Cerebral AneurysmNCT02281721
Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection
An observational study of Cerebral Aneurysm, run by Stryker Neurovascular at 19 sites in 9 countries.
Trial summary
The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Surpass Flow Diverter(s)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 19 sitesin 9 countries
- Study dates
- 18 Mar 2015to Dec 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: For the primary endpoint, the evaluable patient population will consist of all individuals treated with the Surpass Flow Diverter(s) who have provided consent, and who have completed their 12 month follow-up assessment.
Who may be able to join
- Patients who are to be treated with a Surpass Flow Diverter(s) will be eligible to participate in this registry. Patients will be enrolled on a consecutive basis.
Who cannot join
- This is a standard of care registry. Patients should be excluded if standard of care at a given site is such that they are not eligible for treatment with a Surpass Flow Diverter(s).
Trial locations and contacts
19 sites in 9 countries.
19 sites in 9 countries
France4 sites
Hopital Jean Minjoz
Besançon, 25030
APHP - Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270
Fondation Rothschild
Paris, 75020
Hopital Bretonneau
Tours, 37 000
Germany3 sites
Freiburg University Hospital
Freiburg im Breisgau, 79085
Klinikum Kassel
Kassel, 34125
Universitätsmedizin Mannheim
Mannheim, 68167
United Kingdom3 sites
Queen Elizabeth Hospital
Birmingham
The Walton center
Liverpool, L9 7LJ
Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust
Romford, Essex, RM7 0AG
Finland2 sites
Helsinki University Hospital
Helsinki, 00260
Turun yliopistollinen keskussairaala
Turku, 20521
Italy2 sites
San Martino Hospital
Genova, 16132
Neuroradiologia Azienda ILSS9
Treviso, 31100
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario Marques de Valdecilla
Santander, 39008
Sweden1 site
Karolinska University Hospital in Solna, Department of Neuroradiology
Stockholm, 171 16
About this study
Official title: Prospective, Observational, Multi-Center, Single-Arm, Consecutive Enrollment, Post-Marketing, International Registry of the Surpass™ Flow Diverter in Intracranial Arteries
The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.
Read the detailed description
This will be a prospective, observational, multi-center, single-arm, post-marketing, international registry with consecutive enrollment of a minimum of 150 patients treated with the Surpass Flow Diverter in accordance with the standard of care at up to 30 registry sites.
- Conditions
- Cerebral Aneurysm
- Being tested
- Surpass Flow Diverter(s)
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surpass Flow Diverter(s)Device
Endovascular placement of a Surpass Flow Diverter(s) for the treatment of an intracranial aneurysm(s)
| Study group | Role | What they receive |
|---|---|---|
| Single Group; Surpass Flow Diverter(s) | Individuals using the Surpass Flow Diverter(s) Receives: Device: Surpass Flow Diverter(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion
The proportion of patients with 100% aneurysm occlusion, based on an assessment of each patient's imaging at 12 months (± 180 days) post-procedure, and stratified across four aneurysm categories.
Measured: 12 months
Secondary outcomes (1)
Technical success assessed by deployment of the device with complete coverage of the aneurysm neck
Successful deployment of the device with complete coverage of the aneurysm neck.
Measured: Peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study start18 Mar 2015
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: Internal decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick A Brouwer, MD, Principal investigator, Karolinska Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281721
- Sponsor's protocol ID
- T4029
- Status last verified
- Jul 2021
- First submitted
- 30 Oct 2014
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Multi-Center, Single-Arm, Consecutive Enrollment, Post-Marketing, International Registry of the Surpass™ Flow Diverter in Intracranial Arteries
- ClinicalTrials.gov ID
- NCT02281721
- Acronym / sponsor ID
- T4029
- Conditions
- Cerebral Aneurysm
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Internal decision
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 3 Nov 2014 (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 this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.
Detailed description
This will be a prospective, observational, multi-center, single-arm, post-marketing, international registry with consecutive enrollment of a minimum of 150 patients treated with the Surpass Flow Diverter in accordance with the standard of care at up to 30 registry sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group; Surpass Flow Diverter(s) | – | Device: Surpass Flow Diverter(s)Individuals using the Surpass Flow Diverter(s) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For the primary endpoint, the evaluable patient population will consist of all individuals treated with the Surpass Flow Diverter(s) who have provided consent, and who have completed their 12 month follow-up assessment.
Key inclusion criteria (1 listed)
- Patients who are to be treated with a Surpass Flow Diverter(s) will be eligible to participate in this registry. Patients will be enrolled on a consecutive basis.
Key exclusion criteria (1 listed)
- This is a standard of care registry. Patients should be excluded if standard of care at a given site is such that they are not eligible for treatment with a Surpass Flow Diverter(s).
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 |
|---|---|---|
| Surpass Flow Diverter(s)Endovascular placement of a Surpass Flow Diverter(s) for the treatment of an intracranial aneurysm(s) | Device | Single Group; Surpass Flow Diverter(s) |
Primary outcome
Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion
Time frame: 12 months
The proportion of patients with 100% aneurysm occlusion, based on an assessment of each patient's imaging at 12 months (± 180 days) post-procedure, and stratified across four aneurysm categories.
1 secondary outcome
Technical success assessed by deployment of the device with complete coverage of the aneurysm neck
Time frame: Peri-procedural
Results and safety
The study was stopped early (reason given: Internal decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
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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.
Patrick A Brouwer, MD principal investigator
Karolinska Hospital
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Aneurysm, run by Stryker Neurovascular at 19 sites in 9 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Germany, United Kingdom, Finland, Italy and 4 more countries. 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 stopped early (reason given: Internal decision). Results are not available in the source record.
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?
Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion (time frame: 12 months). 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 14 Jul 2021.