Multi-institutional clinical test of TCD-14139

Phase 3

• Conditions: 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.

• Registration Number: JPRN-UMIN000014679
• Lead Sponsor: TERUMO CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-28
• Study Completion: 2016-02-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified