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| Name | Class |
|---|---|
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
| Nanyang Central Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PED Shield | Active Comparator | Subjects Treated with the PED Shield for Intracranial Aneurysms |
|
| LFD | Experimental | Subjects Treated with the LFD for Intracranial Aneurysms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFD | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 48 Hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-7 days postoperatively |
| Mortality and major disability rate during follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Li, MD | Contact | +8615038063905 | lli120253@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Chinese PLA General Hospital |
| OTHER |
| Yichang Central People's Hospital | OTHER |
| Shandong First Medical University | OTHER |
| Zhujiang Hospital | OTHER |
| Handan Central Hospital | OTHER |
| Kaifeng Central Hospital | OTHER |
| The First Affiliated Hospital of Henan Medical University | UNKNOWN |
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| PED Shield | Device | 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. |
|
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. |
| 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. | 180 (±30) days |
| Aneurysm complete occlusion rate | Complete occlusion rate of the target aneurysm assessed via the Raymond-Roy classification scale. | 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. | 180 (±30) days |
| Number of DWI positive lesions | The number of DWI positive lesions detected on postoperative magnetic resonance imaging (MRI). | Within 48 hours postoperatively |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |