Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis
Phase: NA
Conditions: Tinnitus, Pulsatile Tinnitus, Venous Sinus Stenosis, Dural Sinus Stenosis
Sponsor: Weill Medical College of Cornell University

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 1 
 
 
 
Venous Sinus Stenting to Treat Intractable Pulsatile 
Tinnitus Caused By Venous Sinus Stenosis 
 
 
 
Updated IDE G150164 Protocol  
May 12, 2017 
 
 
NCT02734576 
 
 
 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 2 
 
TABLE OF CONTENTS 
1. Sponsor information 
2. Report of Prior Investigations 
3. Investigational Plan 
4. Schema 
5. Case Report Form 
6. Manufacturing Information 
7. Investigator Information 
8. IRB Information 
9. Sales Information 
10. Labeling 
11. Informed Consent 
12. List of attached documents 
 
 
 
 
 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
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Sponsor/ Primary Investigator:  
Athos Patsalides MD MPH 
 
 
 
 
 Department of Neurological Surgery  
 
 
 
 
 Division of Interventional Neuroradiology 
 
 
 
 
 Weill Cornell Medical College 
 
 
 
 
 525 East 68th Street, Box 99 
 
 
 
 
 New York, NY 10065 
 
 
 
 
 Tel: 212-746-2821 
 
 
 
 
 Fax: 212-746-8111 
 
 
 
 
 Email: atp9002@med.cornell.edu 
 

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REPORT OF PRIOR INVESTIGATIONS 
We seek permission to use the Cordis Precise Pro Rx Nitinol Stent System to treat 
intracranial dural venous sinus stenosis in patients with severe venous pulsatile tinnitus 
and severe lateral venous sinus stenosis. 
 
The sponsor of this application has performed prior use of the device to treat 
symptomatic stenosis of dural venous sinuses in a series of more than 20 patients in the 
United States. Specifically, we have IDE approval to use this same device in a 
prospective clinical trial titled “Venous sinus stenting for Idiopathic Intracranial 
Hypertension refractory to medical therapy” (IDE# G090050), and 10 patients have been 
enrolled in this trial (last annual report attached). The anatomic location and the 
procedure of stent placement are identical in this protocol and IDE# G090050. Moreover, 
10 additional patients with symptomatic venous sinus stenosis were treated outside the 
trial. There were no significant neurological or device related complications. Recently, a 
paper was published (Baomin et al. 2014) reporting on the results of 46 cases of pulsatile 
tinnitus and lateral (transverse and sigmoid) venous sinus stenosis treated with stenting 
using the Cordis Precise Pro Rx Nitinol Stent System. The procedure was successful in 
all 46 patients, resulting in resolution of tinnitus in all patients. There were no 
neurological or device related complications. Therefore, there are at least 66 cases of the 
Cordis Precise Pro Rx Nitinol Stent System used to treat stenosis of the lateral (transverse 
and sigmoid) venous sinus without severe procedural or neurological adverse events. 
 
The Cordis Precise Pro Rx Nitinol Stent System Cordis is approved by the FDA under 
Premarket Approval (PMA) for carotid revascularization in patients at high-risk for 
adverse events from carotid endarterectomy and: 
1. ≥ 50% common or internal carotid artery stenosis with associated neurological 
symptoms, or ≥ 80% common or internal carotid artery stenosis without 
associated neurological symptoms, and 
2. Vessel diameter 4-9 mm at the target lesion. 
 

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INVESTIGATIONAL PLAN 
HYPOTHESIS AND OBJECTIVES 
Papers published during the last seven years show that in patients with venous pulsatile 
tinnitus and significant venous sinus stenosis, tinnitus improves or resolves after stenting 
in the vast majority of patients. There have been 100 patients with venous sinus stenosis 
and venous pulsatile tinnitus reported in the literature (Table 1, attached document). 
Fifty-four of these patients had Idiopathic Intracranial Hypertension and venous pulsatile 
tinnitus and the rest had isolated venous pulsatile tinnitus.  After stenting, the venous 
pulsatile tinnitus resolved in 93/100, improved in 4/100 and remained unchanged in 
3/100. This corroborates our experience at Cornell; out of 18 patients with venous sinus 
stenosis and venous pulsatile tinnitus treated by the PI with stenting, 17 had immediate 
resolution of the tinnitus. In one patient the tinnitus remained unchanged (anecdotal 
evidence; paper submitted for publication). 
 
Our hypothesis is that venous pulsatile tinnitus is caused by the venous sinus stenosis and 
stenting would offer effective and long-term resolution of these symptoms. Our project 
aims to evaluate the long-term efficacy of venous sinus stenting in patients with severe 
intractable venous pulsatile tinnitus. 
 
Primary Outcome: 
- 
The primary outcome will be complete or near-complete resolution of tinnitus at 
12 months in more than 75% of treated patients. 
- 
Primary Outcome Measure: No, slight, mild, or moderate tinnitus (grades 1, 2, 
and 3) on Tinnitus Handicap Inventory at 1, 6, 12, and 24 months 
Secondary Outcomes: 
- 
Long-term success of treatment (clinical recurrence rates over 24 months) 
- 
Long-term patency of the stent (stent patency 12 months after treatment) 
- 
Rate and severity of adverse events probably or possibly related to the treatment 
within a 24-month period 

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BACKGROUND AND SIGNIFICANCE 
Introduction 
Tinnitus is the conscious perception of sound that seems to arise from the ear 
when no external acoustic stimulus is present. It is a complex symptom rather than a 
syndrome or disease and can present itself as many possible sounds, including 
whooshing, ringing, whistling, buzzing, or clicking. These abnormal noises can either be 
perceived in one or both ears, and can occur intermittently or constantly. It is estimated 
that tinnitus affects about 25.3% in the general population in the United States which 
corresponds to an estimate of 80 million adults (Shargorodsky, 2010).   
     Tinnitus has many variants and can be categorized by its level of audibility, rhythm, 
and etiology. In terms of audibility, tinnitus which can be heard by a physician, either 
with a stethoscope or listening closely to the ear, is termed objective tinnitus. Subjective 
tinnitus, on the other hand, is audible only to the patient. Tinnitus can also be categorized 
by its rhythm. Pulsatile tinnitus sound synchronizes with the rhythm of the patient’s 
heartbeat, in contrast to non-pulsatile tinnitus, which includes all other noises. 
Contributing to their different rhythm patterns, the source of sound for pulsatile and non-
pulsatile tinnitus are also different. Pulsatile tinnitus usually has a physical source of 
sound in the tissues of the ear, in particular, due to turbulence of blood flow surrounding 
the ear. This disturbance can occur in either arterial or venous locations. Non-pulsatile 
tinnitus, on the other hand, typically results from a problem with the nerves. 
Pulsatile Tinnitus 
Of the tinnitus population, 4% is estimated to have pulsatile tinnitus, which is 
roughly a population of 3.2 million (Liyanage et al. 2006). Although pulsatile tinnitus 
affects a small percentage of the population, it can be dangerous if left undiagnosed. 
Pulsatile tinnitus is mostly reported as an annoying rather than severe symptom, however 
there is a sub-set of patients who experience it to a debilitating degree. The perceived 
sounds can become so intense and frequent as to become incapacitating, cause difficulty 
sleeping or concentrating, seriously interfere with work, increase stress, and create 
feelings of depression or anxiousness. Some patients may even become diagnosed with 
psychological problems (Baomin et al. 2014). Furthermore, pulsatile tinnitus may be the 

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only presenting symptom of an underlying serious condition such as: arteriosclerosis, 
vascular tumor, idiopathic intracranial hypertension, arteriovenous malformation, or 
aneurysm.   
The evaluation of pulsatile tinnitus is thus crucial to the detection of a potentially 
more serious disease. Evaluation of pulsatile tinnitus consists of a thorough physical 
examination paired with blood tests and radiological imaging. Careful examination must 
be done by the physician to confirm that the sound heard is in sync with the heartbeat and 
the rhythm increases with physical activity (Herraiz et al. 2007). Due to its lower 
pressure, though, pulsatile tinnitus of venous etiology may be more difficult to detect as 
the loudness of flow is much lower compared to arterial pulsatile tinnitus. As a result, 
pulsatile tinnitus of venous etiology may not be detected by auscultation and may be 
misdiagnosed as subjective tinnitus (Baomin et al. 2014). Pulsatile tinnitus, especially 
venous, can also be confirmed by the clinician through the compression of the internal 
jugular vein ipsilateral to the tinnitus. Doing so will often decrease or stop the perceived 
sound by the patient (Signorelli et al. 2011). Blood testing and radiological imaging is 
used after physical examination to confirm the cause of pulsatile tinnitus. Depending on 
the suspected etiology, various tests can be appropriate. Anemia or hyperthyroidism can 
be tested for with blood work. Magnetic Resonance Imaging (MRI/MRA/ MRV) can 
confirm a vascular malformation such as arteriovenous malformation and dural 
arteriovenous fistula, venous sinus thrombosis, venous sinus stenosis, venous sinus 
diverticulum, or idiopathic intracranial hypertension. Carotid arteriosclerosis, a tortuous 
carotid, and cardiac murmur can be confirmed with an eco-doppler electrocardiogram. 
Lastly, a CT scan can confirm presence of a tympanic/jugular glomus, aberrant carotid, or 
alteration of the jugular bulb (Herraiz et al. 2007). 
Etiologies of Pulsatile Tinnitus 
As mentioned previously, pulsatile tinnitus can have different etiologies: arterial, 
arteriovenous and venous origin. Possible arterial etiologies include atherosclerosis, 
carotid aneurysm, dissection of the carotid or vertebral artery, and fibromuscular 
dysplasia. Arteriovenous causes include arteriovenous malformation, dural arteriovenous 
fistula, paraganglioma, and Paget’s Disease. Venous etiologies can include idiopathic 

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intracranial hypertension, venous diverticulum, venous stenosis (stenosis of the internal 
jugular vein, transverse sinus, sigmoid sinus, or jugular bulb), a high or dehiscent jugular 
bulb, and a dehiscent sigmoid plate (Mundada et al. 2014). A review of the current 
literature at the time by Hofmann et al. 2013 indicated that the majority of pulsatile 
tinnitus cases (486 total) were of venous origin; 28% were due to venous causes while 
23% were arterial, 18% were arteriovenous, and 31% were due to other or unknown 
causes. More than half of the venous cases of pulsatile tinnitus were due to idiopathic 
intracranial hypertension, which is recently known to be associated with venous stenosis. 
A retrospective review of CTA and CTV scans in 30 patients further indicated that the 
prevalent venous cause for pulsatile tinnitus was stenosis of some kind (N=16), with 
stenosis of the internal jugular vein being the most common cause (N=13) (Mundada et 
al. 2014). Sismanis et al. 1998 reviewed 145 patients with pulsatile tinnitus and found 
that the greatest proportion of patients (39%) had idiopathic intracranial hypertension. 
Venous sinus stenosis may have a role in the pathogenesis of IIH with a high proportion 
of IIH patients also having venous stenosis (Farb et al. 2003).  
Efficacy and safety of current therapeutic options 
Possible treatments for non-severe tinnitus include masking therapies, hearing 
devices, tinnitus retraining therapies, and acoustic neural stimulation. However, for 
patients with severe tinnitus, more invasive methods are available, such as cochlear 
implants for patients with sensorineural hearing loss, stereotactic radiosurgery for 
patients with vestibular schwannomas, and deep brain stimulation for patients with 
concomitant movement disorders (Soleymani et al. 2011).  
For patients with severe pulsatile tinnitus and venous etiology, surgical vein 
ligation and endovascular treatment represent possible treatment options. Although there 
have been documented immediate and long-term relief of pulsatile tinnitus from jugular 
vein ligation surgery (Golueke et al. 1987; Buckwalter et al. 1983; Nehru et al. 1993; 
Aikoye et al. 2012; Ott 1977; Duvillard et al. 2004), there have been mixed results 
(Zhang et al. 2010). Zhang et al. reported that out of 12 patients, 7 reported relief of 
tinnitus in less than one week after surgery while 5 reported no relief. However, during 
long-term follow-up of at least 1 year after surgery (to which 5 patients were lost), only 2 

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patients reported relief of tinnitus, 4 reported no relief, and 1 reported worsening. 
Furthermore, a warning was published by Jackler et al. 2001 regarding serious neurologic 
complaints after jugular vein ligation. These included headaches, vision deterioration, 
and DVS thrombosis.  Mahasin et al. 1998 also reported a case of transverse sinus 
thrombosis and cerebral venous infarction after venous ligation.  
Reports on venous sinus stenting to treat pulsatile tinnitus in 100 patients (Table 1, 
attached document) 
Little has been published regarding endovascular treatment of pulsatile tinnitus 
due to venous stenosis in particular. We conducted a search of the literature available on 
PubMed detailing the outcomes of endovascular treatment of venous stenosis leading to 
pulsatile tinnitus and found that all were retrospective case reports or case series reports 
(Mathis et al. 1997, Donnet et al. 2008, Arac et al. 2009, Ahmed et al. 2011, Fields et al. 
2013, Signorelli et al. 2011, Radvany et al. 2013, Baomin et al. 2014). From the search, 
100 patients (Table 1) were found to have had endovascular treatment (stenting alone and 
stenting with angioplasty). Of those 100 patients, all but 3 patients reported resolved or 
improved tinnitus following the procedure. At follow-up of at least 2 months (ranging up 
to maximum 9 years), all treatments were considered successful with complete resolution 
of tinnitus except for 1 case which reported the return of tinnitus at a low level around 8 
months (Mathis et al. 1997). All cases also reported long-term stent patency at follow-up. 
8 patients experienced re-stenosis adjacent to the stent, 7 of which required re-stenting 
and 1 shunt placement. Only two cases experienced serious adverse events. One patient 
experienced vein perforation which eventually lead to a subdural hematoma. Another 
patient experienced subdural, subarachnoid and intracranial bleeding.  
Baomin et al.’s (2014) paper was the most extensive report of endovascular 
treatment of pulsatile tinnitus due to venous stenosis. Forty-six cases were examined of 
patients who had failed medical treatment and masking therapies. Angioplasty and 
stenting were performed and all 46 patients reported immediate relief of tinnitus upon 
recovery from anesthesia. At 3-month follow-up, 2 patients reported recurrence of 
nonpulsatile tinnitus but this disappeared in both patients at the 6-month follow-up.  
 

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Our experience treating patients with Idiopathic Intracranial Hypertension and 
pulsatile tinnitus using venous sinus stenting 
 
Our institution has had success treating patients (N=20) who have idiopathic 
intracranial hypertension (IIH) concomitant with pulsatile tinnitus (N=18). In addition to 
pulsatile tinnitus, IIH patients have symptoms of headache, diplopia, visual field deficits, 
hearing loss, and vertigo. These patients typically undergo a regimen of medication as the 
first line of treatment. If the IIH becomes refractory to maximal medication, surgery 
(shunt placement) or stenting are options for treatment. Stenting of the dural venous sinus 
has been shown to eliminate tinnitus among pseudotumor cerebri patients (Mathis et al. 
1997), and we were able to replicate this effect in our study. We enrolled patients in the 
FDA approved trial “Venous sinus stenting in patients with idiopathic intracranial 
hypertension refractory to medical therapy” over a three-year period from January 2012-
December 2014. Patients eligible for venous stenting outside the trial were enrolled in a 
prospective database. Out of the 20 patients, 18 experienced pulsatile tinnitus. Nine 
patients presented with grade-4, 5 patients had grade-3, and 2 patients each had grade-2 
and grade-1 tinnitus. Out of eighteen patients with IIH and pulsatile tinnitus treated with 
venous sinus stenting, there was immediate resolution of tinnitus in seventeen patients. 
All patients had unilateral distal transverse-sigmoid sinus stenting. There was no 
recurrence of tinnitus for the duration of follow-up period. The 1 patient who had 
persistent tinnitus after the procedure had grade-1 tinnitus and did not report any change 
in severity. No serious neurological adverse events occurred after the procedure. All non-
serious adverse events were treated without the need for invasive treatment. Of these, 
seven patients experienced headaches afterwards and were treated with steroids, one 
patient developed a small retroperitoneal hematoma, and another patient developed free 
intra-abdominal hemorrhagic fluid collection a few days after the procedure that was 
attributed to a ruptured hemorrhagic ovarian cyst. There were no neurological adverse 
events or device related complications. 
From these results, we conclude that stenting is a safe and effective treatment for 
pulsatile tinnitus in the pseudotumor cerebri population. We believe that these successful 
results can be replicated in our proposed study for all patients who experience venous 

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pulsatile tinnitus and who have venous stenosis as the etiology. The presence of stenosis 
causes turbulent venous flow that is transmitted to the ear via the temporal bone. The 
immediate resolution of tinnitus supports this argument, as the alternative explanation 
(normalization of CSF pressure) is not immediate post-stenting but rather than a more 
delayed effect.  
Significance of the Proposed Project 
There have been few published studies that examine the efficacy and safety of 
endovascular treatments on patients with pulsatile tinnitus with venous stenosis. Despite 
the limited experience with venous sinus stenting to treat pulsatile tinnitus, preliminary 
results show that venous sinus stenting could represent a viable alternative for refractory 
pulsatile tinnitus patients with venous sinus stenosis. The purpose of our study is to 
evaluate the safety and efficacy of this procedure in a controlled fashion, using strict 
inclusion and exclusion criteria, and long-term clinical and imaging follow-up. We hope 
to provide robust data regarding the safety and efficacy of venous sinus stenting for 
patients with pulsatile tinnitus. 
 
DEVICE DESCRIPTION 
We selected the Cordis PRECISE PRO Nitinol Stent System because it is a relatively 
flexible stent that can be successfully navigated in the target area. It has been used 
extensively for the treatment of carotid stenosis and has enough radial force to maintain 
the stenosis open. Another advantage of this stent is that it can be delivered via a 5F or 6F 
guide catheter system, as opposed to other systems that require 6F guide catheters or 
more). The Cordis PRECISE PRO Rx Nitinol Stent System consists of a nitinol self-
expanding stent preloaded on a .065" (1.65 mm) or .078" (1.98 mm) sheathed delivery 
system. The delivery system consists mainly of an inner shaft and an outer sheath with 
radiopaque markers. The inner shaft consists of a support member and wire lumen. The 
proximal portion of the support member is comprised of a hub connected to a stainless 
steel wire and hypotube, and distally of a stainless steel coil. The wire lumen originates 
distally in a catheter tip and terminates proximally at a guidewire exit port designed to 
accept a .014" (0.36 mm) guidewire. The outer sheath has a proximal shaft and distal 

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outer sheath with a nominal working length of 135 cm. The self-expanding stent is 
constrained within the space between the inner shaft and the distal outer sheath, located 
between distal and proximal stent markers on the inner shaft. The stent expands to its 
unconstrained diameter when released from the deployment catheter. Upon deployment, 
the stent forms an open lattice and pushes outward on the luminal surface, helping to 
maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the 
stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than 
the unconstrained diameter of the stent. 
 
We are currently using the same device for the same procedure in another study 
with different indications (IDE# G090050). Device-related information was provided 
by the manufacturer to the FDA during that application. Since the device and site of 
implantation (venous sinuses; transverse and sigmoid sinuses) is the same we will be 
obliged if the FDA would refer to the same information provided by the 
manufacturer. We are happy to provide additional information as needed. 
 
METHODOLOGY  
The proposed research is a prospective single-arm clinical trial. The aim of the study is to 
evaluate the effectiveness of dural sinus stenting in patients with severe intractable 
venous pulsatile tinnitus. 
Inclusion and Exclusion Criteria 
Inclusion criteria: 
- 
Severe or catastrophic venous pulsatile tinnitus defined as Grades 4 or 5 on 
Tinnitus Handicap Inventory 
- 
50% or more stenosis of the lateral venous sinus on MRV or CTV, ipsilateral to 
the side of more severe tinnitus 
- 
Length of stenosis ≤ 70mm  
- 
Transstenotic gradient ≥ 4mm Hg evidenced by venous manometry 
- 
Failure of conservative or non-surgical therapies (including sound therapy, sound 
masking, hearing aids, tinnitus retraining (desensitization) therapy. Failure is 

