Intracranial AneurysmsPRISMATICNCT07674004
Surface-Modified Flow Diverter for Intracranial Aneurysms: Assessment of Ischemic and Clinical Outcomes
A study testing LFD and PED Shield in people with Intracranial Aneurysms and Flow Diverter, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
Flow diverters (FDs) have become a mainstay of endovascular therapy for unruptured intracranial aneurysms (UIAs), yet their implantation carries an inherent risk of ischemic complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysms, Flow Diverter
- What is being tested?
- LFD and PED Shield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2026to 30 Sep 2027
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were diagnosed with unruptured intracranial aneurysms, and the lesions were evaluated to be suitable for endovascular treatment with flow diverter devices (PED Shield/Lattice).
- During the study period, only one target aneurysm per patient was treated, with the exception of segmental lesions, in which multiple aneurysms located within the same arterial segment were treated with a single or overlapping study devices.
- The target aneurysm was treated solely with flow diverter (FD) implantation in the current study.
- The age of enrolled patients ranged from 18 to 75 years old.
- Patients were capable of understanding the study-related informed consent information and provided written informed consent for the use of their clinical data for research purposes.
Who cannot join
- Patients with a prior history of endovascular treatment for the target aneurysm.
- Patients in the acute stage of cerebrovascular diseases (acute cerebral infarction or intracerebral hemorrhage with an onset time of ≤ 2 weeks).
- Patients complicated with other cerebrovascular disorders, including moyamoya disease, cerebrovascular malformations, and arteriovenous fistula.
- Patients with atherosclerotic changes in the parent artery of the target aneurysm that necessitated additional intraoperative endovascular interventions (e.g., balloon angioplasty or conventional stent implantation).
- Patients with a preoperative modified Rankin Scale (mRS) score greater than 2.
- Patients with any absolute contraindications to device treatment as specified in the Instructions for Use (IFU).
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- Patients enrolled in other clinical trials that may interfere with the primary or secondary endpoints of the present study.
- Patients with comorbidities that may interfere with neurological function evaluation, affect survival status, or impair the ability to complete follow-up visits.
- Pregnant or lactating female patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Li Li, MD, +8615038063905, lli120253@163.com
About this study
Official title: Prospective Randomized Controlled Trial of Surface-Modified Flow Diverter for Intracranial Aneurysms: Multicenter Assessment of Ischemic and Clinical Outcomes
Flow diverters (FDs) have become a mainstay of endovascular therapy for unruptured intracranial aneurysms (UIAs), yet their implantation carries an inherent risk of ischemic complications. The Pipeline Flex Embolization Device with Shield Technology (PED Shield) and the Lattice Flow Diverter (LFD) are two surface-modified FDs that have shown promising efficacy for mitigating procedure-related ischemic events in prior single-arm or retrospective series. Nevertheless, head-to-head comparative data between these two surface-modified flow diverters remain scarce, and prospective randomized clinical trials are warranted to corroborate their differential performance in lowering ischemic complication risks.This prospective, multicenter randomized controlled trial (RCT) was designed to compare the efficacy of PED Shield versus LFD in reducing ischemic complications after endovascular treatment of UIAs. A total of 196 eligible participants who meet the predefined inclusion and exclusion criteria will be enrolled in the trial. The primary outcome measure is the incidence of new diffusion-weighted imaging (DWI)-positive lesions on brain magnetic resonance imaging (MRI) within 48 hours after the procedure. The secondary outcome measures consist of perioperative symptomatic ischemic events, all-cause mortality and disability rate during the follow-up period, delayed aneurysm rupture at the 6-month follow-up, complete aneurysm occlusion rate, incidence of major in-stent stenosis (stenosis degree >50%) at the 6-month follow-up, and the number of new DWI-positive lesions within 48 hours post-procedure.
- Conditions
- Intracranial Aneurysms, Flow Diverter
- Being tested
- LFD, PED Shield
- Keywords
- intracranial aneurysms, flow dierters, surface-modified
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFDDevice
Subjects who meet the inclusion and exclusion criteria will undergo randomization after signing the study informed consent form. When a subject is randomly assigned to the LFD group, the operator will implant this flow diverter following standardized surgical procedures.
PED ShieldDevice
Subjects who meet the inclusion and exclusion criteria will undergo randomization after signing the study informed consent form. When a subject is randomly assigned to the PED Shield group, the operator will implant this flow diverter following standardized surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| PED Shield | Active comparator | Subjects Treated with the PED Shield for Intracranial Aneurysms Receives: Device: PED Shield |
| LFD | Experimental | Subjects Treated with the LFD for Intracranial Aneurysms Receives: Device: LFD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of patients with new positive diffusion-weighted imaging (DWI) lesions
The proportion of patients with newly developed DWI hyperintensities detected on magnetic resonance imaging (MRI) within 48 hours after the surgical procedure.
Measured: Within 48 Hours postoperatively.
Secondary outcomes (6)
Symptomatic neurological ischemic events
Symptomatic neurological ischemic events related to the target aneurysm, mainly including transient ischemic attack （TIA） and acute cerebral infarction, as adjudicated by the clinical event committee.
Measured: 0-7 days postoperatively
Mortality and major disability rate during follow-up
Proportion of patients with a modified Rankin Scale (mRS) score > 3 or an increase of ≥ 2 points in mRS score from baseline, as adjudicated by the clinical event committee.
Measured: 180 (±30) days
Rate of delayed aneurysm rupture
Incidence of intracranial hemorrhage caused by delayed rupture of the target aneurysm, as adjudicated by the clinical event committee. The time calculation starts from the first day after surgery.
Measured: 180 (±30) days
Aneurysm complete occlusion rate
Complete occlusion rate of the target aneurysm assessed via the Raymond-Roy classification scale.
Measured: 180 (±30) days
Incidence of target parent artery in-stent stenosis (>50%)
In-stent stenosis of the target parent artery was defined as stenosis degree >50%, which was evaluated by digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA) at 6 months after surgery.
Measured: 180 (±30) days
Number of DWI positive lesions
The number of DWI positive lesions detected on postoperative magnetic resonance imaging (MRI).
Measured: Within 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start21 May 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Nanyang Central Hospital, First Hospital of China Medical University, Chinese PLA General Hospital, Yichang Central People's Hospital, Shandong First Medical University, Zhujiang Hospital, Handan Central Hospital, Kaifeng Central Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674004
- Sponsor's protocol ID
- 2025-234
- Acronym
- PRISMATIC
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Surface-Modified Flow Diverter for Intracranial Aneurysms: Multicenter Assessment of Ischemic and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07674004
- Acronym / sponsor ID
- PRISMATIC / 2025-234
- Conditions
- Intracranial Aneurysms, Flow Diverter
- Keywords
- intracranial aneurysms, flow dierters, surface-modified
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Nanyang Central Hospital, First Hospital of China Medical University, Chinese PLA General Hospital, Yichang Central People's Hospital, Shandong First Medical University, Zhujiang Hospital, Handan Central Hospital, Kaifeng Central Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 21 May 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 Jun 2026 (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.
