Sinai Vein Stent Registry

NCT02600936 | Recruiting DMC FDA Device

• 1 other identifier: GCO 14-1497
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

venous outflow obstruction; peripheral venous disease; vein stent; Wallstent; registry; May Thurner

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• major adverse event occurrence

  30 day

• reintervention rate

  12 month

• Venous clinical severity score (VCSS)

  1 year

• VCSS

  3 years

• VCSS

  5 years

Study Arms (1)

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

Interventions

vein stent placement DEVICE

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.

Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Windsor Ting: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 14603188 BACKGROUND

• 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.

  PMID: 17980284 BACKGROUND

• 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.

  PMID: 22342482 BACKGROUND

• 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.

  PMID: 23558660 BACKGROUND

• 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.

  PMID: 24632315 BACKGROUND

Study Officials

• Windsor Ting, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah McCracken

CONTACT

2122418708; sarah.mccracken@mountsinai.org

Windsor Ting, MD

CONTACT

212-241-5393; windsor.ting@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 9, 2015
• Study Start: July 2, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (1)