A Multicenter Prospective Study of New Flow Diverter Stent on the Treatment of Intracranial Aneurysms in China (APRESENT)
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Study type
Funder types
Identifiers
Details and patient eligibility
About
Intracranial aneurysm, as a common cerebrovascular disease, has a variety of treatment methods, including surgical treatment and endovascular treatment. Among these treatment methods, flow diverters have attracted much attention due to their unique therapeutic principles. Flow diverters help promote thrombus formation within the aneurysm by altering the direction and dynamics of blood flow, thereby achieving the purpose of treatment. 1-5 Flow diverters such as the Pipeline™ device have been proven to be safe and effective for the treatment of intracranial aneurysms and have gradually been recognized as the preferred device for the management of intracranial aneurysms.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Signed informed consent form and agreement to comply with protocol requirements.
Age 22 to 80 years.
Diagnosed with intracranial wide-neck aneurysm and planned for treatment with a flow diverter stent.
Parent artery distal/proximal diameter compatible with available sizes and models of flow diverter stents, and treatment to be performed in accordance with the China NMPA-approved indications and instructions for use.
Exclusion criteria
- Need for treatment of another aneurysm in the affected territory of the target aneurysm using a different therapeutic modality during the study period.
Prior intracranial implant (e.g., coils) in the target intracranial aneurysm territory within 6 months before enrollment.
Prior surgery, including endovascular treatment, within 30 days before enrollment.
Modified Rankin Scale (mRS) score ≥ 3.
Any known contraindication to flow diverter stent treatment or antiplatelet therapy, including contraindications to dual antiplatelet therapy (DAPT).
Pre-existing stent/flow diverter placed in the parent artery of the target aneurysm location.
Investigator judges that the patient's health or the validity of study results (e.g., high risk of neurological events, conditions that may increase the chance of stroke) could be compromised by study participation.
Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
Known allergy to platinum or cobalt-chromium alloys (including major elements: platinum, cobalt, chromium, nickel, or molybdenum).
Trial design
Primary purpose
Allocation
Interventional model
Masking
280 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Hengwei Jin
Data sourced from clinicaltrials.gov
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