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

Not Applicable

Recruiting

• Conditions: Deep Vein Thrombosis; Venous Leg Ulcer; Post Thrombotic Syndrome; Venous Stasis; Venous Insufficiency; Venous Reflux
• Interventions: Device: Stents

• Registration Number: NCT03250247
• Lead Sponsor: Washington University School of Medicine

Brief 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).

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 Timeline

• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Study Start: 2018-07-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-01-30
• Study Completion: 2026-04-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovascular Therapy - Intervention	Stents	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

Primary Outcome Measures

Name	Time	Method
PTS Severity	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.

Trial Locations

Locations (43)

University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

UCLA; 🇺🇸 Los Angeles, California, United States

St. Joseph's Vascular Institute; 🇺🇸 Orange, California, United States

UCSF; 🇺🇸 San Francisco, California, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Christiana Care Hospital; 🇺🇸 Newark, Delaware, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Rush Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

NorthShore University Health System; 🇺🇸 Evanston, Illinois, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States

AMITA Health Adventist; 🇺🇸 LaGrange, Illinois, United States

Prairie Education and Research Cooperative; 🇺🇸 Springfield, Illinois, United States

Central DuPage; 🇺🇸 Winfield, Illinois, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

St. Louis University Hospital; 🇺🇸 Saint Louis, Missouri, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

St. Elizabeth's Hospital; 🇺🇸 Lincoln, Nebraska, United States

New York University Medical Center; 🇺🇸 New York, New York, United States

New York Presbyterian-Weill Cornell Medicine; 🇺🇸 New York, New York, United States

University of Vermont Health Network - CVPH; 🇺🇸 Plattsburgh, New York, United States

Staten Island Hospital; 🇺🇸 Staten Island, New York, United States

Stony Brook Hospital; 🇺🇸 Stony Brook, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Jobst Vascular Institute; 🇺🇸 Toledo, Ohio, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

Oregon Health & Sciences University; 🇺🇸 Portland, Oregon, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburg; 🇺🇸 Pittsburgh, Pennsylvania, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Intermountain Healthcare; 🇺🇸 Provo, Utah, United States

Inova Alexandria Hospital; 🇺🇸 Alexandria, Virginia, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Gundersen Health System; 🇺🇸 La Crosse, Wisconsin, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States