Trial Outcomes & Findings for The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study) (NCT NCT01958294)
NCT ID: NCT01958294
Last Updated: 2020-01-18
Results Overview
Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
30-days post-procedurally
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
MICHI Neuroprotection System
Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System The MICHI Neuroprotection System (MICHI NPS) is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.
The system permits transcervical access to the carotid lesion, and the flow reversal through the circuit re-directs emboli that are liberated during carotid angioplasty and stent delivery.
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
MICHI Neuroprotection System
Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System The MICHI Neuroprotection System (MICHI NPS) is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.
The system permits transcervical access to the carotid lesion, and the flow reversal through the circuit re-directs emboli that are liberated during carotid angioplasty and stent delivery.
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Overall Study
Clinical Circumstances
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2
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Baseline Characteristics
The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)
Baseline characteristics by cohort
| Measure |
MICHI Neuroprotection System
n=12 Participants
Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System
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Age, Customized
70-74 years of age
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8 participants
n=99 Participants
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Age, Customized
75-79 years of age
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2 participants
n=99 Participants
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Age, Customized
80 years of age and older
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1 participants
n=99 Participants
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Age, Customized
Unknown or not reported
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1 participants
n=99 Participants
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Sex: Female, Male
Female
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5 Participants
n=99 Participants
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Sex: Female, Male
Male
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7 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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12 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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12 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United Kingdom
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12 participants
n=99 Participants
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Average Height
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163.8 cm
STANDARD_DEVIATION 7.4 • n=99 Participants
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Average Weight
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71.7 kg
STANDARD_DEVIATION 12.7 • n=99 Participants
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PRIMARY outcome
Timeframe: 30-days post-procedurallyPopulation: Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.
Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.
Outcome measures
| Measure |
MICHI Neuroprotection System
n=10 Participants
Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System
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Composite of Any Stroke, Myocardial Infarction and Death
Myocardial Infarction
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1 participants
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Composite of Any Stroke, Myocardial Infarction and Death
Stroke
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0 participants
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Composite of Any Stroke, Myocardial Infarction and Death
Death
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0 participants
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SECONDARY outcome
Timeframe: Intra procedural (1 day)Population: Subjects meeting the description of the outcome measures in which vascular access was achieved, reverse flow was successfully established, and the device retrieved from the vasculature.
Acute device success - Defined as MICHI™ NPS was delivered (vascular access achieved), reverse flow was attempted and established and the device retrieved / removed from vasculature.
Outcome measures
| Measure |
MICHI Neuroprotection System
n=10 Participants
Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System
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Acute Device Success
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10 participants
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SECONDARY outcome
Timeframe: Through 30-day Follow-up periodPopulation: Successful delivery of therapeutic devices (balloons, stents, etc.) through the Transcervical Arterial Sheath and ability to provide embolic protection throughout the procedure with freedom from device related Major Adverse Events at 30 days
Procedure Success - Procedural success is the ability to deliver therapeutic devices (balloons, stents, etc.) through the Transcervical Arterial Sheath and the ability to provide embolic protection throughout the procedure with the freedom of device related Major Adverse Events at 30 days.
Outcome measures
| Measure |
MICHI Neuroprotection System
n=10 Participants
Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System
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Procedural Success
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9 participants
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Adverse Events
MICHI Neuroprotection System
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MICHI Neuroprotection System
n=12 participants at risk
Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System
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Vascular disorders
Hematoma
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16.7%
2/12 • Number of events 2 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Other adverse events
| Measure |
MICHI Neuroprotection System
n=12 participants at risk
Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System
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Cardiac disorders
Bradycardia
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Cardiac disorders
Dyspnea
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Cardiac disorders
Myocardial Infarction
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Gastrointestinal disorders
Constipation
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Gastrointestinal disorders
Indigestion
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Gastrointestinal disorders
Vomiting
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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General disorders
Pain
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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General disorders
Pyrexia
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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General disorders
Swelling
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Injury, poisoning and procedural complications
Procedural Complication (Transient Intolerance)
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Injury, poisoning and procedural complications
Vascular Procedure Complication
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Investigations
Blood Troponin, CK or CK-MB Increased
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16.7%
2/12 • Number of events 2 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Investigations
Full Blood Count Abnormal
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16.7%
2/12 • Number of events 2 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Investigations
Hemoglobin Decreased
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16.7%
2/12 • Number of events 2 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Nervous system disorders
Dizziness
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Nervous system disorders
Headache
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Nervous system disorders
Right Arm Drift
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Nervous system disorders
Transient Ischemic Attack
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Vascular disorders
Hematoma
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50.0%
6/12 • Number of events 6 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Vascular disorders
Hemorrhage/Oozing
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50.0%
6/12 • Number of events 6 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Vascular disorders
Hypertension
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33.3%
4/12 • Number of events 4 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Vascular disorders
Hypotension
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8.3%
1/12 • Number of events 1 • 0 to 30 days following study index procedure
The protocol's primary endpoint was to capture MAEs, or Major Adverse Events, which differ from the ClinicalTrials.gov definition of Serious Adverse Events in that they only include Myocardial Infarction, Stroke and Death as determined by a Central Adjudication Committee (CEC), however, despite this difference, MAEs, SAES and AEs were all captured for documentation and data purposes.
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Additional Information
Ric Ruedy, Exec VP, Clinical Affairs
Silk Road Medical, Inc.
Phone: 408-585-2112
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60