Ruptured Aneurysm of Intracranial ArteryDIVERTNCT01976026
DIVERT: Diversion of Flow in Intracranial VErtebral and Blood Blister-like Ruptured Aneurysms Trial: A Randomized Trial Comparing Pipeline Flow Diversion and Best-Standard-Treatment
A study testing Flow Diversion and Best Standard Therapy in people with Ruptured Aneurysm of Intracranial Artery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The purpose of the DIVERT study is to provide a prudent, controlled clinical context for the use of flow diversion, a promising option of yet unproven benefit, in the care of patients with acute blood blister-like and dissecting intradural aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ruptured Aneurysm of Intracranial Artery
- What is being tested?
- Flow Diversion and Best Standard Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- A patient affected with a blood blister-like aneurysm or a dissecting aneurysm, vertebral or at other sites, responsible for a recent subarachnoid hemorrhage (<14 days) for whom PED FD is considered an appropriate therapeutic option by the participating clinician. Current indications may be (but not restricted to) symptomatic blister-like aneurysms and dissecting intradural vertebral aneurysms.
Who cannot join
- Severe allergy, intolerance or bleeding disorder that prohibit the use of Acetyl Salicylic Acid (ASA), clopidogrel or other platelet inhibitors
- Acute hydrocephalus or intracranial hematomas necessitating urgent ventricular drainage or surgical evacuation (patients may be recruited after these urgent interventions have been performed)
- Absolute contraindication to endovascular treatment or anesthesia.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 4M1
About this study
Official title: Diversion of Flow in Intracranial VErtebral and Blood Blister-like Ruptured Aneurysms Trial Trial: A Randomized Trial Comparing Pipeline Flow Diversion and Best-Standard-Treatment
The purpose of the DIVERT study is to provide a prudent, controlled clinical context for the use of flow diversion, a promising option of yet unproven benefit, in the care of patients with acute blood blister-like and dissecting intradural aneurysms. Hence DIVERT is a simple, multicenter, randomized trial integrated into daily practice. DIVERT addresses the clinical dilemma of whether the use of PED FD truly is a safe and effective alternative to best standard treatment, defined as conventional methods of treatment or in some cases, observation. Selection criteria are few, to facilitate the recruitment of most affected patients confronted with these difficult aneurysms that their physician judges suitable for PED FD. The trial does not obstruct clinical care, does not include extra tests or risks beyond what is necessary and proven beneficial. Endpoints are simple, clinical, meaningful, valuable and resistant to bias. Follow-up visits and tests are "routine', imposing no extra burden on clinical transactions. Data is collected in simple case-report forms filled by physicians.
Read the detailed description
Ruptured blood blister-like (BB) and dissecting vertebral aneurysms are infrequent but devastating causes of subarachnoid hemorrhage (SAH), prone to acute rebleeding with poor clinical outcomes despite current surgical or endovascular treatment. Flow diversion (PED FD) with the Pipeline Endovascular Device (PED) is a promising treatment alternative to conventional management options.
The DIVERT trial is designed to provide a prudent, controlled clinical framework for offering the PED FD , a promising yet unproven option in the care of patients with acute blood blister-like or dissecting vertebral aneurysms. DIVERT is a care trial, designed as a simple, pragmatic, multicenter, randomized trial integrated into daily practice with inclusive selection criteria.
The investigators hypothesize that PED FD can decrease poor outcomes from 30 to 15%, compared to 'best standard treatment' (BST). BST is chosen prior to randomization amongst 4 options: observation, coiling with or without stenting, parent vessel occlusion or surgical clipping or wrapping. Patients are enrolled within 48 hours of SAH using standard 1:1 randomization between PED FD and BST after informed consent has been obtained from the patient or surrogate decision maker(s). Patients for whom no other option than PED FD appears feasible and safe will be included in a registry conducted alongside the trial.
Blister-like aneurysms and intradural dissections presenting with SAH have a high propensity for rebleeding and outcomes are poor in approximately one third of the cases, despite treatment using surgical or endovascular techniques.
- Conditions
- Ruptured Aneurysm of Intracranial Artery
- Being tested
- Flow Diversion, Best Standard Therapy
- Keywords
- Flow Diversion, Aneurysm, Intracranial, Cerebral, Vertebral, blood blister-like, ruptured aneurysm, Pipeline Flow Diversion, Pipeline Flow Diverter, Best-Standard Treatment
- Medical subject headings
- Aneurysm, Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow DiversionDevice
Best Standard TherapyDevice
Also called Best standard therapy, which may be any of the following:, B1. Conservative management when no surgical or endovascular treatment is considered possible or reasonable, B2. Conventional endovascular options including coiling with or without high-porosity stenting, and stent-in stent techniques, B3. Parent vessel occlusion, with or without bypass
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment with flow diversion | Experimental | Endovascular treatment with flow diversion, including standard management of thrombo-embolic risk. The goal of the treatment procedure is (as usual) to prevent rebleeding, while keeping treatment-related risks as low as possible.
