The BARD® VENOVO * Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease * an Assessment for Effectiveness and Safety (VERNACULAR)
- Conditions
- Iliofemoral Occlusive Disease10003216
- Registration Number
- NL-OMON47346
- Lead Sponsor
- C. R Bard
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
1. The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) / Institutional Review Board (IRB) for the site.
2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
3. 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. Female subjects of childbearing potential must have a negative pregnancy test (urine or blood) within 14 days prior to the index procedure.
4. The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral *venous segments* (unilateral obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof) of * 50% as determined by catheter contrast venography.
5. The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral venous segments with a Clinical-Etiology-Anatomic-Pathophysiologic Score CEAP *C* * 3 or a Venous Clinical Severity Score VCSS pain score of * 2.
6. The subject is able and willing to comply with any required medication regimen.
7. The reference vessel diameter(s) (RVD) is (are) between 7mm and 19mm as determined by the Investigator*s visual estimate.
1. The 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. ;2. The subject is or plans to become pregnant during the study.
3. The 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 as
determined by the treating Investigator or the target vessel has a
malignant obstruction.
4. The subject is asymptomatic, has a CEAP *C* <3, or a VCSS pain
score of <2.
5. The subject has a venous obstruction that extends into the inferior vena
cava (IVC) or below the level of the lesser trochanter.
6. The subject has a known uncorrectable bleeding diathesis or active
coagulopathy.
7. The subject has a known allergy or sensitivity to Nickel or Titanium or
has intolerance to antiplatelet, anticoagulant or thrombolytic
medications required per the protocol
8. The subject has a known allergy or sensitivity to contrast media, which
cannot be adequately pre-medicated.
9. The subject has any planned surgical interventions (other than pre-
stenting procedures of thrombolysis, thrombectomy, and/or vena cava
filter placement in patients at high risk for pulmonary embolism)
within 30 days prior to, or within 30 days after the planned study
procedure.
10.The subject has a lesion(s) or occlusion(s) which cannot be traversed
with a guidewire.
11.The subject has had prior stenting in the target vessel.
12.The subject has iliofemoral venous segments unsuitable for treatment
with available sizes of study devices.
13.The subject has another medical condition, which, in the opinion of
the Investigator, may cause him/her to be non-compliant with the
protocol, confound the data interpretation, or is associated with a life
expectancy insufficient to allow for the completion of study
procedures and follow-up.
14.The subject is currently participating in an investigational drug,
biologic, or another device study for which the investigational
treatment has not ended. Studies requiring extended follow-up for
products that are now commercially available are not considered
investigational studies.
15.The subject is currently on dialysis or has a serum creatinine * 2.5
mg/dl.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety:<br /><br>Freedom from Major Adverse Events (MAEs) through 30 days<br /><br>Defined as the following:<br /><br>* Device and/or procedure related death<br /><br>* Major amputation of target limb<br /><br>* Pulmonary Embolism which is clinically important (symptomatic with chest<br /><br>pain, hemoptysis, dyspnea, hypoxia, etc.)<br /><br>* Target Vessel Revascularization (TVR)<br /><br>* Vascular injury requiring surgical/endovascular intervention<br /><br>* Embolization/migration of stent<br /><br>* Device or procedure related acute DVT involving the treated limb<br /><br><br /><br>Efficacy:<br /><br>Primary Patency rate at 12 months defined as<br /><br>Freedom from TVR; freedom from thrombus occlusion and stenosis > 50% as<br /><br>measured by DUS. Note: Venography will be used only if investigator cannot<br /><br>successfully measure endpoint by DUS or if the investigator deems there is<br /><br>clinical need to perform invasive venography.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Evaluation of VCSS Scores at 30 days, 6, 12, 24, and 36 months Quality of<br /><br>Life Questionnaire (QOL) at 30 days, 6, 12, 24, and 36 months<br /><br>* Evaluation of CEAP Scores at 30 days, 6, 12, 24, and 36 months<br /><br>* Acute Procedure Success<br /><br>* Lesion Success<br /><br>* Acute Technical Success<br /><br>* Freedom From Target Lesion Revascularization (TLR) at 30 days 6, 24, 36<br /><br>months<br /><br>* Freedom From Target Vessel Revascularization (TVR) at 30 days, 6, 24, 36<br /><br>months<br /><br>* Primary Patency at 24, 36 months<br /><br>* X-ray analysis for stent fracture at 12, 24, and 36 months </p><br>