Ensayos clínicos

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
  • Has a 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)
  • Has 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
  • Has the presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment
  • Venous obstruction that extends into the inferior vena cava
  • 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
  • Has uncontrolled or active coagulopathy 
  • Has 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
  • Has an estimated glomerular filtration rate (eGFR) <30 mL/min
    • In patients with diabetes mellitus, eGFR <45 mL/min
  • Has known hypersensitivity to nickel or titanium
  • Has a contrast agent allergy that cannot be managed adequately with pre-medication
  • Will have intended concurrent thrombolysis or thrombectomy procedure 
  • Will have intended or planned (within 30 days) adjuvant procedure such as creation of temporary arteriovenous fistula, placement of IVC filter, endovenectomy or saphenous vein ablation
  • Has current or recent (within 30 days) active participation in another drug or device clinical trial
    • Participation in observational studies is acceptable
  • Is judged to be a poor candidate by the primary investigator
  • Has had any prior surgical or endovascular procedure of the target vessel 
    • Catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 3 month (90 days) prior to the VIRTUS index procedure is acceptable
•  Intra-Procedural Criteria
  • The lesions cannot be traversed with a guide wire
  • The obstruction extends into the inferior vena cava or below the level of the lesser trochanter
  • Vein diameters are not within limits stated in current Instructions for use as determined by venogram
  • Do not meet the venogram binary stenosis definition, as determined by the treating physician