VIRTUS - OUS 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

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Age >=18 years
2. Willing and capable of complying with all follow-up evaluations at the specified times
3. Able and willing to provide written informed consent prior to study specific procedures
4. 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 as measured by venogram
5. Clinically significant venous obstruction defined as meeting at least one of the following clinical indicators:
• Clinical severity class of CEAP classification >=3 (See Appendix 4.)
• VCSS Pain Score >=2 (See Appendix 7.)
6. Negative pregnancy test in females of child-bearing potential
7. Intention to stent the target lesion only with the Veniti Vici* Venous Stent

Exclusion Criteria

1. Presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment.
2. Venous obstruction that extends into the inferior vena cava
3. 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
4. Life expectancy <12 months
5. Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study
6. Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis
a. Uncorrected INR >=2.0 or aPTT >=1.5 X normal local lab value
b. Platelet count <100,000
c. Anti-platelet therapy except for ASA (patients on clopidogrel, prasugrel who cannot discontinue for seven days prior to the procedure are excluded)
7. Uncorrected hemoglobin of <=9 g/dL
8. Patients with an estimated glomerular filtration rate (eGFR) <30 mL/min
9. Known hypersensitivity to nickel or titanium
10. Contrast agent allergy that cannot be managed adequately with pre-medication
11. Intended concurrent thrombolysis or thrombectomy procedure OR intended or planned (within 30 days) adjuvant procedure such as creation of temporary AV fistula, placement of IVC filter, endovenectomy or saphenous vein ablation
12. Current or recent (within 30 days) active participation in another drug or device clinical trial
13. Patient judged to be a poor candidate by the primary investigator
14. Patient who does not consent to either the study treatment or study procedures, including follow-up visits
15. Patients who have had any prior surgical or endovascular procedure of the target vessel;Intra-procedural
1. Patients in whom the lesions cannot be traversed with a guide wire. These patients will not be enrolled and will not count against the study sample size.
2. Patients where the obstruction extends into the inferior vena cava. These patients will not be enrolled and will not count against the study sample size.
3. Patients whose vein diameters are not within limits stated in current Instructions for Use as determined by venogram. These patients will not be enrolled and will not count against the study sample size.
4. Patients who do not meet the venogram binary stenosis definition above, as determined by the treating physician.