BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, multi-center, non-randomized, single-arm clinical study of the VENOVO ™ Venous Stent for the treatment of iliofemoral occlusive disease. The study will be conducted at a maximum of 35 investigational sites (sites) in the United States, and Europe and Australia/New Zealand. Enrollment will continue until a maximum of one hundred seventy (170) subjects are treated with the VENOVO™ Venous Stent, which is an estimated three-hundred forty (340) consecutive subjects in a non-randomized fashion. It is assumed that approximately 50% of the treated subjects will be U.S. subjects. Clinical follow-up for all treated subjects will be performed at hospital discharge, 30-days, and 6-, 12-, 24-, and 36-months post-index procedure.

Official Title
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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
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Peripheral Vascular Disease, Venous Disease, Iliofemoral Occlusive Disease, May-Thurner Syndrome

Intervention / Treatment
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* Device: VENOVO™ Venous Stent


Participation Criteria
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Eligibility Criteria
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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. 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. The subject has any planned surgical interventions within 30 days prior to, or within 30 days after the planned study procedure. The subject has a lesion or occlusion which cannot be traversed with a guidewire. The subject has had prior stenting in the target vessel. The subject has iliofemoral venous segments unsuitable for treatment with available sizes of study devices. The subject has another medical condition, which 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 completion of study procedures and follow ups. The subject is currently participating in an investigational drug, biologic, or another device study. The subject is currently on dialysis or has a serum creatinine ≥2.5mg/dl.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VENOVO™ Venous Stent.<br>Implant of the VENOVO™ Venous Stent | Device: VENOVO™ Venous Stent<br>* VENOVO™ Venous stent placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure | Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis > 50% as measured by Duplex Ultrasound (DUS). Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful. | 12 months post-index procedure | 
| Number of Participants With Freedom From Major Adverse Events (MAEs) | Freedom from major adverse events (MAEs) defined as: Target Vessel Revascularization; Device and/or procedure related death; Major amputation of target limb; Pulmonary Embolism which is clinically important; Vascular injury requiring surgical/endovascular intervention; Embolization /migration of stent; Device or procedure related acute DVT involving the treated limb. Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful. | 30 days post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months | The Venous Clinical Severity Score (VCSS) system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration. and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 means absent, 1 means mild, 2 means moderate and 3 means severe. Total VCSS is the sum of all VCSS assessment scores from categories for a given time point. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for Intent-to-Treat (ITT) subjects. Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline. | Evaluation at 12 months post-index procedure | 
| Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months | The Quality of Life (QoL) assessment of Chronic Venous Insufficiency Questionnaire (CIVIC-20) is a 20-item questionnaire which provides a global index and an outline of 4 QoL dimensions - pain (4 items), physical (4 items), psychological (9 items) and social (4 items). Items are scored on a scale from 1 to 5. A low score corresponds to greater patient comfort. Total CIVIQ-20 score is the sum of all 20-item scores The score of each dimension was obtained by adding up the scores of each constituent item within that dimension. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for evaluable ITT subjects. Lower values represent a better outcome, that is, a better QoL than that experienced at baseline. | Evaluation at 12 months post-index procedure | 
| Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure | Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification is a system that describes a doctor's physical exam findings for vein problem(s), the cause of the problem(s), the location in the leg, and the mechanism responsible for the manifestation of the vein problem. For Clinical classification, the clinical components indicates disease severity, ranging from none (0 points) to active ulcers (6 points).For each category of Etiology, Anatomy, and Pathophysiology classifications, at each time point, frequency of each category is reported. Subsequent clinical study reports will present CEAP at 24 and 36-months follow-up. Changes from baseline measures to given time points are presented. Lower mean scores represent an improvement from baseline measure. | Evaluation through 30 day, 6 months and 12 months post index procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success | Acute technical success is defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator. | At time of Index Procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects) | Technical success is defined as no major adverse events experienced between index procedure and discharge | Less than 30 days post index procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects) | Lesion Success is defined as the attainment of less or equal to 50% residual stenosis at the conclusion of the index procedure. | At the conclusion of index procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects) | Freedom from Target Lesion Revascularization (TLR) through 30 days is specific to the first revascularization procedure of the target lesion. | Evaluation throrugh 30 day, 6 months and 12 months post index procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects) | Freedom from Target Vessel Revascularization (TVR) is defined as the first revascularization procedure of the target vessel, as determined by an Independent Core Lab. Freedom from Target Lesion Revascularization (TLR) and Freedom from TVR results are the same through the 12 month analysis as all TLRs were also TVRs in this case. | Evaluation through 30 days, 6 months and 12 months post index procedure | 
| Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up | Stents were evaluated at the 12 month follow-up for fracture analysis. Evaluable ITT subjects are included in this analysis. | Evaluation at 12 months post-index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vernacular, Iliofemoral Occlusive Disease