Trial Outcomes & Findings for A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients (NCT NCT04089917)
NCT ID: NCT04089917
Last Updated: 2023-09-07
Results Overview
Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel
Recruitment status
COMPLETED
Target enrollment
45 participants
Primary outcome timeframe
intra-procedural
Results posted on
2023-09-07
Participant Flow
Participant milestones
| Measure |
Q Aspiration Catheter
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Q Aspiration Catheter
n=45 Participants
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=45 Participants
|
|
Region of Enrollment
Spain
|
45 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: intra-proceduralDefined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel
Outcome measures
| Measure |
Q Aspiration Catheter
n=45 Participants
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
|
|---|---|
|
Successful Revascularization Rate
|
42 Participants
|
PRIMARY outcome
Timeframe: 24 hours post procedureDefined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of \>/= 4 points
Outcome measures
| Measure |
Q Aspiration Catheter
n=45 Participants
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
|
|---|---|
|
Symptomatic Intracranial Haemorrhage Rate
|
1 Participants
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SECONDARY outcome
Timeframe: intra-proceduralDefined as mTICI 2b-3 flow in the target vessel post-treatment with the Q Catheter (first line therapy)
Outcome measures
| Measure |
Q Aspiration Catheter
n=38 Participants
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
|
|---|---|
|
Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device
|
25 Participants
|
SECONDARY outcome
Timeframe: intra-proceduralAs measured by independent Angiographic Core Lab
Outcome measures
| Measure |
Q Aspiration Catheter
n=45 Participants
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
|
|---|---|
|
Rate of Embolization to a New Neurovascular Territory (ENT)
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 daysThe Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).
Outcome measures
| Measure |
Q Aspiration Catheter
n=45 Participants
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
|
|---|---|
|
Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2
|
25 Participants
|
SECONDARY outcome
Timeframe: 90 daysRate of all cause mortality
Outcome measures
| Measure |
Q Aspiration Catheter
n=45 Participants
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
|
|---|---|
|
Mortality Rate
|
7 Participants
|
Adverse Events
Q Aspiration Catheter
Serious events: 11 serious events
Other events: 6 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Q Aspiration Catheter
n=45 participants at risk
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
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|---|---|
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General disorders
Hemorrhagic transformation
|
13.3%
6/45 • Number of events 6 • From procedure through subject 3 month follow up visit, serious adverse events were collected
|
|
General disorders
Death of unknown cause
|
8.9%
4/45 • Number of events 4 • From procedure through subject 3 month follow up visit, serious adverse events were collected
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
1/45 • Number of events 1 • From procedure through subject 3 month follow up visit, serious adverse events were collected
|
|
Respiratory, thoracic and mediastinal disorders
mechanical ventilation complications
|
4.4%
2/45 • Number of events 2 • From procedure through subject 3 month follow up visit, serious adverse events were collected
|
Other adverse events
| Measure |
Q Aspiration Catheter
n=45 participants at risk
mechanical thrombectomy for acute ischemic stroke
Q Aspiration Catheter: The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
|
|---|---|
|
Injury, poisoning and procedural complications
procedural complication
|
13.3%
6/45 • Number of events 6 • From procedure through subject 3 month follow up visit, serious adverse events were collected
|
Additional Information
Mariano Espinosa de Rueda
Department of Interventional Neuroradiology, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain
Phone: +34 968 36 96 42
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place