Trial Outcomes & Findings for Trial on Endovascular Aneurysm Management (NCT NCT00537134)
NCT ID: NCT00537134
Last Updated: 2022-12-30
Results Overview
Morbidity or mortality is evaluated using the modified Rankin Scale (mRS) which goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process. a "Good" Primary Outcome was categorized from mRS scores of 0, 1, or 2. a "Bad" Primary Outcome was categorized from mRS scores of 3, 4, 5 or 6.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
1 year after treatment or observation
Results posted on
2022-12-30
Participant Flow
Participants are recruited when seen in clinic either for neurological symptoms or when aneurysm is an incidental finding
there are no pre-assignment procedures before assignment to groups
Participant milestones
| Measure |
Endovascular
Endovascular treatment by coil embolization
Embolization, coiling: Endovascular embolization with platinum coils
|
Conservative
Conservative management (watchful observation)
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
38
|
|
Overall Study
COMPLETED
|
42
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Conservative
n=38 Participants
Conservative management (watchful observation)
Inclusion criteria:
1. At least one documented subarachnoid aneurysm, never ruptured
2. Patient aged 18 or older
3. Life expectancy more than 10 years
Exclusion crieria:
1. Patients with recent (less than 3 months) intracranial haemorrhage
2. Lesion characteristics unsuitable for endovascular treatment
3. Patients with a single extradural aneurysm
4. Aneurysms \<3mm or giant aneurysms (≥25mm)
5. Patients with a poor outcome (Rankin scale ≥3) after the rupture, surgical or endovascular treatment of another aneurysm
6. Patients with incompletely treated aneurysms that have previously ruptured
7. Patients with associated arteriovenous malformations
8. Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)
9. Patients with previous intracranial haemorrhage from unknown aetiology
10. Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management
11. Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium
12. Pregnant patients
13. Patients unable to give informed consent
|
Endovascular
n=42 Participants
Endovascular treatment
Embolization, coiling: Endovascular embolization with platinum coils
Same population as Conservative management
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=38 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=80 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=38 Participants
|
32 Participants
n=42 Participants
|
63 Participants
n=80 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=38 Participants
|
10 Participants
n=42 Participants
|
17 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=38 Participants
|
25 Participants
n=42 Participants
|
52 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=38 Participants
|
17 Participants
n=42 Participants
|
28 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
11 participants
n=38 Participants
|
20 participants
n=42 Participants
|
31 participants
n=80 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=38 Participants
|
1 participants
n=42 Participants
|
4 participants
n=80 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=38 Participants
|
9 participants
n=42 Participants
|
18 participants
n=80 Participants
|
|
Region of Enrollment
France
|
11 participants
n=38 Participants
|
10 participants
n=42 Participants
|
21 participants
n=80 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=38 Participants
|
2 participants
n=42 Participants
|
6 participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 1 year after treatment or observationMorbidity or mortality is evaluated using the modified Rankin Scale (mRS) which goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process. a "Good" Primary Outcome was categorized from mRS scores of 0, 1, or 2. a "Bad" Primary Outcome was categorized from mRS scores of 3, 4, 5 or 6.
Outcome measures
| Measure |
Conservative
n=12 Participants
Conservative management (watchful observation)
Inclusion criteria:
1. At least one documented subarachnoid aneurysm, never ruptured
2. Patient aged 18 or older
3. Life expectancy more than 10 years
Exclusion crieria:
1. Patients with recent (less than 3 months) intracranial haemorrhage
2. Lesion characteristics unsuitable for endovascular treatment
3. Patients with a single extradural aneurysm
4. Aneurysms \<3mm or giant aneurysms (≥25mm)
5. Patients with a poor outcome (Rankin scale ≥3) after the rupture, surgical or endovascular treatment of another aneurysm
6. Patients with incompletely treated aneurysms that have previously ruptured
7. Patients with associated arteriovenous malformations
8. Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)
9. Patients with previous intracranial haemorrhage from unknown aetiology
10. Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management
11. Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium
12. Pregnant patients
13. Patients unable to give informed consent
|
Endovascular
n=11 Participants
Endovascular treatment
Embolization, coiling: Endovascular embolization with platinum coils
Same population as Conservative management
|
|---|---|---|
|
Number of Participants With Disease or Treatment-related Morbidity and Mortality.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 5 and 10 yearsPopulation: No patients available for outcome measure at 5 years because study was terminated
To better define the natural history of unruptured aneurysms eligible for endovascular treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 yearNumber of participants experiencing a hemorrhagic event despite successful treatment. This outcome measure gives an estimate of risk of rupture despite treatment
Outcome measures
| Measure |
Conservative
n=12 Participants
Conservative management (watchful observation)
Inclusion criteria:
1. At least one documented subarachnoid aneurysm, never ruptured
2. Patient aged 18 or older
3. Life expectancy more than 10 years
Exclusion crieria:
1. Patients with recent (less than 3 months) intracranial haemorrhage
2. Lesion characteristics unsuitable for endovascular treatment
3. Patients with a single extradural aneurysm
4. Aneurysms \<3mm or giant aneurysms (≥25mm)
5. Patients with a poor outcome (Rankin scale ≥3) after the rupture, surgical or endovascular treatment of another aneurysm
6. Patients with incompletely treated aneurysms that have previously ruptured
7. Patients with associated arteriovenous malformations
8. Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)
9. Patients with previous intracranial haemorrhage from unknown aetiology
10. Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management
11. Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium
12. Pregnant patients
13. Patients unable to give informed consent
|
Endovascular
n=12 Participants
Endovascular treatment
Embolization, coiling: Endovascular embolization with platinum coils
Same population as Conservative management
|
|---|---|---|
|
Number of Participants With Hemorrhage in Endovascular Group
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 1 yearThe modified Rankin Scale (mRS) goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process. The number of participants having in each score is given.
