Trial Outcomes & Findings for Millipede AspiRation for Revascularization in Stroke (MARRS) Study (NCT NCT05714501)
NCT ID: NCT05714501
Last Updated: 2026-07-10
Results Overview
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within ≤3 passes with the Millipede System without additional therapy. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent Core Lab.
COMPLETED
NA
235 participants
Intraprocedural
2026-07-10
Participant Flow
Participant milestones
| Measure |
Millipede System
Aspiration thrombectomy using Millipede System
|
|---|---|
|
Overall Study
STARTED
|
235
|
|
Overall Study
COMPLETED
|
179
|
|
Overall Study
NOT COMPLETED
|
56
|
Reasons for withdrawal
| Measure |
Millipede System
Aspiration thrombectomy using Millipede System
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Eligibility criteria not met
|
55
|
Baseline Characteristics
Millipede AspiRation for Revascularization in Stroke (MARRS) Study
Baseline characteristics by cohort
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
Age, Continuous
|
69.0 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
80 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=9 Participants
|
|
Region of Enrollment
Europe
|
77 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: IntraproceduralPopulation: Intent-to-Treat
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within ≤3 passes with the Millipede System without additional therapy. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
|
160 Participants
|
PRIMARY outcome
Timeframe: From Day 0 (procedure) through to the 90 Day visit.Population: Intent-To-Treat: Imaging available for Core Lab and Clinical Events Committee adjudication of hemorrhagic events
All AEs will be analyzed, with specific attention to the rate of all intracranial hemorrhage (ICH), including symptomatic intracranial hemorrhage (sICH), subarachnoid hemorrhage (SAH), non-hemorrhagic AEs capable of producing neurological deterioration, and death.
Outcome measures
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Primary Safety Outcome
All intracranial hemorrhage at 24 hours
|
55 Participants
|
|
ITT Cohort: Primary Safety Outcome
Symptomatic intracranial hemorrhage at 24 hours
|
4 Participants
|
|
ITT Cohort: Primary Safety Outcome
Subarachnoid hemorrhage at 24 hours
|
6 Participants
|
|
ITT Cohort: Primary Safety Outcome
All-cause mortality at 90 days
|
25 Participants
|
PRIMARY outcome
Timeframe: IntraproceduralPopulation: Intent-to-Treat
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within 3 passes of Millipede System without additional therapy, and where use of any additional therapy after achieving mTICI ≥b with the Millipede System is defined as failure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Outcome measures
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Supplementary Analysis of Primary Effectiveness Endpoint
|
132 Participants
|
PRIMARY outcome
Timeframe: IntraproceduralPopulation: Per-Protocol
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within ≤3 passes with the Millipede System without additional therapy. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=142 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Rate of Core Lab-adjudicated Reperfusion Success Within Three Passes
|
129 Participants
|
PRIMARY outcome
Timeframe: From Day 0 (procedure) through to the 90 Day visit.Population: Per-Protocol: Imaging available for Core Lab and Clinical Events Committee adjudication of hemorrhagic events
All AEs will be analyzed, with specific attention to the rate of all intracranial hemorrhage (ICH), including symptomatic intracranial hemorrhage (sICH), subarachnoid hemorrhage (SAH), non-hemorrhagic AEs capable of producing neurological deterioration, and death.
Outcome measures
| Measure |
Millipede System
n=142 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Primary Safety Outcome
All intracranial hemorrhage at 24 hours
|
39 Participants
|
|
PP Cohort: Primary Safety Outcome
Symptomatic intracranial hemorrhage at 24 hours
|
3 Participants
|
|
PP Cohort: Primary Safety Outcome
Subarachnoid hemorrhage at 24 hours
|
3 Participants
|
|
PP Cohort: Primary Safety Outcome
All-cause mortality at 90 days
|
14 Participants
|
PRIMARY outcome
Timeframe: IntraproceduralPopulation: Per-Protocol
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater within 3 passes of Millipede System without additional therapy, and where use of any additional therapy after achieving mTICI ≥b with the Millipede System is defined as failure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Outcome measures
| Measure |
Millipede System
n=142 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Supplementary Analysis of Primary Effectiveness Endpoint
|
107 Participants
|
SECONDARY outcome
Timeframe: 90 days post-procedurePopulation: Intent-to-Treat: Subjects with completed mRS assessments
The proportion of patients achieving modified Rankin Scale (mRS) score ≤2, evaluated by certified assessors. The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.
