Status:
ACTIVE_NOT_RECRUITING
Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Ontario Clinical Oncology Group (OCOG)
Massachusetts General Hospital
Conditions:
Deep Vein Thrombosis
Venous Stasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and impro...
Detailed Description
The rationale for performing the C-TRACT Trial is based upon: 1. the debilitating life impact of DIO-PTS upon patients, as cited in the U.S. Surgeon General's 2008 Call to Action on DVT (95); 2. the ...
Eligibility Criteria
Inclusion
- 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 consent 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
- 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 \> 3.0, 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.
Key Trial Info
Start Date :
July 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2026
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT03250247
Start Date
July 2 2018
End Date
April 27 2026
Last Update
December 31 2025
Active Locations (29)
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1
St. Joseph's Vascular Institute
Orange, California, United States, 92868
2
UCSF
San Francisco, California, United States, 94143
3
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
4
Christiana Care Hospital
Newark, Delaware, United States, 19718