BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease (NCT02655887) | Clinical Trial Compass
CompletedNot Applicable
BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
United States, Australia, Germany170 participantsStarted 2016-06-15
Plain-language summary
The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease.
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
. The subject provides written informed consent using an Informed Consent Form approved by Ethics Committee/ Institutional Review Board for the site.
. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
. The subject is a male or non-pregnant female ≥ 18 years old with an expected lifespan sufficient to allow for completion of all study procedures.
. The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral "venous segments".
. The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral venous segments(Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) "C" ≥ 3 or VCSS pain score of ≥ 2).
. The subject is able and willing to comply with any required medication regimen.
. The reference vessel diameters are between 7mm and 19 mm.
Exclusion criteria
. Subject is unable or unwilling to provide written informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
. Subject is or plans to become pregnant during the study.
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
Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure
Timeframe: 12 months post-index procedure
2
Number of Participants With Freedom From Major Adverse Events (MAEs)
. Subject has contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof and does not meet the venous outflow obstruction requirement or has a malignant obstruction.
. The subject is asymptomatic, has a CEAP "C" \<3, or a VCSS pain score of \<2.
. The subject has a venous obstruction that extends into the inferior vena cava (IVC) or below the level of the lesser trochanter.
. The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
. The subject has a known allergy or sensitivity to Nickel or Titanium or intolerance to antiplatelet, anticoagulant or thrombolytic medications medications required per the protocol
. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.