This trial permits the interventionist or surgeon to use any device, technique or drug judged important to the safety and success of the endovascular or surgical procedure, at his/her discretion at any time during the procedure. It is imperative that the allocated procedure is conducted in the safest possible manner. The interventionist or surgeon may switch to an alternative BST or cross-over to the alternative treatment group, if it is in the best interest of the patient. Receives: Device: Flow Diversion |
| Best standard therapy | Active comparator | May be any of the following:
Conservative management when no surgical or endovascular treatment is considered possible or reasonable
Conventional endovascular options including coiling with or without high-porosity stenting, and stent-in stent techniques
Parent vessel occlusion, with or without bypass
Surgical clipping or clip-wrapping (including parent vessel occlusion as a salvage procedure).
Choice of best option is based on the location, anatomy, and particular circumstances, before randomization for this patient's aneurysm.
This trial permits the interventionist or surgeon to use any device, technique or drug judged important to the safety and success of the endovascular or surgical procedure, at his/her discretion at any time during the procedure. The interventionist or surgeon may switch to an alternative BST or cross-over to the alternative treatment group, if it is in the best interest of the patient. Receives: Device: Best Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological status of the patient
Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.
Measured: 3 months following treatment
Neurological status of the patient
Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.
Measured: at last follow-up (1 year following treatment, +/- 1 month)
Secondary outcomes (10)
Modified Rankin Scale score
Measured: within a month following treatment, and at 3 and 12 months post-treatment
Successful PED FD deployment/aneurysm clip-ligation/aneurysm coiling, with patency of parent arteries
Measured: within 24 hours after procedure, if appropriate
Peri-operative complications
Peri-operative complications (ischemic strokes and intracranial hemorrhages), defined as any severe adverse effect.
Measured: Within one month of treatment
Angiographic outcome
Angiographic outcome (invasive or non-invasive imaging) (last observation carried forward)
Measured: between 3-12 months following treatment
Number of days of hospitalization
Measured: Within a month following procedure
Discharge disposition/location
home; other hospital; rehabilitation facility; death
Measured: within a month following procedure
Any new stroke, neurological symptom or sign
Measured: during follow-up (between discharge and 1 year post-treatment)
Hospital re-admission
Measured: from initial discharge to one year following treatment
Hemorrhagic complications
Hemorrhagic complications, in any body system, related to antiplatelet medication or not.
Measured: within one year following treatment
Re-treatment of the index aneurysm
Measured: Within one year following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Rare aneurysms. No patient enrolled at site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Aneurysm of Intracranial ArteryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Raymond, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976026
- Sponsor's protocol ID
- CE13.114
- Acronym
- DIVERT
- Status last verified
- Nov 2016
- First submitted
- 22 Oct 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diversion of Flow in Intracranial VErtebral and Blood Blister-like Ruptured Aneurysms Trial Trial: A Randomized Trial Comparing Pipeline Flow Diversion and Best-Standard-Treatment
- ClinicalTrials.gov ID
- NCT01976026
- Acronym / sponsor ID
- DIVERT / CE13.114
- Conditions
- Ruptured Aneurysm of Intracranial Artery
- Keywords
- Flow Diversion, Aneurysm, Intracranial, Cerebral, Vertebral, blood blister-like, ruptured aneurysm, Pipeline Flow Diversion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Rare aneurysms. No patient enrolled at site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the DIVERT study is to provide a prudent, controlled clinical context for the use of flow diversion, a promising option of yet unproven benefit, in the care of patients with acute blood blister-like and dissecting intradural aneurysms. Hence DIVERT is a simple, multicenter, randomized trial integrated into daily practice. DIVERT addresses the clinical dilemma of whether the use of PED FD truly is a safe and effective alternative to best standard treatment, defined as conventional methods of treatment or in some cases, observation. Selection criteria are few, to facilitate the recruitment of most affected patients confronted with these difficult aneurysms that their physician judges suitable for PED FD. The trial does not obstruct clinical care, does not include extra tests or risks beyond what is necessary and proven beneficial. Endpoints are simple, clinical, meaningful, valuable and resistant to bias. Follow-up visits and tests are "routine', imposing no extra burden on clinical transactions. Data is collected in simple case-report forms filled by physicians.
Detailed description
Ruptured blood blister-like (BB) and dissecting vertebral aneurysms are infrequent but devastating causes of subarachnoid hemorrhage (SAH), prone to acute rebleeding with poor clinical outcomes despite current surgical or endovascular treatment. Flow diversion (PED FD) with the Pipeline Endovascular Device (PED) is a promising treatment alternative to conventional management options.