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defined as Grades 4 or 5 on the Tinnitus Handicap Inventory despite prior 
treatments that have lasted for at least 3 months. 
- 
Adults, age > 18 years 
- 
Informed consent signed by the patient 
Exclusion criteria 
- 
Tinnitus contralateral to dominant narrowed side for patients with bilateral 
transverse sinus stenosis 
- 
Arterial Pulsatile Tinnitus 
- 
Dural Arteriovenous Fistula of other vascular malformation of the brain, head or 
neck 
- 
Paragangliomas 
- 
Non-pulsatile tinnitus 
- 
Otologic disorders 
- 
Disorders involving vestibular system and balance 
- 
Visual Field Defects or Papilledema consistent with increased intracranial 
pressure 
- 
Lateral venous sinus thrombosis 
- 
Contra-indication to iodinated contrast 
- 
Contra-indication to antiplatelet therapy 
- 
Contra-indication to general anesthesia 
- 
Pregnancy or plans for immediate pregnancy 
Screening Process 
The study will be announced to physicians via mail, email, presentations and talks. The 
information about the study will be available to the public on the Internet. All patients 
with complaints of tinnitus and who have failed previous non-invasive treatments will 
undergo comprehensive evaluation by an ENT physician, which will include 
comprehensive medical history and full head and neck exam. Otologic evaluation will 
consist of binocular microscopy, tuning fork exam, pneumatic otoscopy, audiogram, 
tympanometry, and auscultation for audible bruit. If indicated, imaging studies will be 
obtained as part of the standard tinnitus evaluation. For patients with pulsatile tinnitus, 

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vascular imaging studies of the brain, MRA, MRV, CTA, CTV, will be ordered. Imaging 
protocols for tinnitus vary depending on the patient’s history and exam. All patients with 
venous pulsatile tinnitus considered for the trial will have at least MRA and MRV studies 
done as part of the work-up of venous pulsatile tinnitus. Patients with contraindication to 
MRI scans will be evaluated with CTA and CTV instead. This imaging work-up is 
important for screening and selection of patient but is not experimental and is not part of 
the trial. It should be done however within 6 months from enrollment. In addition to the 
previously mentioned imaging studies, every patient will be evaluated with an MRI of the 
Head and Temporal Bone (Internal Auditory Canal protocol) in order to rule out the 
presence of other causes of venous pulsatile tinnitus. Patients with contraindication to 
MRI will be evaluated with CT of the Head and Temporal Bone. The patients who are 
diagnosed with venous pulsatile tinnitus and in whom presence of venous sinus stenosis 
is confirmed by imaging studies, will be informed about the trial and provided with the 
contact information for enrollment. As there is variability in the normal diameter of the 
transverse venous sinuses in terms of the entire length of the sinus (Ayanzen 2014), a 
pathologic stenosis will be defined as a >50% decrease in caliber in a focal area or 
segment of the sinus when compared to the normal diameter before and after.  
 
All patients will be required to have a comprehensive work-up of tinnitus and ENT 
evaluation within 6 months of enrollment in the trial. 
 
Eligible patients will meet with the investigators to discuss inclusion and exclusion 
criteria, procedural details, risks and alternatives and sign the IRB consent form. 
 
Venous sinus stenting procedure 
Pre-procedure anti-thrombotic regimen 
Patients will receive daily aspirin 325mg and clopidogrel (Plavix®) 75 mg for 7 days 
prior to the intervention.  
 
 

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Direct Retrograde Cerebral Venography (DRCV) and Manometry  
The first part of the procedure is to perform a venography and manometry study, using 
standard angiographic techniques under local anesthesia. Vascular access is obtained from the 
femoral vein with placement of a 6 French sheath. Then the right or left jugular vein (per 
MRV or CTV findings) is catheterized with a 6 French guide catheter. A microcatheter is 
advanced distal to the stenosis and venography is performed. If at least 50% venous sinus 
stenosis is confirmed, venous sinus manometry is performed proximally and distally to the 
stenosis with a microcatheter. It is important to perform this part of the procedure without 
general anesthesia because general anesthesia may cause artificially elevated venous sinus 
pressures. Sinus catheterization with the soft microcatheters used for DRCV is painless and 
generally well tolerated. If the venous pressure gradient across the stenosis is ≥ 4 mmHg, we 
will proceed with stenting. 
Venous sinus stenting 
The procedure requires general anesthesia because stent navigation into the venous 
sinuses can be painful. Vascular access is obtained from the femoral vein and a 6 French 
sheath catheter is positioned in the jugular vein. Subsequently, a microcatheter is 
navigated using standard neurointerventional techniques into the superior sagittal sinus. 
A venogram will be performed with contrast injection via the microcatheter to confirm 
the location and degree of stenosis. After the venogram, the microcatheter will be 
exchanged for an intravascular ultrasound catheter, and intravascular ultrasound will be 
performed to confirm degree of stenosis. Following this step, the intravascular ultrasound 
catheter will be withdrawn and balloon angioplasty will be performed across the stenosis, 
followed by deployment of a self-expandable stent (Cordis Precise-Pro Stent). An 
embolic protection device is not required and will not be used because there is no risk of 
cerebral embolism. After the catheters are removed, hemostasis at the puncture site is 
achieved with manual compression. In patients with stenosis on the dominant transverse 
sinus, the stent is placed in the dominant side. In patients with co-dominant transverse 
sinuses and bilateral stenosis, the stent is placed across the stenosis on the side of worse 
tinnitus.  
 

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Immediate post-procedure care 
Each patient will be admitted to ICU for overnight monitoring. Patients will be 
discharged home 24 hours after the procedure and will continue aspirin 325mg daily and 
clopidogrel (Plavix®) 75mg daily for 1 month, after which time they will return for a 
follow-up office visit. Plavix will be discontinued one month after the procedure and the 
patients will continue on aspirin (325mg daily) alone for 11 more months (total time on 
aspirin = 12 months). Typically, patients with coronary or carotid atherosclerosis treated 
with stent placement are prescribed aspirin and clopidogrel for 1-3 months, followed by 
aspirin alone indefinitely. This regimen is essential to prevent in-stent thrombosis and 
distal thromboembolism. Since there is no atherosclerotic disease in the venous sinuses 
and the risk of late in-stent thrombosis and distal thromboembolism is low, the risks of 
long-term anti-thrombotic treatment outweigh the possible benefits. 
 
Follow-up (Patient Flow Chart, page 28) 
Office visits 
Office visits with neurologic evaluation will be performed at one, six, twelve, and 
twenty-four months after treatment. At this time the patients will also fill the Tinnitus 
Handicap Inventory Questionnaire. The visits will last about 45 minutes. 
 
Audiometric assessment 
Audiometric assessment will be performed at the three-month mark after stenting to 
assess inner ear function. 
 
Imaging studies 
Magnetic Resonance Venogram (MRV) will be done at 12 months after the stent. If 
MRV is contraindicated, Computed Tomographic Venogram (CTV) will be performed 
instead. 
 
 
 

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Other treatments 
Patients will be expected to discontinue all prior treatments so as to effectively measure 
the sole effect of stenting. 
 
Endpoints 
Primary Endpoints: 
- 
Safety Endpoint: absence of procedure related and device related complications. 
- 
Efficacy Endpoint: 
o Improvement of more than one grade in the Tinnitus Handicap Inventory 
Questionnaire at 1, 6, 12, and 24 months after stent placement. 
Secondary Endpoints: 
-     No recurrence of tinnitus within 24 months after treatment 
-     Stent patency at 12 months after treatment 
-     Adverse events probably or possibly related to the treatment within a 24-month 
period after treatment 
 
Number of Patients 
We wish for permission to enroll 20 patients in this study, all at New York 
Presbyterian/Weill Cornell Medical Center. 
 
