Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | platinum coils |
|
| 2 | Active Comparator | hydrogel coils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular coil embolization | Procedure | standard endovascular coil embolization with or without adjunct techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rate of Target Aneurysm. |
| 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | Number of participants dead - All causes | 18 months |
| 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. |
Not provided
Inclusion Criteria:
All patients presenting at least one aneurysm 'prone to recurrence after endovascular treatment' (PRET), defined for the sake of this study as:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean RAYMOND, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Study Chair |
| Daniel ROY, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands - University of Florida Hospital | Gainesville | Florida | United States | |||
| Borgess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24849854 | Derived | Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Platinum Coils | Endovascular coil embolization with standard platinum coils |
| FG001 | Hydrogel Coils | Endovascular Coil embolization with Hydrogel Coils |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 18 months |
| Number of Participants With Serious Adverse Events | Number of participants having experienced one or several Serious Adverse Events | 18 months |
| Kalamazoo |
| Michigan |
| United States |
| Mayo Clinic Rochester | Rochester | Minnesota | United States |
| University of Mississipi Health Care | Jackson | Mississippi | 39216 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | United States |
| Washington University in St Louis | St Louis | Missouri | United States |
| University of Buffalo (SUNY) | Buffalo | New York | United States |
| Stony Brook University Medical Center (SUNY) | Stony Brook | New York | United States |
| SUNY Upstate Medical University | Syracuse | New York | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | United States |
| Cleveland Clinic | Cleveland | Ohio | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States |
| Oregon Health and Science University | Portland | Oregon | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| The Methodist Hospital | Houston | Texas | United States |
| University of Virginia Health System | Charlottesville | Virginia | United States |
| West Virginia University Hospital | Morgantown | West Virginia | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States |
| University of Alberta Hospital | Edmonton | Alberta | Canada |
| The Ottawa Hospital | Ottawa | Ontario | Canada |
| Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital | Montreal | Quebec | H2L 4M1 | Canada |
| Instituto de Neurocirugía Dr. Asenjo | Santiago | Chile |
| CHU Bordeaux - Hôpital Pellegrin | Bordeaux | France |
| CHU Henri Mondor - Hôpital Henri Mondor | Créteil | France |
| CHU de Montpellier - Hôpital Gui de Chauliac | Montpellier | France |
| CHU Nancy-Hôpital Central | Nancy | France |
| CHU de Nantes - Hôpital Guillaume et René Laennec | Nantes | France |
| Centre Hospitalier Sainte Anne | Paris | France |
| Kobe City Medical Center General Hospital | Kobe | Japan |
| Leeds General Infirmary | Leeds | United Kingdom |
| The Walton Centre NHS Foundation Trust | Liverpool | United Kingdom |
| Queens Medical Centre | Nottingham | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Platinum Coils | Endovascular coil embolization with standard platinum coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques |
| BG001 | Hydrogel Coils | Endovascular coil embolization with hydrogel coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Ruptured aneurysms (Number) | Count of Participants | Participants |
| ||||||||||||||||
| Aneurysm size (mean (SD)) | Mean | Standard Deviation | millimeters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrence Rate of Target Aneurysm. |
| 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) | Posted | Count of Participants | Participants | 18 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Mortality Rate | Number of participants dead - All causes | 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 | Posted | Count of Participants | Participants | 18 months |
|
| ||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Count of Participants | Participants | 18 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events | Number of participants having experienced one or several Serious Adverse Events | 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 | Posted | Count of Participants | Participants | 18 months |
|
|
18 months
an Adverse Event is defined as an event of any severity being possibly or probably related to the disease or the treatment and happening at any time during the 18-month follow-up period. The independent Adverse Event Committee was responsible for the attribution of Adverse Events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Platinum Coils | platinum coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques | 3 | 222 | 20 | 222 | 17 | 222 |
| EG001 | Hydrogel Coils | hydrogel coils endovascular coil embolization: standard endovascular coil embolization with or without adjunct techniques | 13 | 222 | 25 | 222 | 16 | 222 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sub-arachnoid hemorrhage | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Mass Effect | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| stroke | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| subdural hematoma | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| non neurologic | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Retreatment related | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
| |
| periprocedure event | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Ischemic Attack | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Mass Effect | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Inflammatory | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Non neurologic | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Retreatment related | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
| |
| Periprocedure event | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
Operators could not be blinded to coil type. This may have affected case selection, coil selection, and completeness of the coiling procedure. Aneurysm volumes were not directly measured but extrapolated from aneurysm dimensions.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruby Klink, coordinator | Centre de Recherches du Centre Hospitalier de l'Université de Montréal | (514) 890 8000 | 25245 | ruby.klink@crchum.qc.ca |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D013345 | Subarachnoid Hemorrhage |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
Not provided
Not provided
|
|
|
| United States |
|
|
| Japan |
|
|
| United Kingdom |
|
|
| France |
|
|
| Chile |
|
|
|
|
|
|
|