VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center, single arm, non-randomized study to define safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled. Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170 pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period is 36 months.

Detailed Description
-----------------
The objective of this prospective study is to assess the safety and efficacy of the Veniti Vici™ Venous Stent System in achieving patency of the target venous lesion in patients who present with clinically significant chronic non-malignant obstruction of the iliofemoral venous outflow tract.

Official Title
-----------------
VIRTUS Safety and Efficacy of the Veniti Vici™ Venous Stent System (Veniti, Inc.) When Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous Segment

Conditions
-----------------
Chronic Venous Disorder, Venous Outflow Obstruction, Symptomatic Venous Outflow Obstruction of Iliofemoral Vein

Intervention / Treatment
-----------------
* Device: Veniti Vici™ Venous Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Pre-Procedure Criteria: Age ≥ 18 years Willing and capable of complying with all follow-up evaluations at the specified times Able and willing to provide written informed consent prior to study-specific procedures Presence of unilateral, clinically significant, chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a ≥50% reduction in target vessel lumen diameter (to be measured by venogram during procedure) Clinically significant venous obstruction defined as meeting at least one of the following clinical indicators: Clinical severity class of CEAP classification ≥3 VCSS Pain Score ≥2 Negative pregnancy test in females of child-bearing potential Intention to stent the target lesion only with the Veniti Vici Venous Stent Exclusion Criteria - Pre-Procedure Criteria: Presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment. Venous obstruction that extends into the inferior vena cava (IVC) Contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof with planned treatment within 30 days after subject enrollment Life expectancy <12 months Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study Uncontrolled or active coagulopathy OR known, uncorrectable bleeding diathesis with the following definitions: Uncorrected INR ≥2.0 or aPTT ≥1.5 X normal local lab value Platelet count <80,000 Uncorrected hemoglobin of ≤ 9 g/dL Patients with an estimated glomerular filtration rate (eGFR) <30 mL/min. In patients with diabetes mellitus, eGFR <45 mL/min. Known hypersensitivity to nickel or titanium Contrast agent allergy that cannot be managed adequately with pre-medication Intended concurrent thrombolysis or thrombectomy procedure OR intended or planned (within 30 days) adjuvant procedure such as creation of temporary arteriovenous fistula, placement of IVC filter, endovenectomy or saphenous vein ablation Current or recent (within 30 days) active participation in another drug or device clinical trial (Participation in observational studies is acceptable.) Patient judged to be a poor candidate by the primary investigator Patients who have had any prior surgical or endovascular intervention of the target vessel [Note: Patients who have had catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 3 month (90 days) prior to the VIRTUS index procedure may be included in the trial.] Exclusion Criteria - Intra-Procedural Criteria: Patients in whom the lesions cannot be traversed with a guide wire. Patients where the obstruction extends into the inferior vena cava or below the level of the lesser trochanter. Patients whose vein diameters are not within limits stated in current Instructions for Use as determined by venogram. Patients who do not meet the venogram binary stenosis definition, as determined by the treating physician.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Thirty (30) patients will be enrolled at approximately 7 centers (feasibility cohort). These patients will not be included in the pivotal study population, but will be evaluated separately for the primary safety and efficacy endpoints as well as for all secondary endpoints. When these 30 feasibility patients have completed their 30-day follow-up, a Data Safety Monitoring Board (DSMB) will review the safety data and will determine if the study can proceed with enrollment of the 170 pivotal subjects.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VICI Stent Implantation - Feasibility<br>Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Device: Veniti Vici™ Venous Stent System<br> <br> |
| Experimental: VICI Stent Implantation - Pivotal<br>Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Device: Veniti Vici™ Venous Stent System<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Adverse Events (MAE) | The primary safety endpoint for this study will be a composite endpoint of any major adverse event (MAE) within 30 days, as adjudicated by a Clinical Events Committee. | 30 days | 
| Percentage of Participants That Demonstrated Primary Patency | The primary effectiveness endpoint is the primary patency rate at 12 months post-intervention, defined as freedom from occlusion by thrombosis, freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency, and freedom from in-stent stenosis more than 50% by venogram. | 12 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Improvement in Venous Clinical Severity Score (VCSS) | The secondary effectiveness endpoint for this study will be a binary response variable based on an improvement in Venous Clinical Severity Score (VCSS) by at least 50% at 12 months post-intervention. VCSS measures 10 clinical attributes of venous disease (Pain, Varicose Veins, Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3). | 12 months post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iliofemoral vein, venous, venous obstruction