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 States170 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 range18 Years
SexALL
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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.
✕. 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.
✕
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)
. 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.