Clinical Trials

Inclusion Criteria:

• Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > 3 months duration in a leg with history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator.
• Ipsilateral iliac vein obstruction documented within 3 months prior to screening by either:
  • Occlusion or >50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS); or
  • Air plethysmography showing deep venous obstruction of the ipsilateral leg (reduced venous outflow fraction), and ultrasound showing echogenic material in the ipsilateral iliac vein and non-phasic continuous Doppler flow in the ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler flow in the contralateral CFV.

Exclusion Criteria:

• Age less than 18 years.
• Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned.
• Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician.
• Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein.
• Absence of PTS of at least moderate severity.
• Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented).
• Presence of open venous ulcer > 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg.
• Inability to tolerate endovascular procedure due to acute illness, or general health.
• Severe allergy to iodinated contrast refractory to steroid premedication.
• Known allergy to stent or catheter components.
• Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.05, or platelet count < 75,000/ml.
• Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min).
• Disseminated intravascular coagulation or other major bleeding diathesis.
• Pregnancy (positive pregnancy test).
• Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS.
• Inability to provide informed consent or to comply with study assessments.
  • Note:  patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/15/22. Questions regarding updates should be directed to the study team contact.