERUMO Group Company
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators must inform and submit to sponsor all manuscripts or abstracts at least 30 days prior to submitting the proposed Publication to a publisher or other third party.
- Publication restrictions are in place
Restriction type: OTHER