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

March 13, 2024 updated by: Washington University School of Medicine

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

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

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Withdrawn
        • University of Alabama - Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • Withdrawn
        • UCLA
      • Orange, California, United States, 92868
        • Recruiting
        • St. Joseph's Vascular Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mahmood Razavi, MD
        • Sub-Investigator:
          • Kurt Openshaw, MD
        • Sub-Investigator:
          • Stacey Tien, PA-C
        • Sub-Investigator:
          • Tiffany Wu, MD
        • Principal Investigator:
          • Bhavraj Khalsa, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF
        • Contact:
        • Principal Investigator:
          • Kanti Kolli, MD
        • Sub-Investigator:
          • Vishal Kumar, MD
        • Sub-Investigator:
          • Evan Lehrman, MD
        • Sub-Investigator:
          • Andrew Leavitt, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital
        • Principal Investigator:
          • Cassius Iyad Ochoa Chaar, MD
        • Sub-Investigator:
          • Alfred Lee, MD
        • Sub-Investigator:
          • Henry Hsia, MD
        • Sub-Investigator:
          • Naiem Nassiri, MD
        • Sub-Investigator:
          • Robert Attaran, MD
        • Contact:
        • Contact:
    • Delaware
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Leung, MD
        • Sub-Investigator:
          • Michael Lankiewicz, MD
        • Sub-Investigator:
          • Assaf Graif, MD
        • Sub-Investigator:
          • Christopher Grilli, MD
        • Sub-Investigator:
          • Demetrios Agriantonis, MD
        • Sub-Investigator:
          • George Kimbiris, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Withdrawn
        • Piedmont Heart Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • Osmanuddin Ahmed, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jonathan Lorenz, MD
        • Sub-Investigator:
          • Jeffrey Leef, MD
        • Sub-Investigator:
          • Thuong Van Ha, MD
        • Sub-Investigator:
          • Rakesh Navuluri, MD
        • Sub-Investigator:
          • Kenneth Cohen, MD
      • Chicago, Illinois, United States, 60612
        • Completed
        • Rush Medical Center
      • Evanston, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Kush Desai, MD
        • Sub-Investigator:
          • Mark Eskandari, MD
        • Sub-Investigator:
          • Karlyn Martin, MD
        • Sub-Investigator:
          • Ramona Gupta, MD
        • Sub-Investigator:
          • Lindsey Kalhagen, MMS, PA-C
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Northshore University Health System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alfonso Tafur, MD
        • Sub-Investigator:
          • Benjamin Lind, MD
      • LaGrange, Illinois, United States, 60439
        • Withdrawn
        • AMITA Health Adventist
      • Springfield, Illinois, United States, 62769
        • Withdrawn
        • Prairie Education and Research Cooperative
      • Winfield, Illinois, United States, 60190
        • Withdrawn
        • Central DuPage
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Sabah Butty, MD
        • Sub-Investigator:
          • Thomas Casciana, MD
        • Sub-Investigator:
          • Rakesh Mehta, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Completed
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Completed
        • University of Maryland
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Newton Neidert, MD
        • Sub-Investigator:
          • Damon Houghton, MD
        • Sub-Investigator:
          • Haraldur Bjarnason, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ajinkya Desai, MD
        • Sub-Investigator:
          • Laura Vick, MD
        • Sub-Investigator:
          • Rahat Noor, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suresh Vedantham, MD
        • Sub-Investigator:
          • Naganathan Mani, MD
        • Sub-Investigator:
          • Pavan Kavali, MD
        • Sub-Investigator:
          • Nassir Rostambeigi, MD
        • Sub-Investigator:
          • Alexander Ushinsky, MD
        • Sub-Investigator:
          • Elaine Majerus, MD
        • Sub-Investigator:
          • Morey Blinder, MD
        • Sub-Investigator:
          • Amy Zhou, MD
        • Sub-Investigator:
          • Kristen Sanfilippo, MD
        • Sub-Investigator:
          • Paula Vaughn, MD
        • Sub-Investigator:
          • Daniel Harwood, MD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Keith Oereira, MD
        • Sub-Investigator:
          • Saideep Bose, MD
        • Principal Investigator:
          • Jake Button, MD
        • Sub-Investigator:
          • Jerome Kao, MD
        • Sub-Investigator:
          • Ali Malik, MD
        • Sub-Investigator:
          • Mudresh Mehta, MD
        • Sub-Investigator:
          • Alejandro Mendez-Castillo, MD
        • Sub-Investigator:
          • David Owens, MD
        • Sub-Investigator:
          • Xavier Packianathan, MD
        • Sub-Investigator:
          • Nabeel Rajeh, MD
        • Sub-Investigator:
          • Radu Serban, MD
        • Sub-Investigator:
          • Afsheen Sherwani, MD
        • Sub-Investigator:
          • Elise Sullivan, MD
        • Sub-Investigator:
          • Kirubahara Vaheesan, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Completed
        • St. Elizabeth's Hospital
    • New York
      • New York, New York, United States, 10003
        • Active, not recruiting
        • New York University Medical Center
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian-Weill Cornell Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ronald Winokur, MD
        • Sub-Investigator:
          • Maria DeSancho, MD
        • Sub-Investigator:
          • Soo Rhee, MD
        • Sub-Investigator:
          • Christopher Harnain, MD
        • Sub-Investigator:
          • Hana Lim, MD
        • Sub-Investigator:
          • Kimberly Scherer, MD
        • Sub-Investigator:
          • Akhilesh Sista, MD
      • Plattsburgh, New York, United States, 12901
        • Recruiting
        • University of Vermont Health Network - CVPH
        • Contact:
        • Principal Investigator:
          • Steven Deso, MD
        • Sub-Investigator:
          • Julio Lemos, MD
      • Staten Island, New York, United States, 10305
        • Completed
        • Staten Island Hospital
      • Stony Brook, New York, United States, 11794
        • Completed
        • Stony Brook Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Completed
        • University Hospitals Cleveland Medical Center
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • Jobst Vascular Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Fish, MD
        • Sub-Investigator:
          • Zakaria Assi, MD
        • Sub-Investigator:
          • Drew Oostra, MD
        • Sub-Investigator:
          • Jihad Abbas, MD
        • Sub-Investigator:
          • Babatunde Oriowo, MD
        • Sub-Investigator:
          • Andrew Seiwert, MD
        • Sub-Investigator:
          • Gregory Kasper, MD
        • Sub-Investigator:
          • Sophia Afridi, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73014
        • Completed
        • University of Oklahoma
    • Oregon
      • Portland, Oregon, United States, 97239
        • Completed
        • Oregon Health & Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Taki Galamis, MD
        • Sub-Investigator:
          • Luis Eraso, MD
        • Principal Investigator:
          • Robert Ford, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Withdrawn
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Completed
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15213
        • Completed
        • University of Pittsburg
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Withdrawn
        • Rhode Island Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Completed
        • University of Texas Health Science Center at Houston
    • Utah
      • Provo, Utah, United States, 84604
        • Withdrawn
        • Intermountain Healthcare
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Withdrawn
        • Inova Alexandria Hospital
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Sub-Investigator:
          • Daniel Sheeran, MD
        • Sub-Investigator:
          • Luke Wilkins, MD
        • Sub-Investigator:
          • James Stone, MD
        • Principal Investigator:
          • Adiyta Sharma, MD
        • Contact:
        • Contact:
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Health System
        • Contact:
        • Principal Investigator:
          • Ezana Azene, MD
        • Sub-Investigator:
          • Todd Kowalski, MD
        • Sub-Investigator:
          • Clark Davis, MD
        • Sub-Investigator:
          • Jonanthan Zlabek, MD
        • Sub-Investigator:
          • Kurt Ziegelbein, MD
        • Sub-Investigator:
          • Irina Shaknovich, MD
        • Sub-Investigator:
          • Patrick Self, MD
        • Contact:
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Hohenwalter, MD.
        • Sub-Investigator:
          • James Gosset, MD
        • Sub-Investigator:
          • Kellie Brown, MD
        • Sub-Investigator:
          • Michael Malinowski, MD
        • Sub-Investigator:
          • Matthew Scheidt, MD
        • Sub-Investigator:
          • Brandon Key, MD
        • Sub-Investigator:
          • Parag Patel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Subjects must meet BOTH of these Criteria