Outcome measures
| Measure |
Conservative
n=12 Participants
Conservative management (watchful observation)
Inclusion criteria:
1. At least one documented subarachnoid aneurysm, never ruptured
2. Patient aged 18 or older
3. Life expectancy more than 10 years
Exclusion crieria:
1. Patients with recent (less than 3 months) intracranial haemorrhage
2. Lesion characteristics unsuitable for endovascular treatment
3. Patients with a single extradural aneurysm
4. Aneurysms \<3mm or giant aneurysms (≥25mm)
5. Patients with a poor outcome (Rankin scale ≥3) after the rupture, surgical or endovascular treatment of another aneurysm
6. Patients with incompletely treated aneurysms that have previously ruptured
7. Patients with associated arteriovenous malformations
8. Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)
9. Patients with previous intracranial haemorrhage from unknown aetiology
10. Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management
11. Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium
12. Pregnant patients
13. Patients unable to give informed consent
|
Endovascular
n=11 Participants
Endovascular treatment
Embolization, coiling: Endovascular embolization with platinum coils
Same population as Conservative management
|
|---|---|---|
|
Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group
mRS is 0
|
10 Participants
|
8 Participants
|
|
Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group
mRS is 1
|
2 Participants
|
2 Participants
|
|
Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group
mRS is 2
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 10 yearsPopulation: No patients available for outcome measure at 10 years because study was terminated
To compare overall Morbidity/Mortality of the 2 groups
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 5 and 10 yearsPopulation: No patients available for outcome measure at 5 and 10 years because study was terminated
To compare the quality of life and anxiety levels of surviving patients of the 2 groups according to the SF-36 questionnaire minimum is 0 (maximum disability) maximum is 100 (No disability)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 5 and 10 yearsPopulation: No patients available for outcome measure at 5 years because study was terminated
To determine the rate of occlusion of aneurysms treated by coiling in an effort to estimate longer-term efficacy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 5 and 10 yearsPopulation: No patients available for outcome measure at 5 years because study was terminated
To determine the rate of aneurysmal growth in the conservative group in surviving patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1 year, 5 and 10 yearsPopulation: Patients with MoCa scores at Baseline and 1 year
To verify cognitive functions using the MoCA in all patients before and 6 months after treatment in a consecutive sample of 100 patients of both groups. Minimum value on the MoCA is 0 (maximum cognitive decline) Maximum value on the MoCA is 30 (no cognitive decline) A score higher than 26 was categorized as "good" cognitive condition A score of 26 or lower was categorized as "bad" cognitive conditionn
Outcome measures
| Measure |
Conservative
n=11 Participants
Conservative management (watchful observation)
Inclusion criteria:
1. At least one documented subarachnoid aneurysm, never ruptured
2. Patient aged 18 or older
3. Life expectancy more than 10 years
Exclusion crieria:
1. Patients with recent (less than 3 months) intracranial haemorrhage
2. Lesion characteristics unsuitable for endovascular treatment
3. Patients with a single extradural aneurysm
4. Aneurysms \<3mm or giant aneurysms (≥25mm)
5. Patients with a poor outcome (Rankin scale ≥3) after the rupture, surgical or endovascular treatment of another aneurysm
6. Patients with incompletely treated aneurysms that have previously ruptured
7. Patients with associated arteriovenous malformations
8. Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)
9. Patients with previous intracranial haemorrhage from unknown aetiology
10. Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management
11. Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium
12. Pregnant patients
13. Patients unable to give informed consent
|
Endovascular
n=9 Participants
Endovascular treatment
Embolization, coiling: Endovascular embolization with platinum coils
Same population as Conservative management
|
|---|---|---|
|
Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)
Baseline · Score is 26 or lower
|
1 Participants
|
4 Participants
|
|
Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)
Baseline · Score is higher than 26
|
10 Participants
|
5 Participants
|
|
Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)
1 year · Score is 26 or lower
|
3 Participants
|
2 Participants
|
|
Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)
1 year · Score is higher than 26
|
8 Participants
|
7 Participants
|
Adverse Events
Conservative
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Endovascular
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conservative
n=38 participants at risk
Conservative management (watchful observation)
|
Endovascular
n=42 participants at risk
Endovascular treatment
Embolization, coiling: Endovascular embolization with platinum coils
|
|---|---|---|
|
Vascular disorders
Hemorrhage
|
0.00%
0/38 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
2.4%
1/42 • Number of events 1 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
Other adverse events
| Measure |
Conservative
n=38 participants at risk
Conservative management (watchful observation)
|
Endovascular
n=42 participants at risk
Endovascular treatment
Embolization, coiling: Endovascular embolization with platinum coils
|
|---|---|---|
|
Psychiatric disorders
Depression
|
2.6%
1/38 • Number of events 1 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
0.00%
0/42 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
|
General disorders
Migraine
|
2.6%
1/38 • Number of events 1 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
2.4%
1/42 • Number of events 1 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/38 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
2.4%
1/42 • Number of events 1 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
|
Surgical and medical procedures
arm hematoma
|
0.00%
0/38 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
2.4%
1/42 • Number of events 1 • The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
|
Additional Information
Ruby Klink
Centre Hospitalier de l'Université de Montréal (CHUM)
Phone: (514) 890-8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place