Intracranial Arterial AneurysmNCT06731946
Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
An observational study of Intracranial Arterial Aneurysm, run by Yibin Fang at 1 site in China.
Trial summary
Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Arterial Aneurysm
- What is being tested?
- Flow diverting
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Chinese populations with intracranial aneurysms
Who may be able to join
- Age ≥ 18 years with a confirmed diagnosis of intracranial aneurysm.
- Imaging studies confirming suitability for Surpass Evolve Flow Diverter treatment.
- Aneurysms meeting flow diverter treatment indications (e.g., aneurysms larger than 4 mm).
- At least six months of follow-up data available post-treatment.
Who cannot join
- Patients with acutely ruptured aneurysms or significant bleeding.
- Patients with incomplete data or insufficient follow-up records.
Trial locations and contacts
1 site in 1 country.
About this study
Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
Read the detailed description
This study aims to retrospectively evaluate the efficacy and safety of the Surpass Evolve Flow Diverter in treating complex intracranial aneurysms. It seeks to assess long-term outcomes and complication rates while analyzing the impact of patient characteristics and aneurysm types on treatment effectiveness. By collecting data from multiple centers, the study ensures broad representativeness, ultimately providing valuable insights for clinical management on a global scale.
- Conditions
- Intracranial Arterial Aneurysm
- Being tested
- Flow diverting
- Keywords
- Intracranial Arterial Aneurysm, Surpass Evolve Flow Diverter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow divertingDevice
Flow diverter has become the standardized treatment method for Intracranial aneurysms (IAs), which is different from angioplasty, coiling, etc.
| Study group | Role | What they receive |
|---|---|---|
| Surpass Evolve Flow Diverter | Not described Receives: Device: Flow diverting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete aneurysm occlusion rate
Measured: 12(-3 ~ +6) months
Favorable prognosis rate
mRS score 0-1
Measured: 12(-3 ~ +6) months
Procedure-related complication rate
Measured: 12(-3 ~ +6) months
Secondary outcomes (5)
Procedural success rate
Measured: 12(-3 ~ +6) months
Perioperative complication rate
Measured: 12(-3 ~ +6) months
Neurological mortality rate
Measured: 12(-3 ~ +6) months
Incidence of postoperative stroke/TIA
Measured: 12(-3 ~ +6) months
Rates of postoperative intracranial hemorrhage and neurological deficits
Measured: 12(-3 ~ +6) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start29 Nov 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Arterial 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yibin Fang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yibin Fang, Shanghai Fourth People's Hospital Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731946
- Sponsor's protocol ID
- SYNXG202401
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT06731946
- Acronym / sponsor ID
- SYNXG202401
- Conditions
- Intracranial Arterial Aneurysm
- Keywords
- Intracranial Arterial Aneurysm, Surpass Evolve Flow Diverter
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yibin FangUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Dec 2024 (actual)
- 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.
Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
Detailed description
This study aims to retrospectively evaluate the efficacy and safety of the Surpass Evolve Flow Diverter in treating complex intracranial aneurysms. It seeks to assess long-term outcomes and complication rates while analyzing the impact of patient characteristics and aneurysm types on treatment effectiveness. By collecting data from multiple centers, the study ensures broad representativeness, ultimately providing valuable insights for clinical management on a global scale.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surpass Evolve Flow Diverter | – | Device: Flow diverting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese populations with intracranial aneurysms
Key inclusion criteria (4 listed)
- Age ≥ 18 years with a confirmed diagnosis of intracranial aneurysm.
- Imaging studies confirming suitability for Surpass Evolve Flow Diverter treatment.
- Aneurysms meeting flow diverter treatment indications (e.g., aneurysms larger than 4 mm).
- At least six months of follow-up data available post-treatment.
Key exclusion criteria (2 listed)
- Patients with acutely ruptured aneurysms or significant bleeding.
- Patients with incomplete data or insufficient follow-up records.
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 divertingFlow diverter has become the standardized treatment method for Intracranial aneurysms (IAs), which is different from angioplasty, coiling, etc. | Device | Surpass Evolve Flow Diverter |
Primary outcome
Complete aneurysm occlusion rate
Time frame: 12(-3 ~ +6) months
Favorable prognosis rate
Time frame: 12(-3 ~ +6) months
mRS score 0-1
Procedure-related complication rate
Time frame: 12(-3 ~ +6) months
5 secondary outcomes
Procedural success rate
Time frame: 12(-3 ~ +6) months
Perioperative complication rate
Time frame: 12(-3 ~ +6) months
Neurological mortality rate
Time frame: 12(-3 ~ +6) months
Incidence of postoperative stroke/TIA
Time frame: 12(-3 ~ +6) months
Rates of postoperative intracranial hemorrhage and neurological deficits
Time frame: 12(-3 ~ +6) months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Arterial Aneurysm, run by Yibin Fang at 1 site in China.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Complete aneurysm occlusion rate (time frame: 12(-3 ~ +6) months). The study lists 3 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 13 Dec 2024.