Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
NCT ID: NCT03250247
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
250 participants
INTERVENTIONAL
2018-07-02
2026-04-27
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
1. The subject should be asked to rate the 5 symptoms on the Villalta PTS scale for each leg, record his/her ratings on the CRF.
2. The subject's legs should be unclothed and he/she should be seated facing the blinded clinician (nurse or physician).The 5 signs of PTS and VCSS measures will be recorded by the blinded clinician. Leg ulcers (if present) will be assessed and measured.
Study Groups
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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
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.
Non-Endovascular Therapy - Control
All subjects will receive optimal PTS care as noted above.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ontario Clinical Oncology Group (OCOG)
OTHER
Massachusetts General Hospital
OTHER
Saint Luke's Mid America Heart Institute
UNKNOWN
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Suresh Vedantham, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinical Coordinating Center at Washington University School of Medicine
Locations
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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
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
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland
Baltimore, Maryland, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University School of Medicine
St 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
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburg
Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at Houston
Houston, Texas, 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
Countries
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References
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Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
Other Identifiers
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201707130
Identifier Type: -
Identifier Source: org_study_id