Flow diverters (FDs) have become a mainstay of endovascular therapy for unruptured intracranial aneurysms (UIAs), yet their implantation carries an inherent risk of ischemic complications. The Pipeline Flex Embolization Device with Shield Technology (PED Shield) and the Lattice Flow Diverter (LFD) are two surface-modified FDs that have shown promising efficacy for mitigating procedure-related ischemic events in prior single-arm or retrospective series. Nevertheless, head-to-head comparative data between these two surface-modified flow diverters remain scarce, and prospective randomized clinical trials are warranted to corroborate their differential performance in lowering ischemic complication risks.This prospective, multicenter randomized controlled trial (RCT) was designed to compare the efficacy of PED Shield versus LFD in reducing ischemic complications after endovascular treatment of UIAs. A total of 196 eligible participants who meet the predefined inclusion and exclusion criteria will be enrolled in the trial. The primary outcome measure is the incidence of new diffusion-weighted imaging (DWI)-positive lesions on brain magnetic resonance imaging (MRI) within 48 hours after the procedure. The secondary outcome measures consist of perioperative symptomatic ischemic events, all-cause mortality and disability rate during the follow-up period, delayed aneurysm rupture at the 6-month follow-up, complete aneurysm occlusion rate, incidence of major in-stent stenosis (stenosis degree >50%) at the 6-month follow-up, and the number of new DWI-positive lesions within 48 hours post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PED Shield | Active comparator | Device: PED ShieldSubjects Treated with the PED Shield for Intracranial Aneurysms |
| LFD | Experimental | Device: LFDSubjects Treated with the LFD for Intracranial Aneurysms |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients were diagnosed with unruptured intracranial aneurysms, and the lesions were evaluated to be suitable for endovascular treatment with flow diverter devices (PED Shield/Lattice).
- During the study period, only one target aneurysm per patient was treated, with the exception of segmental lesions, in which multiple aneurysms located within the same arterial segment were treated with a single or overlapping study devices.
- The target aneurysm was treated solely with flow diverter (FD) implantation in the current study.
- The age of enrolled patients ranged from 18 to 75 years old.
- Patients were capable of understanding the study-related informed consent information and provided written informed consent for the use of their clinical data for research purposes.
Key exclusion criteria (9 listed)
- Patients with a prior history of endovascular treatment for the target aneurysm.
- Patients in the acute stage of cerebrovascular diseases (acute cerebral infarction or intracerebral hemorrhage with an onset time of ≤ 2 weeks).
- Patients complicated with other cerebrovascular disorders, including moyamoya disease, cerebrovascular malformations, and arteriovenous fistula.
- Patients with atherosclerotic changes in the parent artery of the target aneurysm that necessitated additional intraoperative endovascular interventions (e.g., balloon angioplasty or conventional stent implantation).
- Patients with a preoperative modified Rankin Scale (mRS) score greater than 2.
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 |
|---|---|---|
| LFDSubjects who meet the inclusion and exclusion criteria will undergo randomization after signing the study informed consent form. When a subject is randomly assigned to the LFD group, the operator will implant this flow diverter following standardized surgical procedures. | Device | LFD |
| PED ShieldSubjects who meet the inclusion and exclusion criteria will undergo randomization after signing the study informed consent form. When a subject is randomly assigned to the PED Shield group, the operator will implant this flow diverter following standardized surgical procedures. | Device | PED Shield |
Primary outcome
The incidence of patients with new positive diffusion-weighted imaging (DWI) lesions
Time frame: Within 48 Hours postoperatively.
The proportion of patients with newly developed DWI hyperintensities detected on magnetic resonance imaging (MRI) within 48 hours after the surgical procedure.
6 secondary outcomes
Symptomatic neurological ischemic events
Time frame: 0-7 days postoperatively
Mortality and major disability rate during follow-up
Time frame: 180 (±30) days
Rate of delayed aneurysm rupture
Time frame: 180 (±30) days
Aneurysm complete occlusion rate
Time frame: 180 (±30) days
Incidence of target parent artery in-stent stenosis (>50%)
Time frame: 180 (±30) days
Number of DWI positive lesions
Time frame: Within 48 hours postoperatively
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 1 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LFD and PED Shield in people with Intracranial Aneurysms and Flow Diverter, run by Henan Provincial People's Hospital 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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?
Contact Li Li, MD (+8615038063905, lli120253@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of patients with new positive diffusion-weighted imaging (DWI) lesions (time frame: Within 48 Hours postoperatively.). 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 1 Jul 2026.