The DIVERT trial is designed to provide a prudent, controlled clinical framework for offering the PED FD , a promising yet unproven option in the care of patients with acute blood blister-like or dissecting vertebral aneurysms. DIVERT is a care trial, designed as a simple, pragmatic, multicenter, randomized trial integrated into daily practice with inclusive selection criteria.
The investigators hypothesize that PED FD can decrease poor outcomes from 30 to 15%, compared to 'best standard treatment' (BST). BST is chosen prior to randomization amongst 4 options: observation, coiling with or without stenting, parent vessel occlusion or surgical clipping or wrapping. Patients are enrolled within 48 hours of SAH using standard 1:1 randomization between PED FD and BST after informed consent has been obtained from the patient or surrogate decision maker(s). Patients for whom no other option than PED FD appears feasible and safe will be included in a registry conducted alongside the trial.
Blister-like aneurysms and intradural dissections presenting with SAH have a high propensity for rebleeding and outcomes are poor in approximately one third of the cases, despite treatment using surgical or endovascular techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment with flow diversion | Experimental | Device: Flow DiversionEndovascular treatment with flow diversion, including standard management of thrombo-embolic risk. The goal of the treatment procedure is (as usual) to prevent rebleeding, while keeping treatment-related risks as low as possible. This trial permits the interventionist or surgeon to use any device, technique or drug judged important to the safety and success of the endovascular or surgical procedure, at his/her discretion at any time during the procedure. It is imperative that the allocated procedure is conducted in the safest possible manner. The interventionist or surgeon may switch to an alternative BST or cross-over to the alternative treatment group, if it is in the best interest of the patient. |
| Best standard therapy | Active comparator | Device: Best Standard TherapyMay be any of the following: Conservative management when no surgical or endovascular treatment is considered possible or reasonable Conventional endovascular options including coiling with or without high-porosity stenting, and stent-in stent techniques Parent vessel occlusion, with or without bypass Surgical clipping or clip-wrapping (including parent vessel occlusion as a salvage procedure). Choice of best option is based on the location, anatomy, and particular circumstances, before randomization for this patient's aneurysm. This trial permits the interventionist or surgeon to use any device, technique or drug judged important to the safety and success of the endovascular or surgical procedure, at his/her discretion at any time during the procedure. The interventionist or surgeon may switch to an alternative BST or cross-over to the alternative treatment group, if it is in the best interest of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A patient affected with a blood blister-like aneurysm or a dissecting aneurysm, vertebral or at other sites, responsible for a recent subarachnoid hemorrhage (<14 days) for whom PED FD is considered an appropriate therapeutic option by the participating clinician. Current indications may be (but not restricted to) symptomatic blister-like aneurysms and dissecting intradural vertebral aneurysms.
Key exclusion criteria (3 listed)
- Severe allergy, intolerance or bleeding disorder that prohibit the use of Acetyl Salicylic Acid (ASA), clopidogrel or other platelet inhibitors
- Acute hydrocephalus or intracranial hematomas necessitating urgent ventricular drainage or surgical evacuation (patients may be recruited after these urgent interventions have been performed)
- Absolute contraindication to endovascular treatment or anesthesia.
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 |
|---|---|---|
| Flow Diversion | Device | Endovascular treatment with flow diversion |
| Best Standard TherapyAlso: Best standard therapy, which may be any of the following:, B1. Conservative management when no surgical or endovascular treatment is considered possible or reasonable, B2. Conventional endovascular options including coiling with or without high-porosity stenting, and stent-in stent techniques, B3. Parent vessel occlusion, with or without bypass | Device | Best standard therapy |
Primary outcome
Neurological status of the patient
Time frame: 3 months following treatment
Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.
Neurological status of the patient
Time frame: at last follow-up (1 year following treatment, +/- 1 month)
Neurological status graded according to the Rankin scale, defined as mRS>2, from any disease, treatment or other related causes.
10 secondary outcomes
Modified Rankin Scale score
Time frame: within a month following treatment, and at 3 and 12 months post-treatment
Successful PED FD deployment/aneurysm clip-ligation/aneurysm coiling, with patency of parent arteries
Time frame: within 24 hours after procedure, if appropriate
Peri-operative complications
Time frame: Within one month of treatment
Angiographic outcome
Time frame: between 3-12 months following treatment
Number of days of hospitalization
Time frame: Within a month following procedure
Discharge disposition/location
Time frame: within a month following procedure
Any new stroke, neurological symptom or sign
Time frame: during follow-up (between discharge and 1 year post-treatment)
Hospital re-admission
Time frame: from initial discharge to one year following treatment
Hemorrhagic complications
Time frame: within one year following treatment
Re-treatment of the index aneurysm
Time frame: Within one year following treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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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 principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow Diversion and Best Standard Therapy in people with Ruptured Aneurysm of Intracranial Artery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Neurological status of the patient (time frame: 3 months following treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2016.