Intracranial AneurysmPhase 4PRETNCT00626912
PRET: Patients Prone to Recurrence After Endovascular Treatment
A Phase 4 study testing endovascular coil embolization in people with Intracranial Aneurysm and Subarachnoid Hemorrhage, run by Centre hospitalier de l'Université de Montréal (CHUM) at 32 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm, Subarachnoid Hemorrhage
- What is being tested?
- endovascular coil embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 32 sitesin 6 countries
- Study dates
- Jun 2007to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
United States18 sites
University of Buffalo (SUNY)
Buffalo, New York
Saint Francis Medical Center
Cape Girardeau, Missouri
Medical University of South Carolina
Charleston, South Carolina
University of Virginia Health System
Charlottesville, Virginia
University of Cincinnati Medical Center
Cincinnati, Ohio
Cleveland Clinic
Cleveland, Ohio
Shands - University of Florida Hospital
Gainesville, Florida
The Methodist Hospital
Houston, Texas
University of Mississipi Health Care
Jackson, Mississippi, 39216
Borgess Medical Center
Kalamazoo, Michigan
University of Wisconsin Hospital and Clinics
Madison, Wisconsin
West Virginia University Hospital
Morgantown, West Virginia
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
Oregon Health and Science University
Portland, Oregon
Mayo Clinic Rochester
Rochester, Minnesota
Washington University in St Louis
St Louis, Missouri
Stony Brook University Medical Center (SUNY)
Stony Brook, New York
SUNY Upstate Medical University
Syracuse, New York
France6 sites
CHU Bordeaux - Hôpital Pellegrin
Bordeaux
CHU Henri Mondor - Hôpital Henri Mondor
Créteil
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier
CHU Nancy-Hôpital Central
Nancy
CHU de Nantes - Hôpital Guillaume et René Laennec
Nantes
Centre Hospitalier Sainte Anne
Paris
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta
Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital
Montreal, Quebec, H2L 4M1
The Ottawa Hospital
Ottawa, Ontario
United Kingdom3 sites
Leeds General Infirmary
Leeds
The Walton Centre NHS Foundation Trust
Liverpool
Queens Medical Centre
Nottingham
About this study
Official title: PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils
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.
- Conditions
- Intracranial Aneurysm, Subarachnoid Hemorrhage
- Being tested
- endovascular coil embolization
- Keywords
- large aneurysm, recurrence, hydrocoil
- Medical subject headings
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular coil embolizationProcedure or surgery
Also called platinum coil, hydrogel coil
standard endovascular coil embolization with or without adjunct techniques
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | platinum coils Receives: Procedure: endovascular coil embolization |
| 2 | Active comparator | hydrogel coils Receives: Procedure: endovascular coil embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate of Target Aneurysm.
- 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;
- retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period;
- 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.
Measured: 18 months
Secondary outcomes (3)
Mortality Rate
Number of participants dead - All causes
Measured: 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.
Measured: 18 months
Number of Participants With Serious Adverse Events
Number of participants having experienced one or several Serious Adverse Events
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJun 2007
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean RAYMOND, MD, Study chair, Centre hospitalier de l'Université de Montréal (CHUM)Daniel ROY, MD, Study director, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626912
- Sponsor's protocol ID
- ND07.001
- Acronym
- PRET
- Status last verified
- Jul 2016
- First submitted
- 21 Feb 2008
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24849854
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils
- ClinicalTrials.gov ID
- NCT00626912
- Acronym / sponsor ID
- PRET / ND07.001
- Conditions
- Intracranial Aneurysm, Subarachnoid Hemorrhage
- Keywords
- large aneurysm, recurrence, hydrocoil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 1 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: endovascular coil embolizationplatinum coils |
| 2 | Active comparator | Procedure: endovascular coil embolizationhydrogel coils |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular coil embolizationAlso: platinum coil, hydrogel coilstandard endovascular coil embolization with or without adjunct techniques | Procedure or surgery | 1, 2 |
Primary outcome
Recurrence Rate of Target Aneurysm.
Time frame: 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.
3 secondary outcomes
Mortality Rate
Time frame: 18 months
Number of Participants With Adverse Events
Time frame: 18 months
Number of Participants With Serious Adverse Events
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24849854Naggara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean RAYMOND, MD study chair
Centre hospitalier de l'Université de Montréal (CHUM)
Daniel ROY, MD study director
Centre hospitalier de l'Université de Montréal (CHUM)
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing endovascular coil embolization in people with Intracranial Aneurysm and Subarachnoid Hemorrhage, run by Centre hospitalier de l'Université de Montréal (CHUM) at 32 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, France, Canada, United Kingdom, Chile and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Rate of Target Aneurysm. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00626912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.