Peripheral Venous Outflow ObstructionNCT02600936
Sinai Vein Stent Registry
An observational study of Peripheral Venous Outflow Obstruction, run by Windsor Ting at 1 site in United States.
Trial summary
The Sinai Vein Stent Registry aims to establish and maintain a registry of patients who have undergone a vein stent placement procedure at The Mount Sinai Medical Center. The purpose of this study is to monitor and evaluate the long-term outcomes of venous stents placed to treat venous outflow obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Venous Outflow Obstruction
- What is being tested?
- vein stent placement
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2019to 31 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient has undergone or will undergo vein stent placement for proximal venous outflow obstruction in the ilio-femoral vein, inferior vena cava, subclavian vein, brachiocephalic vein, or superior vena cava.
Who may be able to join
- Patient is 18 years of age or older.
- Patient has undergone or will undergo vein stent placement for proximal venous outflow obstruction in the ilio-femoral vein, inferior vena cava, subclavian vein, brachiocephalic vein, or superior vena cava.
Who cannot join
- Patient declines participation in the study.
- Confirmed ipsilateral acute DVT of the iliac vein.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
John Vullo, 212-241-8250, John.Vullo2@mountsinai.org
Windsor Ting, MD, 212-241-5393 ext. 45393, windsor.ting@mountsinai.org
About this study
The Sinai Vein Stent Registry aims to establish and maintain a registry of patients who have undergone a vein stent placement procedure at The Mount Sinai Medical Center. The purpose of this study is to monitor and evaluate the long-term outcomes of venous stents placed to treat venous outflow obstruction. Outcome variables that will be assessed are: patency rate, reintervention rate, occurrence of any complications, clinical improvement, and quality of life. Venous outflow obstruction is defined as a stenosis and/or occlusion seen primarily in the ilio-femoral vein and inferior vena cava, and infrequently in the subclavian vein, brachiocephalic vein, or superior vena cava. While vein stent placement procedures are currently being performed in the United States, using stents which are commercially available and FDA-approved for use in arterial interventions, at this time there are no stents that are FDA-approved for use in veins. The placement of stents in veins holds tremendous promise as a treatment for venous outflow obstruction, but review of current literature has showed a paucity of published data on the long-term outcomes of this treatment.
The study is composed of two arms, a retrospective arm and a prospective arm. Any patient over the age of 18 who has undergone or is scheduled to undergo a vein stent placement procedure is eligible for this study. A HIPAA waiver and waiver of informed consent are being requested for the retrospective arm for patients who have undergone a vein stent placement procedure from January 1st 2012 to date of study onset, as it is not possible to contact all patients in the retrospective arm (i.e., lost to follow-up, no longer follows-up with a study physician). This study is only interested in the collection and analysis of data; the clinical care and outcomes of research subjects will not be affected by their participation in this study.
An IDE application has been submitted to the FDA for use of the Wallstent™ (manufactured by Boston Scientific, Inc.) in veins as treatment for venous outflow obstruction. The primary stents being used as treatment for venous outflow obstruction at Mount Sinai is the Wallstent™, mainly due to the fact that only Wallstents™ are available in the appropriate sizes to be used in veins. In rare occasions or exceptional circumstances, a smaller self-expanding nitinol stent may be used. Due to the extremely rare frequency of stents other than Wallstents™ being used and the impracticality (if not impossibility) of obtaining IDEs for all other stents, the investigators believe it is appropriate to exclude usage of these stents from the study data. To confirm, the purpose of this study is to monitor and evaluate long-term outcomes of the venous stents/the vein stent placement procedure, not specifically the Wallstent™ itself.
- Conditions
- Peripheral Venous Outflow Obstruction
- Being tested
- vein stent placement
- Keywords
- venous outflow obstruction, peripheral venous disease, vein stent, Wallstent, registry, May Thurner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vein stent placementDevice
Venous outflow obstruction will be treated by the placement of a stent to keep the vein open. This procedure is a minimally invasive endovascular treatment.
| Study group | Role | What they receive |
|---|---|---|
| Registry | A retrospective and prospectively maintained registry of patients who have undergone or will undergo vein stent placement for proximal venous outflow obstruction Receives: Device: vein stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
lumen area of stent
change in lumen area of 50% or greater in diseased segment compared to maximal reference lumen area of stent as measured by venogram and/or intravascular ultrasound (IVUS)
Measured: 12 month
stent occlusion
occlusion of any stent segment, either the entire stent or any segment of the implanted stent
Measured: 12 month
Secondary outcomes (8)
major adverse event occurrence
performance goal estimated at 1% or less. Major adverse events are defined as: 1) Death, by any cause, 2) Bleeding requiring surgical or endovascular intervention or blood transfusion >= 2 units that is considered probably or definitely related to the index procedure or device, 3) Vascular injury requiring surgical/endovascular intervention, 4) Clinically significant pulmonary embolism requiring anticoagulation and/or thrombolysis, 5) Embolization/migration of stent
Measured: 30 day
reintervention rate
estimated at 10%.
