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 improve quality of life in patients with established disabling iliac-obstructive post thrombotic syndrome (DIO-PTS).
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 inability of existing therapies to prevent or alleviate most cases of DIO-PTS; 3. the role of iliac vein obstruction and saphenous reflux in causing the severe manifestations of DIO-PTS; 4. the ability of stent placement and endovenous ablation to eliminate obstruction and reflux, respectively, to reduce PTS severity, and to improve QOL in preliminary studies; 5. the risks, costs, and uncertainties of this novel but invasive strategy; 6. the lack of consensus on whether EVT should be used for DIO-PTS; 7. the motivation of our established investigator team to answer this critical clinical question. We will determine if EVT should be routinely used to treat DIO-PTS. If so, this finding will fundamentally change DIO-PTS practice towards more frequent use of EVT. If EVT proves ineffective or unsafe, this finding will reduce or eliminate the use of potentially risky and expensive procedures. 250 subjects with established DIO-PTS will be randomized in a 1:1 ratio to either EVT or No-EVT treatment groups. All participants will receive standard PTS therapy. Subjects will be enrolled over approximately 36 months in 20-40 U.S. Participants enrolled in C-TRACT protocol versions prior to 5.0 will be followed for 24 months. Subjects enrolled on protocol version 5.0 or after will be followed for 6 months. The study will take approximately 6 years to complete.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
225
US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram and intravascular ultrasound of CFV through infrarenal IVC. Iliac vein should be pre-dilated to at least 12 mm. Bare, self-expanding stents made of elgiloy or nitinol legally marketed in the US for any indication and that are at least 12 mm in diameter should be used to recanalize the entire diseased segment of vein. The use of devices \> 14 mm is highly recommended for the iliac vein and should be dilated to at least 14 mm, unless compelling patient factors dictate dilatation to a smaller diameter. Balloon angioplasty of inflow veins if needed to optimize inflow, per standard practice.
St. Joseph's Vascular Institute
Orange, California, United States
UCSF
San Francisco, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Christiana Care Hospital
Newark, Delaware, United States
Rush Medical Center
Chicago, Illinois, United States
University of Chicago
PTS Severity
"Venous Clinical Severity Scale (VCSS) score, adjusted for baseline"
Time frame: over 6 months follow-up
Venous quality of life
VEINES-QOL questionnaire
Time frame: 6 months
Gereric quality of life
Short-Form-36 survey, physical component score
Time frame: 6 months
Estimated calf volume
Measure calf length/diameter, formula for truncated cone
Time frame: 6 months
Presence of open ulcer
Blinded clinic assessment
Time frame: 6 months
PTS severity (secondary)
Villalta PTS Scale score
Time frame: 6 months
Major bleeding
Overt, requiring \> 2 units pRBC or critical location
Time frame: 6 months
Recurrent venous thrombeombolism
Objectively confirmed proximal DVT or PE
Time frame: 6 months
Death
All-cause mortality
Time frame: 6 months
Valvular reflux
Venous Segmental Disease Scale, reflux score
Time frame: 6 months
Venous obstruction
Venous Segmental Disease Scale, obstruction score
Time frame: 6 months
Venous quality of life
VEINES-QOL questionnaire
Time frame: 12 months
Gereric quality of life
Short-Form-36 survey, physical component score
Time frame: 12 months
PTS severity (remote)
Patient-Reported Villalta
Time frame: 12 months
Venous quality of life
VEINES-QOL questionnaire
Time frame: 18 months
Gereric quality of life
Short-Form-36 survey, physical component score
Time frame: 18 months
PTS severity (remote)
Patient-Reported Villalta
Time frame: 18 months
Venous quality of life
VEINES-QOL questionnaire
Time frame: 24 months
Gereric quality of life
Short-Form-36 survey, physical component score
Time frame: 24 months
PTS severity (remote)
Patient-Reported Villalta
Time frame: 24 months
Major bleeding
Overt, requiring \> 2 units pRBC or critical location
Time frame: 24 months
Recurrent venous thrombeombolism
Objectively confirmed proximal DVT or PE
Time frame: 24 months
Death Death
All-cause mortality
Time frame: 24 months
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Chicago, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
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