Data Analysis 
Data from all patients enrolled in the study will be reported. 
We will calculate and report the proportion of patients for each endpoint. 
 
ADVERSE EVENTS AND ASSESSMENT OF RISKS 
Risk assessment and prevention: 
- 
Risks related to antithrombotic therapy: intracranial or systemic hematoma. 
Antithrombotic therapy is important to prevent stent thrombosis. According to the 
literature and our experience in patients with carotid and intracranial stenting, the 
risks related to anticoagulation are minimal. The benefit of administering two 

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medications (aspirin and clopidogrel) for 1 month and then continuing with aspirin 
alone has been demonstrated in large studies in patients with cardiac, carotid and 
intracranial stents. We will ask all female patients of childbearing age to avoid 
becoming pregnant during the time-course of anticoagulation. We will also instruct 
all patients to avoid contact sports and trauma. 
- 
Risks related to general anesthesia: nausea, vomiting, fever, dizziness, headache, 
drowsiness, hoarseness, and sore throat. 
Experienced anesthesiologists will administer general anesthesia using standard 
techniques. Pre-procedure evaluation and standard protocol for patient preparation 
(i.e. empty stomach) will be used to minimize the risks. 
- 
Risks related to femoral vein puncture: hematoma at puncture site, pain at puncture 
site, infection, and thrombophlebitis. 
To minimize the risks of femoral vein puncture we will use standard angiographic 
techniques in a sterile environment. In patients with difficulty in accessing the 
femoral vein (obesity), ultrasound can be used to guide the puncture. 
- 
Risks related to venous sinus stent placement: venous rupture, venous thrombosis or 
occlusion, intracranial hematoma, progressive visual loss, stroke, death.  
Although venous sinus stenting is a new procedure, review of the literature shows that 
complications are rare. In only two cases, retrograde venous angiography 
demonstrated thrombosed stent in the immediate postoperative course, necessitating 
thrombolysis. In these two cases, it was not mentioned whether the procedure was 
performed under anticoagulation only or if antiplatelet therapy was also administered. 
In addition to the cases reporting venous sinus stenting for IIH, there is an additional 
recent report of treatment of 10 dural arteriovenous fistulas of the transverse sigmoid 
sinus using similar techniques of self-expanding stent placement and balloon 
angioplasty (Levrier O et al. 2006). In this series, one patient experienced a brain 
parenchyma hematoma secondary to the occlusion of a superficial cortical draining 
vein. That patient was not pre-medicated with anticoagulation prior to the procedure 
and since then the authors started using clopidogrel for 3 days prior to the procedure 
without further complications. All subjects of this protocol will be pretreated with 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 19 
 
antiplatelet agents before the procedure (aspirin and clopidogrel). Pretreatment with 
these medications before the stent placement is routinely performed for patients 
undergoing coronary, carotid and intracranial stents. In addition, the procedure will be 
done under systemic administration of heparin, also routinely used for endovascular 
procedures. Therefore, the risk of stent or cortical vein thrombosis will be minimal. 
- 
Risks related to administration of iodinated contrast: contrast allergy, contrast 
induced nephropathy.  
To minimize the risk of contrast allergy and nephropathy, a standard screening 
questionnaire for iodinated contrast will be reviewed before the procedure. Patients at 
risk for allergy (i.e. prior severe allergic reaction) or at risk for contrast nephropathy 
(i.e. history or evidence of renal function impairment) will be excluded from the 
study (see exclusion criteria). 
- 
Risks related to MRI scan: minimal risks. 
We will use standard equipment and protocols. We will screen all patients for 
contraindications to MRI using standard questionnaire and interview.  
Risks related to gadolinium (MRI contrast): contrast allergy, nephrogenic systemic 
fibrosis 
Patients with compromised renal function are excluded from the study (see exclusion 
criteria) and thus the risk of nephrogenic systemic fibrosis from the use of MRI 
contrast is minimal. 
- 
Risks related to invasion of privacy: minimal risks. 
All personal data and medical records will be kept confidential according to hospital 
regulations and legal requirements. No participant in this study will be identified 
personally in any reports or publications. 
 
Definition of Adverse Events 
The investigators will determine the seriousness, intensity, and causality of an adverse 
experience associated with the use of the test procedure (i.e., experiences where there is a 
reasonable possibility that the experience may have been caused by the test procedure) 
based on the following definitions: 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 20 
 
1. Serious Adverse Experiences  
The definition of a serious adverse event (SAE) is any of the following: 
• Any death that occurs while the patient is enrolled in the study including the 
follow-up period or within 30 days of completing the study.  
• Immediately life-threatening adverse event.  
• Requires inpatient hospitalization. 
• Prolongation of an existing hospitalization. 
• Congenital anomaly/birth defect. 
• Medically important event* 
• Disability/incapacity (persistent or significant) 
*Medically important events that may not result in death, be life-threatening or 
require hospitalization may be considered a serious adverse experience when, based 
upon appropriate medical judgment, the experience may jeopardize the patient or 
subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in the definition. 
2. Unexpected Adverse Experience  
An unexpected adverse experience is any adverse device experience, the specificity 
or severity of which is not consistent with those noted in the current research 
protocol.  This refers to any adverse device experience that has not been previously 
observed, rather than from the perspective of such an experience not being anticipated 
from the pharmacologic properties of the product.  
3. Non-serious Adverse Experiences  
All other adverse experiences, not fulfilling the previous definitions, are classified as 
non-serious. 
Documenting Adverse Experiences:  
All adverse experiences are to be accurately recorded on the Adverse Events & 
Description of AE columns of the patient’s CRF.  Each experience will be categorized as 
either: serious AE, non-serious AE, or unexpected AE (see CRF).  The date of onset as 
well as the duration of the experience will be recorded.  In addition, the method used to 
treat the adverse experience and the outcome of the adverse experience will also be 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 21 
 
noted.  The investigator will attempt to assess the relationship of the experience 
(unrelated, remote, possible, probable, related) to the test procedure.  
 
Reporting SAEs, Unexpected Adverse Experiences, and Patient Deaths 
1. Time-frame for Reporting:  
Any harm experienced by a participant related to the research procedure, intervention, 
and/or device when ALL of the following three (3) conditions are met will be reported 
within 7 calendar days:  
 
 1. The harm is “unexpected” when its specificity and severity are not accurately 
reflected in the WCMC consent document and protocol AND  
 
2. The harm is “related or possibly related”, where there is a reasonable 
possibility that the harm may have been caused by the research procedure or 
intervention AND  
 
3. The harm suggests that the research places subjects at greater risk of harm 
(including physical, psychological, economic or social harm) than was 
previously known or recognized 
 
In addition to the above, any unanticipated adverse effect (any serious adverse effect on 
health or safety or any life threatening problem or death) will be reported within 7 
calendar days that is EITHER:  
1. Caused by, or associated with, a device if that effect, problem, or death was 
not previously identified in nature, severity, or degree of incidence in the 
investigational plan or IDE application (including a supplementary plan or 
application); OR  
2. Any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of participants. 
 
