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NCT02600936 · ClinicalTrials.gov registry record
Sinai Vein Stent Registry
A clinical trial of Peripheral Venous Outflow Obstruction, sponsored by Windsor Ting.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT02600936 is a study of Peripheral Venous Outflow Obstruction that is actively recruiting participants, run by Windsor Ting. The registered enrollment target is 1,000 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02600936, a study of Peripheral Venous Outflow Obstruction, is actively recruiting participants, sponsored by Windsor Ting.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
Study 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 b
Conditions Studied
Interventions
- DEVICE vein stent placement
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2016-01-01 |
| Est. Completion | 2026-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02600936
The ClinicalTrials.gov registry entry for NCT02600936 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Windsor Ting, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Peripheral Venous Outflow Obstruction appearing as the primary indexed condition, and to 1 intervention - of which vein stent placement is the first listed.
NCT02600936 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02600936 about?
NCT02600936 is a clinical study titled "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 obstr...
What is the current status of trial NCT02600936?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2016-01-01. Estimated completion is 2026-12-31.
What conditions does trial NCT02600936 study?
This clinical trial studies the following conditions: Peripheral Venous Outflow Obstruction.
What interventions are being tested in trial NCT02600936?
The interventions under investigation include: vein stent placement (DEVICE).
Who is sponsoring clinical trial NCT02600936?
This trial is sponsored by Windsor Ting, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02600936 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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