Trial Outcomes & Findings for Endovascular Recanalization and Standard Medical Management for Symptomatic Nonacute Intracranial Artery Occlusion Trial (NCT NCT04864691)
NCT ID: NCT04864691
Last Updated: 2025-02-18
Results Overview
The primary outcome was a composite of any stroke or death within 30 days after enrollment or ischemic stroke in the territory of the qualifying artery from 30 days to 1 year after enrollment.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
453 participants
Primary outcome timeframe
One year
Results posted on
2025-02-18
Participant Flow
Participant milestones
| Measure |
Endovascular Recanalization Plus Standard Medical Treatment
patients with symptomatic non-acute intracranial artery occlusion treated by endovascular recanalization and standard medical treatment after procedure
endovascular recanalization: to recanalize the occlusion cerebral artery with intravascular intervention
|
Standard Medical Treatment
Patients take aspirin 100 mg/day or clopidogrel 75mg/day for the entire follow-up period (EVR patients take aspirin 100 mg/day and clopidogrel 75mg/day for 30-90 days after procedure)
endovascular recanalization: to recanalize the occlusion cerebral artery with intravascular intervention
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
299
|
|
Overall Study
COMPLETED
|
148
|
288
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
17 patients lost to 1 year follow-up
Baseline characteristics by cohort
| Measure |
Endovascular Recanalization Plus Standard Medical Treatment
n=154 Participants
patients with symptomatic non-acute intracranial artery occlusion treated by endovascular recanalization and standard medical treatment after procedure
endovascular recanalization: to recanalize the occlusion cerebral artery with intravascular intervention
|
Standard Medical Treatment
n=299 Participants
Patients take aspirin 100 mg/day or clopidogrel 75mg/day for the entire follow-up period (EVR patients take aspirin 100 mg/day and clopidogrel 75mg/day for 30-90 days after procedure)
endovascular recanalization: to recanalize the occlusion cerebral artery with intravascular intervention
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=148 Participants • 17 patients lost to 1 year follow-up
|
0 Participants
n=288 Participants • 17 patients lost to 1 year follow-up
|
0 Participants
n=436 Participants • 17 patients lost to 1 year follow-up
|
|
Age, Categorical
Between 18 and 65 years
|
113 Participants
n=148 Participants • 17 patients lost to 1 year follow-up
|
207 Participants
n=288 Participants • 17 patients lost to 1 year follow-up
|
320 Participants
n=436 Participants • 17 patients lost to 1 year follow-up
|
|
Age, Categorical
>=65 years
|
35 Participants
n=148 Participants • 17 patients lost to 1 year follow-up
|
81 Participants
n=288 Participants • 17 patients lost to 1 year follow-up
|
116 Participants
n=436 Participants • 17 patients lost to 1 year follow-up
|
|
Age, Continuous
|
57 years
n=148 Participants • 17 patients lost to 1 year follow-up
|
58 years
n=288 Participants • 17 patients lost to 1 year follow-up
|
57 years
n=436 Participants • 17 patients lost to 1 year follow-up
|
|
Sex: Female, Male
Female
|
42 Participants
n=148 Participants • 17 patients lost to 1 year follow-up
|
72 Participants
n=288 Participants • 17 patients lost to 1 year follow-up
|
114 Participants
n=436 Participants • 17 patients lost to 1 year follow-up
|
|
Sex: Female, Male
Male
|
106 Participants
n=148 Participants • 17 patients lost to 1 year follow-up
|
216 Participants
n=288 Participants • 17 patients lost to 1 year follow-up
|
322 Participants
n=436 Participants • 17 patients lost to 1 year follow-up
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=154 Participants
|
0 Participants
n=299 Participants
|
0 Participants
n=453 Participants
|
|
Race (NIH/OMB)
Asian
|
154 Participants
n=154 Participants
|
299 Participants
n=299 Participants
|
453 Participants
n=453 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=154 Participants
|
0 Participants
n=299 Participants
|
0 Participants
n=453 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=154 Participants
|
0 Participants
n=299 Participants
|
0 Participants
n=453 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=154 Participants
|
0 Participants
n=299 Participants
|
0 Participants
n=453 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=154 Participants
|
0 Participants
n=299 Participants
|
0 Participants
n=453 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=154 Participants
|
0 Participants
n=299 Participants
|
0 Participants
n=453 Participants
|
PRIMARY outcome
Timeframe: One yearThe primary outcome was a composite of any stroke or death within 30 days after enrollment or ischemic stroke in the territory of the qualifying artery from 30 days to 1 year after enrollment.
Outcome measures
| Measure |
Endovascular Recanalization Plus Standard Medical Treatment
n=148 Participants
patients with symptomatic non-acute intracranial artery occlusion treated by endovascular recanalization and standard medical treatment after procedure
endovascular recanalization: to recanalize the occlusion cerebral artery with intravascular intervention
|
Standard Medical Treatment
n=288 Participants
Patients take aspirin 100 mg/day or clopidogrel 75mg/day for the entire follow-up period (EVR patients take aspirin 100 mg/day and clopidogrel 75mg/day for 30-90 days after procedure)
endovascular recanalization: to recanalize the occlusion cerebral artery with intravascular intervention
|
|---|---|---|
|
Primary Outcome
|
27 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: within 30 days and 90 days in both groupsstroke/ TIA ipsilateral to the target vessel will be defined according to the World
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: t 30 days, 90 days, 8 months, 12 months and 24 months for both groupsto evaluate the change in all-cause mortality, mRS score, NIHSS score and cognitive function in the two groups
Outcome measures
Outcome data not reported
Adverse Events
Endovascular Recanalization Plus Standard Medical Treatment
Serious events: 9 serious events
Other events: 0 other events
Deaths: 7 deaths
Standard Medical Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Endovascular Recanalization Plus Standard Medical Treatment
n=148 participants at risk
patients with symptomatic non-acute intracranial artery occlusion treated by endovascular recanalization and standard medical treatment after procedure
endovascular recanalization: to recanalize the occlusion cerebral artery with intravascular intervention
|
Standard Medical Treatment
n=288 participants at risk
Patients take aspirin 100 mg/day or clopidogrel 75mg/day for the entire follow-up period (EVR patients take aspirin 100 mg/day and clopidogrel 75mg/day for 30-90 days after procedure)
endovascular recanalization: to recanalize the occlusion cerebral artery with intravascular intervention
|
|---|---|---|
|
Vascular disorders
Serious Adverse Event
|
6.1%
9/148 • 1 year
|
0.00%
0/288 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Feng Gao
Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Phone: 13581936066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place