2.  Information to be provided by the Investigator 
At the time of the report, the investigator must transmit information regarding the 
following: 

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Updated IDE; May 12, 2017, Page: 22 
 
· 
Underlying diagnosis and extent of disease 
· 
Dates of procedure 
· 
Description of event, including date of onset and duration 
· 
Date of death (if applicable) 
· 
Intervention(s) required 
· 
Concomitant therapy (including regimen(s) and indication) 
· 
Pertinent laboratory data/diagnostic test (including dates) 
· 
Pertinent medical history 
· 
Severity of the adverse experience 
· 
Relationship of the adverse experience to research study treatment 
· 
Outcome of the adverse experience 
 
Follow-up Information on an SAE:  
Appropriate diagnostic tests should be performed and therapeutic measures, if indicated, 
should be instituted.  Appropriate consultation and follow-up evaluations should be 
carried out until the event has resolved or is otherwise explained.  Follow-up data 
concerning the SAE (e.g., diagnostic test reports, physician's summaries, etc.) will also be 
submitted. 
 
Review of an SAE:  
After an SAE, enrollment will be halted until the DSMB reviews the SAE and determines 
that the study can be continued. Additionally, the PI will notify the FDA and will review 
each serious and unexpected adverse experience report and further evaluate the 
relationship of this adverse experience to the test device and to the patient’s underlying 
disease.  Based on this assessment, a decision will be made concerning the need for 
further action.  The primary consideration governing further action is whether new 
findings affect the safety of other patients participating in the clinical research study.  If 
the discovery of a new adverse experience related to the test device raises concern over 
the safety of its continued administration to patients, the PI will take immediate steps to 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 23 
 
notify the IRB and all investigators participating in clinical studies of the test drugs used 
in this research protocol.  
 
Further action required may include any of the following:   
· 
Modification of the research protocol. 
· 
Discontinuation or suspension of the research study. 
· 
Alteration of the informed consent process by modification of the existing consent 
form and informing current research study participants of new findings. 
· 
Modification of previously identified expected adverse experiences lists to include 
adverse experiences newly identified as test procedure-related. 
 
CONDITIONS FOR TERMINATION 
1. Discontinuing patients from the study 
Every effort will be made to keep the patient on the research study. However, in the event that 
a patient is withdrawn from the research study, the investigator should document the reasons 
for withdrawal as thoroughly as possible and notify the PI. This evaluation should include 
final observations, as required by the research protocol at the time of the patient’s withdrawal.  
The reason(s) for early termination must be clearly documented on the appropriate page of the 
patient’s case report form (CRF).  A CRF must be completed for any patient who receives 
ANY amount of treatment on this research study. 
 
Criteria for Early Termination of Treatment under this Research Protocol 
1) Significant deviation from the research protocol or eligibility criteria. Such patients 
will be considered protocol violations and will be removed from research study. 
2) Patients who develop a concurrent illness, which, in the opinion of the investigator, 
would prevent their safe completion of treatment or required research study-related 
evaluations. 
3) Patients who are non-compliant with the research study or follow-up procedures. 
4) Patients who withdraw consent and elect to terminate their participation in the research 
study. 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 24 
 
5) The occurrence of a grade 3 or greater hematologic toxicity, persisting 7 days or 
longer according to NCI CTCAE VERSION 4.03. 
6) Termination of the research study by the Sponsor. 
 
2. Study termination 
The study will be discontinued if a serious adverse event (SAE) that is unexpected and 
protocol-related occurs in more than two of the first five or more than three of the first ten 
procedures. 
 
STUDY MONITORING 
The study will be monitored by the Weill Cornell Medical College Data Safety 
Monitoring Board (WCMC DSMB). 
Data Safety Monitoring Board  
1300 York Avenue, Box #89 
Telephone: 646-962-8192  
Fax: 646-962-0533  
E-mail: dsmb@med.cornell.edu 
 
Adverse events will be reported to the WCMC DSMB according to the same policies as 
they will be reported to the FDA and WCMC IRB: 
 
Reporting SAEs, Unexpected Adverse Experiences, and Patient Deaths 
1. Time-frame for Reporting:  
Any harm experienced by a participant related to the research procedure, intervention, 
and/or device when ALL of the following three (3) conditions are met will be reported 
within 7 calendar days:  
 
 1. The harm is “unexpected” when its specificity and severity are not accurately 
reflected in the WCMC consent document and protocol AND  

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 25 
 
 
2. The harm is “related or possibly related”, where there is a reasonable 
possibility that the harm may have been caused by the research procedure or 
intervention AND  
 
3. The harm suggests that the research places subjects at greater risk of harm 
(including physical, psychological, economic or social harm) than was 
previously known or recognized 
 
In addition to the above, any unanticipated adverse effect (any serious adverse effect on 
health or safety or any life threatening problem or death) will be reported within 7 
calendar days that is EITHER:  
1. Caused by, or associated with, a device if that effect, problem, or death was 
not previously identified in nature, severity, or degree of incidence in the 
investigational plan or IDE application (including a supplementary plan or 
application); OR  
2. Any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of participants. 
 
2.  Information to be provided by the Investigator 
At the time of the report, the investigator must transmit information regarding the 
following: 
· 
Underlying diagnosis and extent of disease 
· 
Dates of procedure 
· 
Description of event, including date of onset and duration 
· 
Date of death (if applicable) 
· 
Intervention(s) required 
· 
Concomitant therapy (including regimen(s) and indication) 
· 
Pertinent laboratory data/diagnostic test (including dates) 
· 
Pertinent medical history 
· 
Severity of the adverse experience 
· 
Relationship of the adverse experience to research study treatment 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 26 
 
· 
Outcome of the adverse experience 
 
In addition, a cumulative list of unexpected AEs and serious AEs will be reported after 
every 5 patients, as determined by the WCMC DSMB. Detailed, narrative descriptions of 
each AE from the last report will accompany the cumulative list. 
 
 
 
 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 27 
 
REFERENCES 
 
1. Ahmed RM, Wilkinson M, Parker GD, Thurtell MJ, Macdonald J, McCluskey PJ, Allan 
R, Dunne V, Hanlon M, Owler BK, Halmagyi GM. Transverse 
sinus stenting for idiopathic intracranial hypertension: a review of 52 patients and of 
model predictions. AJNR Am J Neuroradiol. 2011;32(8):1408-14. doi: 
10.3174/ajnr.A2575. Epub 2011 Jul 28. 
2. Aikoye AA1, Tang TY, Meyer FJ. Local anaesthetic surgical treatment of severe 
objective pulsatile tinnitus: a useful technique. Ann R Coll Surg Engl. 2012;94(4):e139-
40. doi: 10.1308/003588412X13171221498820. 
3. Arac A, Lee M, Steinberg G, Marcellus M, Marks M. Efficacy of endovascular stenting 
in dural venous sinus stenosis for the treatment of idiopathic intracranial hypertension. 
Neurosurg Focus. 2009; 27 (5):E14. 
4. Ayanzen RH, Bird CR, Keller PJ, McCully FJ, Theobald MR, Heiserman JE. Cerebral 
MR venography: normal anatomy and potential diagnostic pitfalls. AJNR Am J 
Neuroradiol. 2000;21(1):74-8. 
5. Baomin L, Yongbing S, Xiangyu C. Angioplasty and stenting for intractable pulsatile 
tinnitus caused by dural venous sinus stenosis: a case series report. Otol Neurotol Off Publ 
Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2014;35(2):366-370. 
doi:10.1097/MAO.0b013e3182990d52. 
6. Buckwalter JA, Sasaki CT, Virapongse C, Kier EL, Bauman N. Pulsatile tinnitus arising 
from jugular megabulb deformity: a treatment rationale. Laryngoscope. 
1983;93(12):1534-9. 
7. Donnet AL, Metellus P, Levrier O, Mekkaoui C, Fuentes S, Dufour H, Conrath 
J, Grisoli F. Endovascular treatment of idiopathic intracranial hypertension: clinical and 
radiologic outcome of 10 consecutive patients. Neurology. 2008;70(8):641-7. doi: 
10.1212/01.wnl.0000299894.30700.d2. 
8. Duvillard C, Ballester M, Redon E, Romanet P. Pulsatile tinnitus cured by mastoidectomy. 
Ann Otol Rhinol Laryngol. 2004;113(9):730-733. 
9. Farb RI, Vanek I, Scott JN, et al. Idiopathic intracranial hypertension: the prevalence 
and morphology of sinovenous stenosis. Neurology. May 13 2003;60(9):1418-1424. 

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Updated IDE; May 12, 2017, Page: 28 
 
10. Fields JD, Javedani PP, Falardeau J, Nesbit GM, Dogan A, Helseth EK, Liu 
KC, Barnwell SL, Petersen BD. Dural venous sinus angioplasty and stenting for 
the treatment of idiopathic intracranial hypertension. J Neurointerv Surg. 2013 Jan 
1;5(1):62-8. doi: 10.1136/neurintsurg-2011-010156. Epub 2011 Dec 5. 
11. Golueke PJ, Panetta T, Sclafani S, Varughese G. Tinnitus originating from an abnormal 
jugular bulb: treatment by jugular vein ligation. J Vasc Surg. 1987 Sep;6(3):248-51. 
12. Herraiz C, Aparicio JM. Diagnostic clues in pulsatile tinnitus. Acta Otorrinolaringol 
Esp. 2007; 58(9):426-33. 
13. Hofmann E, Behr R, Neumann-Haefelin T, Schwager K. Pulsatile tinnitus: imaging and 
differential diagnosis. Dtsch Arztebl Int. 2013;110(26):451-8. doi: 
10.3238/arztebl.2013.0451. 
14. Jackler RK, Brackmann DE, Sismanis A. A warning on venous ligation for pulsatile 
tinnitus. Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 
2001;22(3):427-428. 
15. Levrier O, Metellus P, Fuentes S, Manera L, Dufour H, Donnet A, Grisoli F, Bartoli JM, 
Girard N. Use of a self-expending stent with balloon angioplasty in the treatment of dural 
arteriovenous fistulas involving the transverse and/or sigmoid sinus: functional and 
neuroimaging-based outcome in 10 patients. J Neurosurg. 2006;104(2):254-263. 
16. Liyanage SH, Singh A, Savundra P, Kalan A. Pulsatile tinnitus. J Laryngol Otol. 
2006;120(2):93-97. doi:10.1017/S0022215105001714. 
17. Mahasin ZZ, Saleem M, Gangopadhyay K. Transverse sinus thrombosis and venous 
infarction of the brain following unilateral radical neck dissection. J Laryngol Otol. 
1998;112(1):88-91. 
18. Mathis JM, Mattox D, Malloy P, Zoarski G. Endovascular treatment of pulsatile tinnitus 
caused by dural sinus stenosis. Skull Base Surg. 1997;7(3):145-150. 
19. Ott PM. [Venous tinnitus (author’s transl)]. Laryngol Rhinol Otol (Stuttg). 
1977;56(4):339-341. 
20. Nehru VI, al-Khaboori MJ, Kishore K. Ligation of the internal jugular vein in venous 
hum tinnitus. J Laryngol Otol. 1993;107(11):1037-8. 
21. Radvany MG1, Solomon D, Nijjar S, Subramanian PS, Miller NR, Rigamonti D, Blitz 
A, Gailloud P, Moghekar A. Visual and neurological outcomes following endovascular 

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Updated IDE; May 12, 2017, Page: 29 
 
stenting for pseudotumor cerebriassociated with transverse sinus stenosis. J 
Neuroophthalmol. 2013 Jun;33(2):117-22. doi: 10.1097/WNO.0b013e31827f18eb. 
22. Shargorodsky J, Curhan GC, Farwell WR. Prevalence and characteristics of tinnitus 
among US adults. Am J Med. 2010;123(8):711-718. doi:10.1016/j.amjmed.2010.02.015. 
23. Signorelli F, Mahla K, Turjman F. Endovascular treatment of two concomitant causes of 
pulsatile tinnitus: sigmoid sinus stenosis and ipsilateral jugular bulb diverticulum. Case 
report and literature review. Acta Neurochir (Wien). 2012;154(1):89-92. doi: 
10.1007/s00701-011-1202-3. 
24. Sismanis A. Pulsatile tinnitus. A 15-year experience. Am J Otol. 1998;19(4):472-477. 
Soleymani T, Pieton D, Pezeshkian P, Miller P, Gorgulho AA, Pouratian N, De Salles 
AA. Surgical approaches to tinnitus treatment: A review and novel approaches. Surg 
Neurol Int. 2011;2:154. doi: 10.4103/2152-7806.86834. 
23. Zhang Y, Wang W, Dai C, Chen L. [Diagnosis and management of pulsatile tinnitus of 
venous origin]. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi J Clin 
Otorhinolaryngol Head Neck Surg. 2010;24(6):267-269. 
 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
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Patient Flow Chart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pulsatile tinnitus  
refractory to medication  
Inclusion/exclusion criteria met 
 Enrollment to the study and informed consent obtained 
Screening and Pre-procedure (baseline) evaluation 
- Neurological and Otolaryngological Evaluation 
- MRV or CTV of the brain 
Stent placement across stenosis 
Post-procedure follow-up 
- Clinical exam: 1, 3, 6, 12, and 24 months after stenting 
- Audiometric assessment 3 months after stenting 
- MRV at 12 months after stenting 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 31 
 
 
PRINT OUT OF ELECTRONIC CASE REPORT FORM 
 
Name:  
 
 
 
 
 
Age:    
 
 
 
 
 
DOB:    
 
 
 
