Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Aug 14, 2017

Keywords

ClinConnect Summary

The C-TRACT Trial is researching a treatment option for patients suffering from a condition called Post Thrombotic Syndrome (PTS), which often follows a deep vein thrombosis (DVT) in the leg. The study aims to see if a special procedure using image-guided therapy can help reduce the severity of PTS and improve the quality of life for individuals experiencing significant symptoms that limit their daily activities. To participate, patients must be aged 65 or older and have moderate to severe PTS, along with a specific blockage in the iliac vein of the affected leg.

Eligible participants can expect to undergo a procedure that aims to improve their symptoms, and the trial is currently recruiting individuals who meet the criteria. It's important to note that certain health conditions or recent medical events may prevent someone from joining the study, but those who initially don't qualify may be re-evaluated later. This trial could offer hope for those struggling with the effects of PTS and looking for relief from their symptoms.

Gender

ALL

Eligibility criteria

• • 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.