Outcome measures
| Measure |
Millipede System
n=177 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Rate of Functional Independence
|
93 Participants
|
SECONDARY outcome
Timeframe: 90 days post-procedurePopulation: Intent-to-Treat
Proportion of subjects that died within 90 days of the procedure
Outcome measures
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Rate of All-Cause Mortality
|
25 Participants
|
SECONDARY outcome
Timeframe: 24-hours post-procedurePopulation: Intent-To-Treat: Imaging available for Core Lab and Clinical Events Committee adjudication
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the Core Lab and Clinical Events Committee
Outcome measures
| Measure |
Millipede System
n=177 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 hours post-procedurePopulation: Intent-To-Treat: Imaging available for Core Lab adjudication
Proportion of subjects with any ICH at 24 hours, as adjudicated by the Core Lab
Outcome measures
| Measure |
Millipede System
n=177 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)
|
55 Participants
|
SECONDARY outcome
Timeframe: 90 days post-procedurePopulation: Intent-to-Treat
Proportion of subjects experiencing one or more SADEs within 90 days post-procedure, as adjudicated by an independent Clinical Events Committee
Outcome measures
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)
|
6 Participants
|
SECONDARY outcome
Timeframe: 90 days post-procedurePopulation: Intent-to-Treat
Proportion of subjects experiencing one or more procedure-related serious adverse events within 90 days post-procedure, as adjudicated by an independent Clinical Events Committee
Outcome measures
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Rate of Procedure-Related Serious Adverse Events (PRSAEs)
|
19 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Intent-to-Treat
Proportion of subjects with distal emboli on final angiography, as adjudicated by an independent Core Lab
Outcome measures
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Rate of Embolization to New Territory (ENT)
|
6 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Intent-to-Treat
Proportion of subjects with mTICI ≥2b at the end of the procedure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b at the end of the procedure, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
|
177 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Intent-to-Treat
Proportion of subjects with mTICI ≥2c at the end of the procedure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c at the end of the procedure, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=180 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
|
148 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Intent-To-Treat: Imaging available after the first device pass for Core Lab adjudication
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede System. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=178 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
|
118 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Intent-To-Treat: Imaging available after the first device pass for Core Lab adjudication
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede System. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=178 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
|
94 Participants
|
SECONDARY outcome
Timeframe: 90 days post-procedurePopulation: Per-Protocol: Subjects with completed mRS assessments
The proportion of patients achieving modified Rankin Scale (mRS) score ≤2, evaluated by certified assessors. The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.
Outcome measures
| Measure |
Millipede System
n=140 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Rate of Functional Independence
|
81 Participants
|
SECONDARY outcome
Timeframe: 90 days post-procedurePopulation: Per-Protocol
Proportion of subjects that died within 90 days of the procedure
Outcome measures
| Measure |
Millipede System
n=142 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Rate of All-Cause Mortality
|
14 Participants
|
SECONDARY outcome
Timeframe: 24-hours post-procedurePopulation: Per-Protocol: Imaging available for Core Lab and Clinical Events Committee adjudication
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the Core Lab and Clinical Events Committee
Outcome measures
| Measure |
Millipede System
n=141 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH)
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 hours post-procedurePopulation: Per Protocol: Imaging available for Core Lab adjudication
Proportion of subjects with any ICH at 24 hours, as adjudicated by the Core Lab
Outcome measures
| Measure |
Millipede System
n=141 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Rate of All Intracranial Hemorrhage (ICH)
|
39 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Per-Protocol
Proportion of subjects with distal emboli on final angiography, as adjudicated by an independent Core Lab
Outcome measures
| Measure |
Millipede System
n=142 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Rate of Embolization to New Territory (ENT)
|
5 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Per-Protocol
Proportion of subjects with mTICI ≥2b at the end of the procedure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b at the end of the procedure, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=142 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Proportion of Subjects With Successful Reperfusion at End of the Thrombectomy Procedure
|
140 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Per-Protocol
Proportion of subjects with mTICI ≥2c at the end of the procedure. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c at the end of the procedure, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=142 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at End of the Thrombectomy Procedure
|
118 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Per-Protocol: Imaging available after the first device pass for Core Lab adjudication
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede System. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=140 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede System
|
96 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Per-Protocol: Imaging available after the first device pass for Core Lab adjudication
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede System. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c after the first pass with the Millipede System, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=140 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Proportion of Subjects With Complete or Near Complete Reperfusion at the End of the First Pass With the Millipede System
|
76 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraproceduralPopulation: Intent-to-Treat: Millipede 088 Catheter was used for the first pass and imaging after the first pass is available for adjudication by an independent Core Lab.
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=114 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter
|
76 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraproceduralPopulation: Intent-to-Treat: Millipede 088 Catheter was used for the first pass and imaging after the first pass is available for adjudication by an independent Core Lab.
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=114 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Proportion of Subjects With Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
|
64 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraproceduralPopulation: Intent-to-Treat: Subjects with M1 occlusions in whom the Millipede 088 Catheter was used for the first pass and imaging after the first pass is available for adjudication by an independent Core Lab.
Proportion of subjects with M1 occlusions achieving mTICI ≥2b after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants with M1 occlusions who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=70 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Proportion of Subjects With M1 Occlusions Achieving Successful Reperfusion After the First Pass With the Millipede 088 Catheter
|
56 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraproceduralPopulation: Intent-to-Treat: Subjects with M1 occlusions in whom the Millipede 088 Catheter was used for the first pass and imaging after the first pass is available for adjudication by an independent Core Lab.
