A Multicentre, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Flow Diverters (PFMD-001) for Cerebral Aneurysms

JRCT ID: jRCT2052240073

Registered date:24/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cerebral aneurysm
• Date of first enrollment: 24/06/2024
• Target sample size: 130
• Study type: Interventional
• Intervention(s): Deliver therapeutic equipment to lesions using unapproved devices during cerebrovascular treatment.

Outcome(s)

Primary Outcome

Efficacy: Complete occlusion of the treated aneurysm and patency of the parent artery at 12 months post-treatment angiography, with no additional treatment of the treated aneurysm in the 12-month post-operative period.

Safety: No severe stroke or neurological deaths attributable to treatment or the device within 12 months of treatment.

Secondary Outcome

(1) Technical success of treatment (implantation of the device in a position that covers the area of cerebral aneurysm to be treated).
(2) Procedural success of treatment (technical success without serious adverse events or equipment failure due to treatment or procedure).
(3) Occlusion of the treated aneurysm after 12 months of treatment
(4) Patency of the parent artery after 12 months of treatment (no stenosis or occlusion >50%)
(5) Re-treatment within 12 months after treatment.
(6) All causes of mortality within 30 days and until 12 months of treatment.
(7) Neurological deaths within 30 days and at 12 months of treatment.
(8) All strokes within 30 days and until 12 months of treatment.
(9) Stroke in the treated vasculature within 30 days and until 12 months of treatment.
(10) Severe stroke in the treated vasculature within 30 days and until 12 months of treatment.
(11) Serious adverse events within 30 days and until 12 months of treatment.
(12) Adverse events (classification and aggregation by neurological and non-neurological systems) and equipment failure.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Patients aged between 18 and 80 years at the time of consent.
(2) Have cerebral aneurysms* suitable for treatment with the flow diverter.
*Wide-neck cerebral aneurysms (neck>=4 mm or a dome-to-neck ratio <2), spindle-shaped and beaded cerebral aneurysms with a maximum diameter of 5 mm or more, located in the internal carotid artery, anterior cerebral artery (A1), middle cerebral artery (M1), vertebral artery and basilar artery.
(3) Parent vessel diameter between 1.75 mm and 5.0 mm.
(4) Patients who are independent in daily activities (modified Rankin Scale 2 or less)
(5) Patients who have given written consent.

Exclude criteria

(1) Patients in the acute phase of rupture (within 14 days of onset)
(2) A stent was previously implanted in the neck of the cerebral aneurysm to be treated.
(3) There is more than 50% stenosis distal or proximal to the cerebral aneurysm.
(4) Patients who have other intracranial lesions scheduled for treatment within 1 year.
(5) Unable to receive heparin or antiplatelet drugs for medical reasons.
(6) History nickel-titanium alloy allergy.
(7) History of serious allergy to contrast media.
(8) Difficult to follow up for one year.
(9) Patients participating in other clinical trials.
(10) Pregnancy or possible pregnancy or unwillingness to use contraception (women only)
(11) Patients that the investigator or sub-investigator considers inappropriate for clinical trial participation.

Related Information

• Primary Sponsor: Arakawa Yoshiki
• Secondary Sponsor: Japan Lifeline Co.,Ltd.