 
 
MRN:   
 
 
 
 
 
 
Tinnitus Grade: 
 
 
 
 
 
 
 
Tinnitus Location:  
 
 
 
 
 
 
 
 
 
 
Venous Dominance: 
 
 
 
 
 
 
 
 
 
 
Stenosis Location: 
 
 
 
 
 
 
 
 
 
 
Stenting Date:   
 
 
 
 
 
Stenting Result: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0
1
2
3
4
5
Right
Left
Bilateral
Right
Left
Codominant
Right
Left
Bilateral
no residual stenosis
residual stenosis <50%
residual stenosis >50%
technical failure

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 32 
 
Adverse Events: 
 
 
 
 
 
 
 
 
 
 
 
Description of Adverse Event    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tinnitus Grade: 
 
Post-Stent (1 month) 
 
 
 
 
 
 
Tinnitus Grade: 
 
Post-Stent (6 mos) 
 
 
 
 
 
 
Tinnitus Grade: 
 
Post-Stent (12 mos) 
 
 
 
 
 
 
Tinnitus Grade: 
 
Post-Stent (24 mos) 
 
 
 
 
 
 
Serious
Non-serious
Unexpected
0
1
2
3
4
5
0
1
2
3
4
5
0
1
2
3
4
5
0
1
2
3
4
5

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 33 
 
MRV (12 mos) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Any procedure-related adverse  
 
 
 
 
 
 
 
 
event after 24 months  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
no residual stenosis or thrombosis
in-stent stenosis <50%
in-stent stenosis >50%
new stenosis
stent thrombosis

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 34 
 
MANUFACTURING INFORMATION 
We (the sponsors) do not have access to the manufacturing information of the device. In a 
letter attached to this application, the manufacturer (Cordis Corporation) grants FDA the 
permission to reference the files used for the PMA#030047 in its review for the application 
for IDE# G090050.

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 35 
 
INVESTIGATOR INFORMATION 
All participating investigators and the monitor are listed below. All investigators have signed 
the agreement and no other investigator will be added until the agreement is signed. 
List of investigators 
Athos Patsalides MD MPH 
Assistant Professor of Radiology in Neurosurgery 
Division of Interventional Neuroradiology 
 
 
 
 
 
 
Weill Cornell Medical College 
 
 
 
 
 
 
525 East 68th Street, Box 99 
 
 
 
 
 
 
New York, NY 10065 
 
 
 
 
 
 
Tel:  
212-746-2821 
 
 
 
 
 
 
Fax:  
212-746-8111 
 
 
 
 
 
 
atp9002@med.cornell.edu 
 
Maria Suurna MD 
 
 
 
Assistant Professor  
 
 
 
 
 
 
Department of Otolaryngology – Head & Neck Surgery 
 
 
 
 
 
 
Weill Cornell Medical College 
 
 
 
 
 
 
1305 York Avenue, 5th Floor 
 
 
 
 
 
 
New York, NY 10065 
 
 
 
 
 
 
Tel: 
646-962-9135 
 
 
 
 
 
 
Fax: 
646-962-0162 
 
 
 
 
 
 
mas9390@med.cornell.edu 
 
Kelly Hannsgen MSN NP  
 
 
Nurse Practitioner 
 
 
 
 
 
 
Department of Neurological Surgery 
 
 
 
 
 
 
Weill Cornell Medical College 
 
 
 
 
 
 
525 East 68th Street, Box 99 
 
 
 
 
 
 
New York, NY 10065 
 
 
 
 
 
 
Tel:  
212-746-2821 
 
 
 
 
 
 
Fax:  
212-746-8111 
 
 
 
 
 
 
kec9053@med.cornell.edu 
 
Xem Bui 
 
 
 
 
Research Coordinator 
 
 
 
 
 
 
Department of Neurological Surgery 
 
 
 
 
 
 
Weill Cornell Medical College 
 
 
 
 
 
 
525 East 68th Street, Box 99 
 
 
 
 
 
 
New York, NY 10065 
 
 
 
 
 
 
Tel:  
212-746-1788 
 
 
 
 
 
 
Fax:  
212-746-8111 
 
 
 
 
 
 
xeb2001@med.cornell.edu 
 
 
Relevant Experience 
Athos Patsalides, MD, MPH  
Dr. Patsalides has previously worked with the Cordis Precise Pro Rx Nitinol Stent System on 
another IDE protocol (IDE# G090050) at Weill Cornell Medical College and is thus experienced 
with the device and its use to treat venous sinus stenosis.  
 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 36 
 
Maria Suurna, MD, FACS  
Dr. Suurna has five years of experience as a board-certified otolaryngologist and extensive 
experience working with patients with pulsatile tinnitus during her time at the University of 
Cincinnati, NYU Langone Medical Center, and Weill Cornell Medical College.  
 
Kelly Hannsgen, MSN, FNP-C  
Mrs. Hannsgen has eight years of experience as a nurse at Good Samaritan Hospital and New 
York Presbyterian-Weill Cornell Medical College. She has assisted Dr. Patsalides with patients 
who have received stenting to treat venous sinus stenosis both during the procedure and for 
follow-up.  
 
Xem Bui  
Ms. Bui will be responsible for overseeing the coordination of the study and handling data 
collection, analysis, and all IRB-related matters. She has experience as a research 
coordinator for the Department of Neurological Surgery at Weill Cornell Medical College 
and various research assistant experience.  
 
Sample investigator’s agreement 
This is to certify that I agree to participate in the investigation titled “Venous sinus stenting 
to treat intractable pulsatile tinnitus caused by venous sinus stenosis”. I will conduct the 
investigation in accordance with the agreement, the investigational plan, Part 812 and other 
applicable FDA regulations and conditions of approval imposed by the reviewing IRB and 
FDA. I will supervise all testing of the device involving human subjects and ensure that the 
requirements for obtaining informed consent are met. I have no financial interest to disclose 
regarding this study, and I will provide sufficient, accurate financial disclosure information, 
and update information if any relevant changes occur during the investigation and for one 
year following the completion of the study. 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 37 
 
IRB INFORMATION 
All parts of the study will be conducted at New York Presbyterian Hospital/ Weill Cornell 
Medical College and there will be no other institution involved in this study. Thus, only the 
IRB at Weill Cornell Medical College will review the investigation, pending IDE approval 
by the FDA. The investigation has not been reviewed by the IRB yet. 
 
Chairperson at Weill Cornell Medical College IRB: 
Mary Simmerling, Ph.D. 
Assistant Dean, Research Integrity 
Office of Research Integrity 
Location: 1300 York Avenue, Box #89 
New York, NY 10065 
P: (646) 962-8200 
E: mcs2006@med.cornell.edu 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 38 
 
SALES INFORMATION 
 
The device will not be sold or commercialized. 
 

Venous sinus stenting to treat intractable pulsatile tinnitus caused by venous sinus stenosis 
Updated IDE; May 12, 2017, Page: 39 
 
LABELING 
 
We will use the standard device labeling as approved by the FDA for carotid stenting.