Proportion of subjects with M1 occlusions achieving mTICI ≥2c after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants with M1 occlusions who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=70 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
ITT Cohort: Proportion of Subjects With M1 Occlusions Achieving Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
|
51 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraproceduralPopulation: Per-Protocol: Millipede 088 Catheter was used for the first pass and imaging after the first pass is available for adjudication by an independent Core Lab.
Proportion of subjects with mTICI ≥2b after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=88 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Proportion of Subjects With Successful Reperfusion After the First Pass With the Millipede 088 Catheter
|
62 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraproceduralPopulation: Per-Protocol: Millipede 088 Catheter was used for the first pass and imaging after the first pass is available for adjudication by an independent Core Lab.
Proportion of subjects with mTICI ≥2c after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=88 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Proportion of Subjects With Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
|
53 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraproceduralPopulation: Per-Protocol: Subjects with M1 occlusions in whom the Millipede 088 Catheter was used for the first pass and imaging after the first pass is available for adjudication by an independent Core Lab.
Proportion of subjects with M1 occlusions achieving mTICI ≥2b after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants with M1 occlusions who achieved mTICI ≥2b after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=56 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Proportion of Subjects With M1 Occlusions Achieving Successful Reperfusion After the First Pass With the Millipede 088 Catheter
|
46 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraproceduralPopulation: Per-Protocol: Subjects with M1 occlusions in whom the Millipede 088 Catheter was used for the first pass and imaging after the first pass is available for adjudication by an independent Core Lab.
Proportion of subjects with M1 occlusions achieving mTICI ≥2c after the first pass with the Millipede 088 Catheter. The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants with M1 occlusions who achieved mTICI ≥2c after the first pass with the Millipede 088 Catheter, as adjudicated by an independent Core Lab.
Outcome measures
| Measure |
Millipede System
n=56 Participants
Aspiration thrombectomy using Millipede System
|
|---|---|
|
PP Cohort: Proportion of Subjects With M1 Occlusions Achieving Near Complete or Complete Reperfusion After the First Pass With the Millipede 088 Catheter
|
42 Participants
|
Adverse Events
Millipede System
Serious adverse events
| Measure |
Millipede System
n=180 participants at risk
Aspiration thrombectomy using Millipede System
|
|---|---|
|
Renal and urinary disorders
Renal failure
|
1.1%
2/180 • Intraprocedural to 90 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
3/180 • Intraprocedural to 90 days post-procedure
|
|
Surgical and medical procedures
Dialysis
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Vascular disorders
Hypotension
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Vascular disorders
Hypovolaemic shock
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
2/180 • Intraprocedural to 90 days post-procedure
|
|
Cardiac disorders
Angina pectoris
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Cardiac disorders
Cardiac arrest
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Cardiac disorders
Cardiac failure
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Cardiac disorders
Cardiac failure congestive
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Cardiac disorders
Left ventricular failure
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
4/180 • Intraprocedural to 90 days post-procedure
|
|
Cardiac disorders
Tachycardia
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
2/180 • Intraprocedural to 90 days post-procedure
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
General disorders
General physical health deterioration
|
1.1%
2/180 • Intraprocedural to 90 days post-procedure
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
General disorders
Vascular stent occlusion
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Infections and infestations
Endocarditis
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Infections and infestations
Enterocolitis infectious
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Infections and infestations
Pneumonia
|
2.8%
5/180 • Intraprocedural to 90 days post-procedure
|
|
Infections and infestations
Sepsis
|
1.7%
3/180 • Intraprocedural to 90 days post-procedure
|
|
Infections and infestations
Septic shock
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Infections and infestations
Urinary tract infection
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Brain oedema
|
1.7%
3/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Carotid artery occlusion
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Cerebral artery embolism
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Cerebral infarction
|
1.7%
3/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Cerebral mass effect
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.1%
2/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
1.1%
2/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Intracranial artery dissection
|
1.1%
2/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Ischaemic stroke
|
3.9%
7/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Neurological decompensation
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Stroke in evolution
|
2.8%
5/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Syncope
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
|
Psychiatric disorders
Confusional state
|
0.56%
1/180 • Intraprocedural to 90 days post-procedure
|
Other adverse events
| Measure |
Millipede System
n=180 participants at risk
Aspiration thrombectomy using Millipede System
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
7/180 • Intraprocedural to 90 days post-procedure
|
|
Infections and infestations
Pneumonia
|
7.2%
13/180 • Intraprocedural to 90 days post-procedure
|
|
Infections and infestations
Urinary tract infection
|
4.4%
8/180 • Intraprocedural to 90 days post-procedure
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
3.9%
7/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Brain oedema
|
3.3%
6/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Haemorrhage intracranial
|
3.3%
6/180 • Intraprocedural to 90 days post-procedure
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
25.0%
45/180 • Intraprocedural to 90 days post-procedure
|
|
Renal and urinary disorders
Urinary retention
|
3.9%
7/180 • Intraprocedural to 90 days post-procedure
|
|
Vascular disorders
Hypotension
|
3.3%
6/180 • Intraprocedural to 90 days post-procedure
|
|
Vascular disorders
Vasospasm
|
3.3%
6/180 • Intraprocedural to 90 days post-procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60