Measured: 12 month
Venous clinical severity score (VCSS)
The VCSS was developed from elements of the CEAP classification (clinical grade, etiology, anatomy, pathophysiology), which is the worldwide standard for describing the clinical features of chronic venous disease. Components rated 0-3, with 3 being severe.
Measured: 1 year
VCSS
The VCSS was developed from elements of the CEAP classification (clinical grade, etiology, anatomy, pathophysiology), which is the worldwide standard for describing the clinical features of chronic venous disease. Components rated 0-3, with 3 being severe.
Measured: 3 years
VCSS
The VCSS was developed from elements of the CEAP classification (clinical grade, etiology, anatomy, pathophysiology), which is the worldwide standard for describing the clinical features of chronic venous disease. Components rated 0-3, with 3 being severe.
Measured: 5 years
CEAP score
Assess clinical improvement with CEAP, scored from 1-6 with 6 being severe (C- clinical manifestation E- etiologic factors A- anatomic distribution P- pathophysiologic dysfunction)
Measured: 1 year
CEAP score
Assess clinical improvement with CEAP, scored from 1-6 with 6 being severe (C- clinical manifestation E- etiologic factors A- anatomic distribution P- pathophysiologic dysfunction)
Measured: 3 year
CEAP score
Assess clinical improvement with CEAP, scored from 1-6 with 6 being severe (C- clinical manifestation E- etiologic factors A- anatomic distribution P- pathophysiologic dysfunction)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study start2 Jul 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Venous Outflow ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Windsor Ting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Windsor Ting, Icahn School of Medicine at Mount Sinai
- Investigators
- Windsor Ting, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600936
- Sponsor's protocol ID
- GCO 14-1497
- Status last verified
- May 2026
- First submitted
- 6 Nov 2015
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Neglen P, Thrasher TL, Raju S. Venous outflow obstruction: An underestimated contributor to chronic venous disease. J Vasc Surg. 2003 Nov;38(5):879-85. doi: 10.1016/s0741-5214(03)01020-6.
PubMed 14603188Neglen P, Hollis KC, Olivier J, Raju S. Stenting of the venous outflow in chronic venous disease: long-term stent-related outcome, clinical, and hemodynamic result. J Vasc Surg. 2007 Nov;46(5):979-990. doi: 10.1016/j.jvs.2007.06.046.
PubMed 17980284Ye K, Lu X, Li W, Huang Y, Huang X, Lu M, Jiang M. Long-term outcomes of stent placement for symptomatic nonthrombotic iliac vein compression lesions in chronic venous disease. J Vasc Interv Radiol. 2012 Apr;23(4):497-502. doi: 10.1016/j.jvir.2011.12.021. Epub 2012 Feb 17.
PubMed 22342482O'Sullivan GJ, Sheehan J, Lohan D, McCann-Brown JA. Iliofemoral venous stenting extending into the femoral region: initial clinical experience with the purpose-designed Zilver Vena stent. J Cardiovasc Surg (Torino). 2013 Apr;54(2):255-61.
PubMed 23558660Raju S, Ward M Jr, Kirk O. A modification of iliac vein stent technique. Ann Vasc Surg. 2014 Aug;28(6):1485-92. doi: 10.1016/j.avsg.2014.02.026. Epub 2014 Mar 12.
PubMed 24632315
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinai Vein Stent Registry
- ClinicalTrials.gov ID
- NCT02600936
- Acronym / sponsor ID
- GCO 14-1497
- Conditions
- Peripheral Venous Outflow Obstruction
- Keywords
- venous outflow obstruction, peripheral venous disease, vein stent, Wallstent, registry, May Thurner
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Windsor TingUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Sinai Vein Stent Registry aims to establish and maintain a registry of patients who have undergone a vein stent placement procedure at The Mount Sinai Medical Center. The purpose of this study is to monitor and evaluate the long-term outcomes of venous stents placed to treat venous outflow obstruction. Outcome variables that will be assessed are: patency rate, reintervention rate, occurrence of any complications, clinical improvement, and quality of life. Venous outflow obstruction is defined as a stenosis and/or occlusion seen primarily in the ilio-femoral vein and inferior vena cava, and infrequently in the subclavian vein, brachiocephalic vein, or superior vena cava. While vein stent placement procedures are currently being performed in the United States, using stents which are commercially available and FDA-approved for use in arterial interventions, at this time there are no stents that are FDA-approved for use in veins. The placement of stents in veins holds tremendous promise as a treatment for venous outflow obstruction, but review of current literature has showed a paucity of published data on the long-term outcomes of this treatment.
