Intracranial Aneurysm, Subarachnoid Hemorrhage
Conditions
Keywords
large aneurysm, recurrence, hydrocoil
Brief summary
The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years. The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET study is that the newer hydrocoil will be more effective and yet as safe as the older platinum coil.
Interventions
PROCEDUREendovascular coil embolization
standard endovascular coil embolization with or without adjunct techniques
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients presenting at least one aneurysm 'prone to recurrence after endovascular treatment' (PRET), defined for the sake of this study as: * PRET-1: One ruptured or unruptured aneurysm, never treated, with a dimension ≥10mm (longest axis, including thrombosed portions of large or giant aneurysms); for ruptured lesions, patients should be in WFNS grade I, II or III. * PRET-2: an Aneurysm presenting a major recurrence after previous coiling; and judged by the neurovascular team to require elective treatment. * The anatomy of the lesion is such that endovascular treatment is possible with both types of coils (not necessarily certain or probable) * The endovascular physician is content to use either type of coils (platinum or hydrogel-coated coils) but no other type of coils * Patient is 18 or older * Life expectancy is more than 2 years
Exclusion criteria
* Presence of other aneurysms requiring treatment during the same session * Patients with associated cerebral arteriovenous malformations * When parent vessel occlusion, without simultaneous endosaccular coiling of the aneurysm, is the primary intent of the procedure * Any absolute contraindication to endovascular treatment, angiography, or anaesthesia such as severe allergies to contrast or medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate of Target Aneurysm. | 18 months | 1. major angiographic recurrence of the lesion or the presence of a residual aneurysm at last angiographic follow-up, as determined by the core laboratory, blinded to treatment allocation; 2. retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 3. an intracranial bleeding episode, or the occurrence or progression of a mass effect in relation to the treated aneurysm during the follow-up period, as determined by the blinded Adverse Event Committee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | 18 months | Number of participants dead - All causes |
| Number of Participants With Adverse Events | 18 months | Number of participants having experienced one or several Adverse Events. This measure is the number of participants having experienced Serious Adverse Events plus those having experienced other (not including Serious) Adverse Events. |
| Number of Participants With Serious Adverse Events | 18 months | Number of participants having experienced one or several Serious Adverse Events |
Countries
Canada, Chile, France, Japan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platinum Coils Endovascular coil embolization with standard platinum coils
endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques | 222 |
| Hydrogel Coils Endovascular coil embolization with hydrogel coils
endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques | 225 |
| Total | 447 |
Baseline characteristics
| Characteristic | Platinum Coils | Hydrogel Coils | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 12 | 57 years STANDARD_DEVIATION 11 | 58 years STANDARD_DEVIATION 11 |
| Aneurysm size (mean (SD)) | 11.3 millimeters STANDARD_DEVIATION 5.8 | 10.7 millimeters STANDARD_DEVIATION 5.3 | 11.0 millimeters STANDARD_DEVIATION 5.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 75 Participants | 61 Participants | 136 Participants |
| Region of Enrollment Chile | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment France | 15 Participants | 18 Participants | 33 Participants |
| Region of Enrollment Japan | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United Kingdom | 10 Participants | 12 Participants | 22 Participants |
| Region of Enrollment United States | 112 Participants | 126 Participants | 238 Participants |
| Ruptured aneurysms (Number) | 39 Participants | 40 Participants | 79 Participants |
| Sex: Female, Male Female | 154 Participants | 165 Participants | 319 Participants |
| Sex: Female, Male Male | 68 Participants | 60 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 222 | 13 / 222 |
| other Total, other adverse events | 17 / 222 | 16 / 222 |
| serious Total, serious adverse events | 20 / 222 | 25 / 222 |
Outcome results
Primary
Recurrence Rate of Target Aneurysm.
1. major angiographic recurrence of the lesion or the presence of a residual aneurysm at last angiographic follow-up, as determined by the core laboratory, blinded to treatment allocation; 2. retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 3. an intracranial bleeding episode, or the occurrence or progression of a mass effect in relation to the treated aneurysm during the follow-up period, as determined by the blinded Adverse Event Committee.
Time frame: 18 months
Population: For the Platinum coils population (222):~Primary outcome available for 220/222 (could not attribute primary outcome for 2 participants)~For the Hydrogel coils population (225):~Withdrawn by physician right after Registration: 3/225 (remaining 222) Primary outcome available for 215/222 (could not attribute primary outcome for 7 participants)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platinum Coils | Recurrence Rate of Target Aneurysm. | 102 Participants |
| Hydrogel Coils | Recurrence Rate of Target Aneurysm. | 103 Participants |
Secondary
Mortality Rate
Number of participants dead - All causes
Time frame: 18 months
Population: For the Platinum coils population (222):~Secondary outcome measure applies to 222 participants.~For the Hydrogel coils population (225):~Withdrawn by physician right after Registration: 3/225 (remaining 222). Secondary outcome measure applies to 222 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platinum Coils | Mortality Rate | 3 Participants |
| Hydrogel Coils | Mortality Rate | 13 Participants |
Secondary
Number of Participants With Adverse Events
Number of participants having experienced one or several Adverse Events. This measure is the number of participants having experienced Serious Adverse Events plus those having experienced other (not including Serious) Adverse Events.
Time frame: 18 months
Population: For the Platinum coils population (222):~Secondary outcome measure applies to 222 participants.~For the Hydrogel coils population (225):~Withdrawn by physician right after Registration: 3/225 (remaining 222). Secondary outcome measure applies to 222 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platinum Coils | Number of Participants With Adverse Events | 37 Participants |
| Hydrogel Coils | Number of Participants With Adverse Events | 41 Participants |
Secondary
Number of Participants With Serious Adverse Events
Number of participants having experienced one or several Serious Adverse Events
Time frame: 18 months
Population: For the Platinum coils population (222):~Secondary outcome measure applies to 222 participants.~For the Hydrogel coils population (225):~Withdrawn by physician right after Registration: 3/225 (remaining 222). Secondary outcome measure applies to 222 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platinum Coils | Number of Participants With Serious Adverse Events | 20 Participants |
| Hydrogel Coils | Number of Participants With Serious Adverse Events | 25 Participants |