Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial) (C-TRACT)
S
Sabah D. Butty, MD
Primary Investigator
Overview
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) diseaseverity and improve quality of life in patients with established disabling iliac-obstructivehrombotic syndrome (DIO-PTS).
Description
The rationale for performing the C-TRACT Trial is based upon:
- 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);
- the inability of existing therapies to prevent or alleviate most cases of DIO-PTS;
- the role of iliac vein obstruction and saphenous reflux in causing the severeDIO-PTS;
- the ability of stent placement and endovenous ablation to eliminate obstruction andux, respectively, to reduce PTS severity, and to improve QOL in preliminary studies;
- the risks, costs, and uncertainties of this novel but invasive strategy;
- the lack of consensus on whether EVT should be used for DIO-PTS;
- 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 willundamentally change DIO-PTS practice towards more frequent use of EVT. If EVT provesve or unsafe, this finding will reduce or eliminate the use of potentially risky andve procedures.
374 subjects with established DIO-PTS will be randomized in a 1:1 ratio to either EVT orVT treatment groups. All participants will receive standard PTS therapy. Subjects will bed over approximately 36 months in 20-40 U.S. Clinical Centers, and followed for 24hs. The study will take approximately 6 years to complete.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency, Venous Leg Ulcer, Venous Reflux, Post Thrombotic Syndrome
-
Age: 18 Years
-
Gender: All
Inclusion Criteria: Subjects must meet BOTH of these Criteria
- Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease >= 3 months duration in a leg with history of DVT, as determined by the sitevestigator or a physician co-investigator; and b) substantial limitationdaily activities or work capacity due to venous symptoms or an open venous ulcer,he same investigator.
- Ipsilateral iliac vein obstruction documented within 12 months prior to screening byher
- Occlusion or >50% or = 50% stenosis of the iliac vein on venogram, CT venogram,R 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 inhe ipsilateral iliac vein and non-phasic continuous Doppler flow in thevein (CFV) in the presence of normal phasic Dopplerw 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 acuteDVT for which thrombolytic therapy is planned
- Lack of suitable inflow into the ipsilateral common femoral vein per the treatinghysician
- Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoralvein
- Absence of PTS of at least moderate severity
- Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1h) in the ipsilateral leg (if peripheral arterial disease is present or suspected,kle-brachial index should be obtained and documented)
- Presence of open venous ulcer > 50 cm2 area, suspicion for active ulcer infection, orvisualization 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-evaluatedubsequent occasion.
Updated on
03 May 2024.
Study ID: 201707130
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