ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2018-07-02

Study Completion:2026-04-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03250247

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Suresh Vedantham, M.D.

PRINCIPAL_INVESTIGATOR

Clinical Coordinating Center at Washington University School of Medicine

Study Locations (Sites)

St. Joseph's Vascular Institute

Orange, California, 92868

United States

UCSF

San Francisco, California, 94143

United States

Yale New Haven Hospital

New Haven, Connecticut, 06510

United States

Christiana Care Hospital

Newark, Delaware, 19718

United States

Rush Medical Center

Chicago, Illinois, 60612

United States

University of Chicago

Chicago, Illinois, 60637

United States

NorthShore University Health System

Evanston, Illinois, 60201

United States

Northwestern University

Evanston, Illinois, 60208

United States

Indiana University

Indianapolis, Indiana, 46202

United States

University of Iowa

Iowa City, Iowa, 52242

United States

University of Maryland

Baltimore, Maryland, 21201

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

St. Elizabeth's Hospital

Lincoln, Nebraska, 68510

United States

New York University Medical Center

New York, New York, 10003

United States

New York Presbyterian-Weill Cornell Medicine

New York, New York, 10065

United States

University of Vermont Health Network - CVPH

Plattsburgh, New York, 12901

United States

Staten Island Hospital

Staten Island, New York, 10305

United States

Stony Brook Hospital

Stony Brook, New York, 11794

United States

University of North Carolina

Chapel Hill, North Carolina, 27517

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Jobst Vascular Institute

Toledo, Ohio, 43606

United States

University of Oklahoma

Oklahoma City, Oklahoma, 73014

United States

Oregon Health & Sciences University

Portland, Oregon, 97239

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Temple University

Philadelphia, Pennsylvania, 19140

United States

University of Pittsburg

Pittsburgh, Pennsylvania, 15213

United States

University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

University of Virginia

Charlottesville, Virginia, 22908

United States

Gundersen Health System

La Crosse, Wisconsin, 54601

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Suresh Vedantham, M.D., PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2018-07-02

Study Completion Date2026-04-27

Study Record Updates

Study Start Date2018-07-02

Study Completion Date2026-04-27

Terms related to this study

Keywords Provided by Researchers

deep vein thrombosis
superficial venous reflux
blood clot
post thrombotic syndrome
iliac vein obstruction

Additional Relevant MeSH Terms

Deep Vein Thrombosis
Venous Stasis
Venous Insufficiency
Venous Leg Ulcer
Venous Reflux
Post Thrombotic Syndrome