Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent S… (NCT04580160) | Clinical Trial Compass
CompletedNot Applicable
Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
United States, Poland162 participantsStarted 2020-11-30
Plain-language summary
This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to investigate the safety and efficacy of the Vesper DUO Venous Stent System as compared to a pre-defined performance goal (PG) established from published, peer reviewed scientific literature related to stenting of iliofemoral venous outflow obstructions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or non-pregnant, non-breastfeeding females ≥18 years of age at the time of consent
. Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to treatment and must use some form of contraception (abstinence is acceptable) throughout the time of clinical trial exit
. Willing and capable of complying with all required follow-up visits
. Estimated life expectancy ≥1 year
. Subject is ambulatory (use of assistive walking device such as a cane or walker is acceptable)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety - Number of Participants Free From Major Adverse Events (MAEs) at 30 Days
Timeframe: 30 days
2
Efficacy - Number of Participants With Primary Patency of Stented Segment at 12 Months
. Clinically significant symptomatic venous outflow obstruction in one iliofemoral venous segment (one limb) per subject, is indicated for venoplasty and stenting, and meets at least one of the following clinical indicators:
Exclusion criteria
. Target limb symptoms caused by peripheral arterial disease
. Presence of unresolved significant pulmonary embolism prior to use of the DUO Venous Stent System confirmed by chest CT. If subject has documented history of significant pulmonary embolism within the last 6 months, a chest CT is required to confirm significant pulmonary embolism is not currently present.
. Presence of IVC obstruction or target venous obstruction that extends into the IVC
. Presence of acute DVT located outside target limb
. Contralateral venous occlusive disease of the CFV, EIV, and/or CIV, with planned treatment ≤390 days after the index procedure
. Uncontrolled or active coagulopathy or known, uncorrectable bleeding diathesis
. Coagulopathy causing INR \>2 which is not amenable to medical treatment
. Platelet count \<50,000 cells/mm3 or \>1,000,000 cells/mm3 and/or White blood cell (WBC) \<3,000 cells/mm3 or \>12,500 cells/mm3