Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial) (C-TRACT)
Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency
About this trial
This is an interventional treatment trial for Deep Vein Thrombosis focused on measuring deep vein thrombosis, superficial venous reflux, blood clot, post thrombotic syndrome, iliac vein obstruction
Eligibility Criteria
Inclusion Criteria: Subjects must meet BOTH of these Criteria
- 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.
Ipsilateral iliac vein obstruction documented within 12 months prior to screening by either:
- Occlusion or >50% 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: Subjects meeting any of these criteria will be excluded.
- 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.
Sites / Locations
- University of Alabama - Birmingham
- UCLA
- St. Joseph's Vascular InstituteRecruiting
- UCSFRecruiting
- Yale New Haven HospitalRecruiting
- Christiana Care HospitalRecruiting
- Piedmont Heart Institute
- Rush Medical CenterRecruiting
- University of ChicagoRecruiting
- NorthShore University Health SystemRecruiting
- Northwestern UniversityRecruiting
- AMITA Health Adventist
- Prairie Education and Research Cooperative
- Central DuPage
- Indiana UniversityRecruiting
- University of Iowa
- University of Maryland
- Mayo ClinicRecruiting
- University of Mississippi Medical CenterRecruiting
- Washington University School of MedicineRecruiting
- St. Elizabeth's Hospital
- New York University Medical Center
- New York Presbyterian-Weill Cornell MedicineRecruiting
- University of Vermont Health Network - CVPHRecruiting
- Staten Island Hospital
- Stony Brook Hospital
- University of North CarolinaRecruiting
- University Hospitals Cleveland Medical Center
- Jobst Vascular InstituteRecruiting
- University of Oklahoma
- Oregon Health & Sciences University
- University of Pennsylvania
- Thomas Jefferson University HospitalRecruiting
- Temple University
- University of Pittsburg
- Rhode Island Hospital
- University of Texas Health Science Center at Houston
- Intermountain Healthcare
- Inova Alexandria Hospital
- University of VirginiaRecruiting
- Gundersen Health SystemRecruiting
- Medical College of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Endovascular Therapy - Intervention
Non-Endovascular Therapy - Control
All subjects (EVT and No-EVT Arms) will receive optimal PTS care. At each Clinical Center, this will be supervised by a physician experienced in managing PTS. Subjects randomized to EVT will receive the following: imaging-guided iliac vein stent placement, and endovenous ablation of refluxing saphenous vein(s), if the patient has truncal reflux and is still symptomatic. optimal PTS therapy: medical and compression, lifestyle interventions and venous ulcer care
All subjects will receive optimal PTS care as noted above.