Last updated on June 2020

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

Brief description of study

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).

Detailed Study 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.

Clinical Study Identifier: NCT03250247

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Stony Brook Hospital

Stony Brook, NY United States
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Gundersen Health System

La Crosse, WI United States
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University of Pennsylvania

Philadelphia, PA United States
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Yale New Haven Hospital

New Haven, CT United States
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Staten Island Hospital

Staten Island, NY United States
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Temple University

Philadelphia, PA United States
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Central DuPage

Winfield, IL United States
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University of Iowa

Iowa City, IA United States
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University of Pittsburg

Pittsburgh, PA United States
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St. Elizabeth's Hospital

Lincoln, NE United States
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Los Angeles, CA United States
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Christiana Care Hospital

Newark, DE United States
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Northwestern University

Evanston, IL United States
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AMITA Health Adventist

LaGrange, IL United States
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University of North Carolina

Chapel Hill, NC United States
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Jobst Vascular Institute

Toledo, OH United States
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University of Oklahoma

Oklahoma City, OK United States
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Rhode Island Hospital

Providence, RI United States
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Intermountain Healthcare

Provo, UT United States
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Inova Alexandria Hospital

Alexandria, VA United States
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Medical College of Wisconsin

Milwaukee, WI United States
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San Francisco, CA United States
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University of Maryland

Baltimore, MD United States
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University of Chicago

Chicago, IL United States
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Rush Medical Center

Chicago, IL United States
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Recruitment Status: Open

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