  1. Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > or = 3 months duration in a leg with history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator.

  2. Ipsilateral iliac vein obstruction documented within 12 months prior to screening by either:

    1. Occlusion or >50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or
    2. 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: Subjects meeting any of these criteria will be excluded.

  1. 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
  3. Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
  4. Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein
  5. Absence of PTS of at least moderate severity
  6. Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented)
  7. Presence of open venous ulcer > 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg
  8. Inability to tolerate endovascular procedure due to acute illness, or general health
  9. Severe allergy to iodinated contrast refractory to steroid premedication
  10. Known allergy to stent or catheter components
  11. Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.05, or platelet count < 75,000/ml
  12. Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min)
  13. Disseminated intravascular coagulation or other major bleeding diathesis
  14. Pregnancy (positive pregnancy test)
  15. Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
  16. Inability to provide informed consent or to comply with study assessments

Note - patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endovascular Therapy - Intervention

All subjects (EVT and No-EVT Arms) will receive optimal PTS care. At each Clinical Center, this will be supervised by a physician experienced in managing PTS.

Subjects randomized to EVT will receive the following:

  1. imaging-guided iliac vein stent placement, and
  2. endovenous ablation of refluxing saphenous vein(s), if the patient has truncal reflux and is still symptomatic.
  3. optimal PTS therapy: medical and compression, lifestyle interventions and venous ulcer care
Device: Stents

US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram 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 dilated to at least 14 mm, unless compelling patient factors dictates dilatation to a smaller diameter.

Balloon angioplasty of inflow veins.

After successful iliac vein recanalization, patients who continue to be symptomatic beyond 2 weeks follow-up and who have valvular reflux in GSV, accessory GSV, anterolateral thigh circumflex, and/or SSV should be offered endovenous ablation.

Any FDA-approved method may be used including radiofrequency or laser ablation, sclerotherapy or pharmacomechanical ablation.
No Intervention: Non-Endovascular Therapy - Control
All subjects will receive optimal PTS care as noted above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTS Severity
Time Frame: over 6 months follow-up
250 patients with moderate to severe post thrombotic syndrome (PTS) and iliac vein obstruction will receive optimal PTS therapy. 50% of those patients will also receive endovenous therapy; modified antithrombotic therapy, including anti-platelet agent, iliac vein stenting, and endovenous ablation of refluxing saphenous veins if indicated. At 6 months post-randomization, venous clinical severity scores (VCSS) will be obtained and PTS severity will be evaluated.
over 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Massachusetts General Hospital
Ontario Clinical Oncology Group (OCOG)
St. Luke's Hospital, Kansas City, Missouri

Investigators

  • Principal Investigator: Suresh Vedantham, M.D., Clinical Coordinating Center at Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

April 27, 2026

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201707130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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