Using catheter-directed therapy to relieve chronic venous thrombosis symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of image-guided endovascular therapy (EVT) in reducing the severity of Post Thrombotic Syndrome (PTS) and improving the quality of life for patients suffering from disabling iliac-obstructive PTS. A total of 250 participants will be randomly assigned to receive either EVT or standard treatment without EVT, with all subjects receiving standard PTS therapy. The study will assess the impact of EVT on symptoms and daily activities over a follow-up period of up to 24 months. The findings could significantly influence clinical practices regarding the treatment of DIO-PTS.

Why it matters

Who can join: the full rules

Inclusion Criteria: Subjects must meet BOTH of these Criteria

1. Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease \> or = 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.
2. Ipsilateral iliac vein obstruction documented within 12 months prior to screening by either:

   1. Occlusion or \>50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or
   2. 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: Subjects meeting any of these criteria will be excluded.

1. Age less than 18 years
2. Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned
3. Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
4. Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein
5. Absence of PTS of at least moderate severity
6. 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)
7. 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
8. Inability to tolerate endovascular procedure due to acute illness, or general health
9. Severe allergy to iodinated contrast refractory to steroid premedication
10. Known allergy to stent or catheter components
11. Hemoglobin \< 8.0 g/dl, uncorrectable INR \> 3.05, or platelet count \< 75,000/ml
12. Severe renal impairment (on chronic dialysis or estimated GFR \< 30 ml/min)
13. Disseminated intravascular coagulation or other major bleeding diathesis
14. Pregnancy (positive pregnancy test)
15. Life-expectancy \< 6 months or chronically non-ambulatory for reasons other than PTS
16. 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.

Where it's running

• St. Joseph's Vascular Institute
  Orange, California, United States Recruiting
• UCSF
  San Francisco, California, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Christiana Care Hospital
  Newark, Delaware, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• NorthShore University Health System
  Evanston, Illinois, United States Recruiting

Study contacts

• Principal investigator: Suresh Vedantham, M.D. — Clinical Coordinating Center at Washington University School of Medicine
• Study coordinator: Mary Clare Derfler, RN MSN
• Email: Derflerm@wustl.edu
• Phone: 314-973-0739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.