Sinai Vein Stent Registry

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 Overview

• Status: Recruiting
• Conditions: Peripheral Venous Outflow Obstruction
• Intervention / Treatment: Device: vein stent placement

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Windsor Ting, MD; Phone Number: 45393 212-241-5393; Email: windsor.ting@mountsinai.org
• Study Contact Backup: Name: Sarah McCracken; Phone Number: 2122418708; Email: sarah.mccracken@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School Of Medicine At Mount Sinai
      • Contact: Windsor Ting, MD; Phone Number: 45393 212-241-5393; Email: windsor.ting@mountsinai.org
      • Contact: John Vullo; Phone Number: 212-241-8250; Email: John.Vullo2@mountsinai.org
      • Principal Investigator: Windsor Ting, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patient declines participation in the study.
• Confirmed ipsilateral acute DVT of the iliac vein.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Registry; A retrospective and prospectively maintained registry of patients who have undergone or will undergo vein stent placement for proximal venous outflow obstruction	Device: vein stent placement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 month
stent occlusion	occlusion of any stent segment, either the entire stent or any segment of the implanted stent	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 day
reintervention rate	estimated at 10%.	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.	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.	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.	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)	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)	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)	5 years

Collaborators and Investigators

• Sponsor: Windsor Ting
• Investigators: Principal Investigator: Windsor Ting, MD, Icahn School Of Medicine At Mount Sinai

Publications and helpful links

General 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.
• Neglen 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.
• Ye 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.
• O'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.
• Raju 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (Estimated): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: registry; venous outflow obstruction; peripheral venous disease; vein stent; Wallstent; May Thurner
• Other Study ID Numbers: GCO 14-1497

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes