Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent Sā¦ (NCT04580160) | Clinical Trial Compass
CompletedNot Applicable
Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
United States162 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 range18 Years
SexALL
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Inclusion criteria
ā. Males or non-pregnant, non-breastfeeding females ā„18 years of age at the time of consent
ā. Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
ā. 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
ā. Willing and capable of complying with all required follow-up visits
ā. Estimated life expectancy ā„1 year
ā. Subject is ambulatory (use of assistive walking device such as a cane or walker is acceptable)
ā. Body mass index (BMI) \<40
ā. 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
ā. Target limb symptoms caused by peripheral arterial disease
ā. 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.
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