Registry for patients with vein stent placement
Sinai Vein Stent Registry
This study is tracking patients who have received vein stents to see how well they work for improving blood flow and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02600936 on ClinicalTrials.gov |
What this trial studies
The Sinai Vein Stent Registry is designed to collect and analyze data from patients who have received vein stents at The Mount Sinai Medical Center. This observational study will track long-term outcomes related to the effectiveness of these stents in treating peripheral venous outflow obstruction. Key metrics such as patency rates, reintervention rates, complications, clinical improvements, and quality of life will be evaluated. The study aims to provide valuable insights into the use of vein stents, which are currently not FDA-approved for venous applications despite their use in arterial interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone or are scheduled for vein stent placement for proximal venous outflow obstruction.
Not a fit: Patients with confirmed acute deep vein thrombosis (DVT) of the iliac vein or those who decline participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of vein stent efficacy and improve treatment strategies for patients with venous outflow obstruction.
How similar studies have performed: While vein stent placement is being performed, this registry approach is novel as it aims to systematically evaluate long-term outcomes in a dedicated patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Windsor Ting, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Sarah McCracken
- Email: sarah.mccracken@mountsinai.org
- Phone: 2122418708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.