VivaStent Feasibility Study

N/ANot Yet RecruitingNCT07515781

V-Flow 2115 enrolled

Overview

Subjects are enrolled in the study following signature of the Informed Consent Form and confirmation of eligibility criteria. During the screening/baseline phase, demographic and clinical data, medical history, concomitant medications, available imaging (contrast-enhanced CTV or MRV), and THI and HIT-6 questionnaires are collected. Pre-procedural medication are initiated one week prior to the procedure, in accordance with standard medical practice. Subjects are admitted prior to the procedure according to local practice. Required laboratory tests, neurological assessments (modified Rankin Scale and NIHSS), and confirmation of informed consent are completed prior to any study-specific procedures. The index procedure includes cerebral venography with confirmation of a significant transverse-sigmoid sinus stenosis and a pressure gradient greater than 5 mmHg. Following confirmation of procedural eligibility and appropriate vessel measurements, the VivaStent is deployed. Post-deployment venography and pressure measurements are performed to assess stent patency and hemodynamic outcome. Procedural data, administered medications, and adverse events are recorded. Following the procedure, subjects are hospitalized for observation as per local protocol. Prior to hospital discharge (or at Day 7 post-procedure, whichever occurs first), the THI questionnaire, concomitant medications, and adverse events are documented. Follow-up visits are conducted at 1 month, 3 months, and 12 months post-procedure. Each visit includes assessment of THI and HIT-6 questionnaires, documentation of concomitant medications and adverse events. Contrast-enhanced CTV or MRV is performed at the 3-month and 12-month visits to evaluate stent position and patency. Subject exit from the study is defined as completion of follow-up, subject withdrawal, investigator-initiated withdrawal, loss to follow-up, or death.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1 Male or female ≥ 18 years of age at the time of screening. 2 An adult patient, experiencing pulsatile unilateral tinnitus for at least 1-year, which resolves with ipsilateral neck compression. 3 The patient suffers severe debilitating venous pulsatile tinnitus grade 4 or 5 according to the Tinnitus Handicap Inventory (Newman et al., 1996) 4 The patient has ≥50% stenosis of transverse-sigmoid sinus on the ipsilateral side to the pulsatile tinnitus, as identified by CTV or MRV. 5 The patient is a candidate for transverse-sigmoid sinuses stenting procedure using an off-label stent. 6 The patient is willing to sign an informed consent and participate in the study. 7 Intra-procedural criteria:Venographic confirmation of significant transverse-sigmoid sinus stenosis on the ipsilateral side of the pulsatile tinnitus. • Pressure gradient ≥ 5 mm Hg, as measured by catheter manometry. Exclusion Criteria: * 1 Presence of Dural Arteriovenous Fistula (AVF), cerebral vascular lesions, malformation, or aneurysm that can explain the pulsatile tinnitus on CTV or MRV. 2 Transverse-sigmoid sinus vessel size \<5 mm or \>10 mm. 3 Anemia, defined as Hb \< 8 g/dl. 4 Chronic renal failure Creatinine \> 1.6 mg/dl 5 History of stroke or transient ischemic attack (TIA). 6 History of severe carotid atherosclerotic disease. 7 History of AF or other stroke risk factors. 8 History of coagulopathy, hypercoagulability, deep vein thrombosis or pulmonary embolism. 9 History of severe chronic obstructive pulmonary disease (COPD) or other severe respiratory disease. 10 History of heart failure, dilated cardiomyopathy, or congenital heart conditions. 11 Pregnant (confirmed by a pregnancy test) or lactating woman 12 Otologic disorders, such as chronic hearing loss, or other ENT disorders that can cause tinnitus. 13 Allergic to iodinated contrast material despite premedication, or to Nitinol. 14 Contra-indication to aspirin, clopidogrel or other anticoagulants. 15 Protected adults, such as person subject to legal protection, person deprived of liberty, and person unable to express his consent. 16 Participating in another medical device or drug study.

Outcomes

Primary Outcomes

Major adverse events

Major adverse events, procedure or device related, defined as any of the following through 3 months FU: * Bleeding related to the target vein * Thrombosis at the target lesion site * New neurological deficit * Death

Time frame: 3 months

Secondary Outcomes

Feasibility of the VivaStent device and procedure

Ability to implant the stent at the target site, and demonstrate its patency at the end of the procedure by pressure gradient on catheter manometry and/or visually by digital subtraction venography

Time frame: End of procedure