Subjects with a target unruptured intracranial aneurysm located along the internal carotid artery,anterior cerebral artery,middle cerebral artery,vertebral artery, and basilar artery have no applicability to previous treatment.
Conditions
Interventions
(1)Gain vascular access according to standard angiographic practice.(2)Place appropriate size guidecatheter according to standard practice.(3)Coaxially navigate a microcatheter (TCD-H) over a guidewir
Sponsors
TERUMO CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Subject whose age is >=20 and 80 >=years; (2)Subject fulfills study requirements, and the subject or his/her Legally Authorized Representative provides a signed informed consent form; (3)Negative pregnancy test in a female subject. (4)Subject commits to return to the investigational site for the 30-day, 6-month, and 12-month follow-up evaluations. (5)Subject has a single target aneurysm located in the following zones: - Petrous through superior hypophyseal segments of the ICA - Communicating segment of the ICA through A1 or M1 segment - Posterior Circulation (6)(7)AND fit any of the following criteria: Subject whose target aneurysm has a neck >=4mm or no discernible neck AND a size(maximum fundus diameter) >=10 mm OR subject has a fusiform aneurysm of any size requiring treatment OR Subject is a poor candidate for open surgical treatment because of prior surgical procedure, comorbidities or location limiting conventional surgical options OR Subject for whom exiting endovascular options (coiling, stent-assisted coiling) would be ineffective because the aneurysm is predisposed to recurrence due to having any of the following characteristics: a. Aneurysm has a maximum fundus diameter less than 10mm but >=7mm b. Aneurysm has any of the following morphologies: i. segmental parent artery dysplasia ii. aneurysm neck involving > 180 degrees of parent artery circumference iii. complex lobulations limiting stent/coiling as a treatment option iv. neck >=4mm or dome/neck ratio>2 (8)The parent artery diameter must be 2.5-5.0mm distal/proximal to the target intracranialaneurysm;
Exclusion criteria
Exclusion criteria: (1)(2)SAH in the last 60 days or intracranial hemorrhage in the last 30 days(3)Intracranial mass or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.(4)Symptomatic extracranial or intracranial stenosis of the parent artery(>50%) proximal to the target aneurysm;(5)Irreversible bleeding disorder.(6)Current alcohol or substance abuse.(7)uncontrolled severe hypertension >180 mm Hg or>115 mmHg,(8)cre 3.0mg/dL;(9)Hypersensitivity to metal, such as nickel-titanium and metal jewelry. (10)(11)Subject with contraindications or known allergies to anticoagulants or antiplatelets (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);Subject with documented contrast allergy, or other condition, that prohibits imaging.(12)Evidence of active infection at the time of treatment;(13)Presence of any of the unequivocal cardiac sources of embolism; (14)Intracranial stenting procedure associated with the target aneurysm; (15)Cerebral diagnostic angiogram that demonstrates an aneurysm that is not appropriate for endovascular treatment;(16)Subject has extracranial stenosis greater than 50% in the carotid artery of the targetaneurysm.(17)Subject has intracranial stenosis greater than 50% in the treated vessel(18)Subject has a mycotic or dissecting aneurysm.(19)Subject has a bifurcation.(20)Subject has a posterior circulation aneurysm.(21)Subjects aneurysm has significant branch exiting from dome of aneurysm.(22)Subject is harboring more than one aneurysm with both aneurysms requiring treatment at the same time.(23)Subject has an AVM in the area of the target aneurysm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint; Proportion of subjects who experience severe event related safty at 12 months post procedure. Primary Effectiveness: Proportion of treatment success within 12 months post procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Safety Endpoint Incidence of Adverse Events. Incidence of Adverse Device Effect. Incidence of Adverse Device Effect and procedure related Adverse Events. Incidence of Serious Adverse Events. Incidence of Serious Adverse Device Effec. Incidence of Adverse Device Effect and procedure related Serious Adverse Events. Incidence of significant adverse events.(thromboembolic event,hemorrhagic event) Physical finding. Incidence or worsening of neurologic signs/symptoms, as measured by NIHSS. Secondary Effectiveness Incidence of treatment success. In the evaluation of degree of obstruction. Incidence of successful delivery of the TCD-14139 System implant. Incidence of migration of the TCD-14139 System implant. Unplanned alternative treatment on the target IA within 12 months. Study Success Criteria Overall study success will be met if both the primary efficacy and primary safety endpoints are met. | — |
Countries
Japan
Contacts
Public Contactsatoshi yamamoto
TERUMO CORPORATION Clinical Development Department
Outcome results
None listed