Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Kanti Kolli, MD

Description

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).

Official Title

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

Details

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.

Keywords

Deep Vein Thrombosis Venous Stasis Venous Insufficiency Venous Leg Ulcer Venous Reflux Post Thrombotic Syndrome superficial venous reflux blood clot iliac vein obstruction Thrombosis Venous Thrombosis Varicose Ulcer Postthrombotic Syndrome Postphlebitic Syndrome Leg Ulcer Stents

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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
  2. Ipsilateral iliac vein obstruction documented within 3 months prior to screening by either:
  3. Occlusion or >50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or
  4. 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.

You CAN'T join if...

  1. Age less than 18 years
    1. Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned
  2. Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
  3. Documented obstruction (occlusion or > 50% diameter stenosis) of an IVC filter
  4. Chronic arterial limb ischemia (ankle-brachial index < 0.5)
  5. Presence of open venous ulcer > 50 cm2 area, or suspicion for active ulcer infection in the ipsilateral leg
  6. Inability to tolerate endovascular procedure due to acute illness, or general health
  7. Severe allergy to iodinated contrast refractory to steroid premedication
  8. Known allergy to stent or catheter components
  9. . Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.5, or platelet count < 50,000/ml
  10. . Severe renal impairment (estimated GFR < 30 ml/min)
  11. . Disseminated intravascular coagulation or other major bleeding diathesis
  12. . Pregnancy (positive pregnancy test)
  13. . Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
  14. . 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.

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • UCLA withdrawn
    Los Angeles California 90095 United States

Lead Scientist

  • Kanti Kolli, MD
    K. Pallav Kolli, MD, is an Associate Professor of Clinical Radiology in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Washington University School of Medicine
ID
NCT03250247
Study Type
Interventional
Last Updated