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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    374
  • sponsor
    Washington University School of Medicine
Updated on 24 June 2021
stenosis
clot
blood clot
venous stasis
venous thrombosis
venous disease
post thrombotic syndrome
dvts

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 improve quality of life in patients with established disabling iliac-obstructive post thrombotic syndrome (DIO-PTS).

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 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.

374 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. Clinical Centers, and followed for 24 months. The study will take approximately 6 years to complete.

Details
Condition Varicose Ulcer, Venous Thrombosis, Vascular Diseases, Venous stasis, Venous Insufficiency, Thrombosis, Blood Clots, Venous Reflux, Deep Vein Thrombosis, deep venous thrombosis of lower extremity, venous ulcers, venous ulcer, deep venous thrombosis, post thrombotic syndrome
Treatment Stents
Clinical Study IdentifierNCT03250247
SponsorWashington University School of Medicine
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > 3 months duration in a leg with history of DVT; and b) either a Venous Clinical Severity Score (VCSS) > 8 or a Villalta PTS Scale score > 10 or an open venous ulcer); and
Ipsilateral iliac vein obstruction documented within 3 months prior to screening by
either
Occlusion 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

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
Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
Documented obstruction (occlusion or > 50% diameter stenosis) of an IVC filter
Chronic arterial limb ischemia (ankle-brachial index < 0.5)
Presence of open venous ulcer > 50 cm2 area, or suspicion for active ulcer infection 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 > 3.5, or platelet count < 50,000/ml
Severe renal impairment (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 be re-screened at a later date, and may be enrolled if all eligibility criteria are met at that time
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