The study is composed of two arms, a retrospective arm and a prospective arm. Any patient over the age of 18 who has undergone or is scheduled to undergo a vein stent placement procedure is eligible for this study. A HIPAA waiver and waiver of informed consent are being requested for the retrospective arm for patients who have undergone a vein stent placement procedure from January 1st 2012 to date of study onset, as it is not possible to contact all patients in the retrospective arm (i.e., lost to follow-up, no longer follows-up with a study physician). This study is only interested in the collection and analysis of data; the clinical care and outcomes of research subjects will not be affected by their participation in this study.
An IDE application has been submitted to the FDA for use of the Wallstent™ (manufactured by Boston Scientific, Inc.) in veins as treatment for venous outflow obstruction. The primary stents being used as treatment for venous outflow obstruction at Mount Sinai is the Wallstent™, mainly due to the fact that only Wallstents™ are available in the appropriate sizes to be used in veins. In rare occasions or exceptional circumstances, a smaller self-expanding nitinol stent may be used. Due to the extremely rare frequency of stents other than Wallstents™ being used and the impracticality (if not impossibility) of obtaining IDEs for all other stents, the investigators believe it is appropriate to exclude usage of these stents from the study data. To confirm, the purpose of this study is to monitor and evaluate long-term outcomes of the venous stents/the vein stent placement procedure, not specifically the Wallstent™ itself.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry | – | Device: vein stent placementA retrospective and prospectively maintained registry of patients who have undergone or will undergo vein stent placement for proximal venous outflow obstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient has undergone or will undergo vein stent placement for proximal venous outflow obstruction in the ilio-femoral vein, inferior vena cava, subclavian vein, brachiocephalic vein, or superior vena cava.
Key inclusion criteria (2 listed)
- Patient is 18 years of age or older.
- Patient has undergone or will undergo vein stent placement for proximal venous outflow obstruction in the ilio-femoral vein, inferior vena cava, subclavian vein, brachiocephalic vein, or superior vena cava.
Key exclusion criteria (2 listed)
- Patient declines participation in the study.
- Confirmed ipsilateral acute DVT of the iliac vein.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vein stent placementVenous outflow obstruction will be treated by the placement of a stent to keep the vein open. This procedure is a minimally invasive endovascular treatment. | Device | Registry |
Primary outcome
lumen area of stent
Time frame: 12 month
change in lumen area of 50% or greater in diseased segment compared to maximal reference lumen area of stent as measured by venogram and/or intravascular ultrasound (IVUS)
stent occlusion
Time frame: 12 month
occlusion of any stent segment, either the entire stent or any segment of the implanted stent
8 secondary outcomes
major adverse event occurrence
Time frame: 30 day
reintervention rate
Time frame: 12 month
Venous clinical severity score (VCSS)
Time frame: 1 year
VCSS
Time frame: 3 years
VCSS
Time frame: 5 years
CEAP score
Time frame: 1 year
CEAP score
Time frame: 3 year
CEAP score
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 14603188Neglen P, Thrasher TL, Raju S. Venous outflow obstruction: An underestimated contributor to chronic venous disease. J Vasc Surg. 2003 Nov;38(5):879-85. doi: 10.1016/s0741-5214(03)01020-6.
- Background: PubMed 17980284Neglen P, Hollis KC, Olivier J, Raju S. Stenting of the venous outflow in chronic venous disease: long-term stent-related outcome, clinical, and hemodynamic result. J Vasc Surg. 2007 Nov;46(5):979-990. doi: 10.1016/j.jvs.2007.06.046.
- Background: PubMed 22342482Ye K, Lu X, Li W, Huang Y, Huang X, Lu M, Jiang M. Long-term outcomes of stent placement for symptomatic nonthrombotic iliac vein compression lesions in chronic venous disease. J Vasc Interv Radiol. 2012 Apr;23(4):497-502. doi: 10.1016/j.jvir.2011.12.021. Epub 2012 Feb 17.
- Background: PubMed 23558660O'Sullivan GJ, Sheehan J, Lohan D, McCann-Brown JA. Iliofemoral venous stenting extending into the femoral region: initial clinical experience with the purpose-designed Zilver Vena stent. J Cardiovasc Surg (Torino). 2013 Apr;54(2):255-61.
- Background: PubMed 24632315Raju S, Ward M Jr, Kirk O. A modification of iliac vein stent technique. Ann Vasc Surg. 2014 Aug;28(6):1485-92. doi: 10.1016/j.avsg.2014.02.026. Epub 2014 Mar 12.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Windsor Ting, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Venous Outflow Obstruction, run by Windsor Ting at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah McCracken (2122418708, sarah.mccracken@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lumen area of stent (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02600936, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.