TCD-12261

JRCT ID: jRCT2042230075

Registered date:05/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unruptured, wide-necked intracranial aneurysm
• Date of first enrollment: 05/09/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Intravascular placement of the TCD-12261

Outcome(s)

Primary Outcome

Clinical Success
(1)Accuracy of placement to an aneurysm neck
(2)Patency of the stent
(3)Coils remain inside the aneurysm
(4)No major adverse cerebrovascular event related to the procedure or device within 30 days after procedure

Key inclusion & exclusion criteria

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

Include criteria

Subjects must meet the following criteria to be included in the study:
(1)Uunruptured, wide-necked (neck => 4mm or dome/neck ratio <2) intracranial, a diameter => 5 mm aneurysm, the parent artery is 2.0 - 4.0 mm.
(2)Difficult to treat with surgery or only embolization coils.
(3)Age is >= 18, =< 80 years at the time of informed consent.
(4)Patients understand the purpose and contents and then provide a signed informed consent form by his/her own will.
(5)follwing the rules, of this trial such as trial visit scedules, examinations.

Exclude criteria

At pre-registraton, patients will be excluded from the study for:
(1)Having intracranial masses such as tumors, abscesses, or other infections. Undergoing radiation therapy for head or neck tumors or sarcomas.
(2)History of bleeding diathesis, abnormal coagulation. Refusing a blood transfusion.
(3)Drugs required for EVT are contraindicated. Having allergies of acontrast agents. Needed Usage restrictions of acontrast agents.
(4)Hypersensitivity to metal, such as nickel-titanium and metal jewelry
(5)Life expectancy less than 6 months.
(6)Current participation in clinical study that has not completed primary endpoint evaluation or studies that may have an impact on the evaluation of this clinical trial.
(7)Have/will receive treatments that may have an impact on the evaluation of this clinil trial within 3 months prior to TCD-12261 surgery.
(8)History of heart disease or complication highly relevant to atrial fibrillation and cardiogenic embolism.
(9)Active bacterial infections.
(10)Pre-existing stents in place at the target aneurysm.
(11)Currently pregnant, planning to become pregnant during the course of the study.
(12)Considered ineligible for the study by the investigator.

At registraton, patients will be excluded from the study for:
(13)Uunruptured, wide-necked (neck < 4mm or dome/neck ratio >2) intracranial, a diameter < 5 mm aneurysm, the parent artery < 2.0mm or > 4.0 mm.
(14)Considered ineligible for the EVT treatment by the investigator.
(15)Ipsilateral arteriovenous malformations.
(16)Having other aneurysms needed to treat during the course of the study.
(17)Needed 2 or more stents to treat target aneurysm.

Related Information

• Primary Sponsor: Chiaki Chiba