Deep Vein ThrombosisC-TRACTNCT03250247
Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
A study testing Stents in people with Deep Vein Thrombosis and Venous Stasis, run by Washington University School of Medicine at 29 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency
- What is being tested?
- Stents
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 29 sitesUnited States
- Study dates
- 2 Jul 2018to 27 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Subjects must meet BOTH of these Criteria
- 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.
- Ipsilateral iliac vein obstruction documented within 12 months prior to consent by either:
- Occlusion or >50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or
- 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.
- Age less than 18 years
- Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned
- Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
- Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein
- Absence of PTS of at least moderate severity
- 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)
- 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
- Inability to tolerate endovascular procedure due to acute illness, or general health
- Severe allergy to iodinated contrast refractory to steroid premedication
- Known allergy to stent or catheter components
- Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.0, or platelet count < 75,000/ml
- Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min)
- Disseminated intravascular coagulation or other major bleeding diathesis
- Pregnancy (positive pregnancy test)
- Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
University of Maryland
Baltimore, Maryland, 21201
University of North Carolina
Chapel Hill, North Carolina, 27517
University of Virginia
Charlottesville, Virginia, 22908
Rush Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
NorthShore University Health System
Evanston, Illinois, 60201
Northwestern University
Evanston, Illinois, 60208
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Gundersen Health System
La Crosse, Wisconsin, 54601
St. Elizabeth's Hospital
Lincoln, Nebraska, 68510
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Yale New Haven Hospital
New Haven, Connecticut, 06510
New York University Medical Center
New York, New York, 10003
Christiana Care Hospital
Newark, Delaware, 19718
New York Presbyterian-Weill Cornell Medicine
NewYork, New York, 10065
University of Oklahoma
Oklahoma City, Oklahoma, 73014
St. Joseph's Vascular Institute
Orange, California, 92868
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburg
Pittsburgh, Pennsylvania, 15213
University of Vermont Health Network - CVPH
Plattsburgh, New York, 12901
Oregon Health & Sciences University
Portland, Oregon, 97239
UCSF
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
Staten Island Hospital
Staten Island, New York, 10305
Jobst Vascular Institute
Toledo, Ohio, 43606
About this study
Official title: 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).
Read the detailed description
The rationale for performing the C-TRACT Trial is based upon:
- 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);
- the inability of existing therapies to prevent or alleviate most cases of DIO-PTS;
- the role of iliac vein obstruction and saphenous reflux in causing the severe manifestations of DIO-PTS;
- 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;
- the risks, costs, and uncertainties of this novel but invasive strategy;
- the lack of consensus on whether EVT should be used for DIO-PTS;
- 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
- Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency, Venous Leg Ulcer, Venous Reflux, Post Thrombotic Syndrome
- Being tested
- Stents
- Keywords
- deep vein thrombosis, superficial venous reflux, blood clot, post thrombotic syndrome, iliac vein obstruction
- Medical subject headings
- Venous Thrombosis, Varicose Ulcer, Venous Insufficiency, Postthrombotic Syndrome, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentsDevice
US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram and intravascular ultrasound 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 should be dilated to at least 14 mm, unless compelling patient factors dictate dilatation to a smaller diameter.
Balloon angioplasty of inflow veins if needed to optimize inflow, per standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Therapy | Experimental | Subjects randomized to EVT will receive the following:
1. imaging-guided iliac vein stent placement;
2. anticoagulant therapy for at least 6 months;
3. oral aspirin 81 mg for at least 6 months; and
4. optimal PTS therapy: medical, compression, lifestyle measures, and venous ulcer care Receives: Device: Stents |
| No-Endovascular Therapy - Control | No intervention | Optimal PTS therapy: medical, compression, lifestyle measures, and venous ulcer care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTS Severity
"Venous Clinical Severity Scale (VCSS) score, adjusted for baseline"
Measured: over 6 months follow-up
Secondary outcomes (22)
Venous quality of life
VEINES-QOL questionnaire
Measured: 6 months
Gereric quality of life
Short-Form-36 survey, physical component score
Measured: 6 months
Estimated calf volume
Measure calf length/diameter, formula for truncated cone
Measured: 6 months
Presence of open ulcer
Blinded clinic assessment
Measured: 6 months
PTS severity (secondary)
Villalta PTS Scale score
Measured: 6 months
Major bleeding
Overt, requiring > 2 units pRBC or critical location
Measured: 6 months
Recurrent venous thrombeombolism
Objectively confirmed proximal DVT or PE
Measured: 6 months
Death
All-cause mortality
Measured: 6 months
Valvular reflux
Venous Segmental Disease Scale, reflux score
Measured: 6 months
Venous obstruction
Venous Segmental Disease Scale, obstruction score
Measured: 6 months
Venous quality of life
VEINES-QOL questionnaire
Measured: 12 months
Gereric quality of life
Short-Form-36 survey, physical component score
Measured: 12 months
PTS severity (remote)
Patient-Reported Villalta
Measured: 12 months
Venous quality of life
VEINES-QOL questionnaire
Measured: 18 months
Gereric quality of life
Short-Form-36 survey, physical component score
Measured: 18 months
PTS severity (remote)
Patient-Reported Villalta
Measured: 18 months
Venous quality of life
VEINES-QOL questionnaire
Measured: 24 months
Gereric quality of life
Short-Form-36 survey, physical component score
Measured: 24 months
PTS severity (remote)
Patient-Reported Villalta
Measured: 24 months
Major bleeding
Overt, requiring > 2 units pRBC or critical location
Measured: 24 months
Recurrent venous thrombeombolism
Objectively confirmed proximal DVT or PE
Measured: 24 months
Death Death
All-cause mortality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start2 Jul 2018
- Primary completion11 Nov 2025
- Study completion27 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an NIH-funded, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Clinical Oncology Group (OCOG), Massachusetts General Hospital, Saint Luke's Mid America Heart Institute
- Responsible party
- Sponsor
- Investigators
- Suresh Vedantham, M.D., Principal investigator, Clinical Coordinating Center at Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250247
- Sponsor's protocol ID
- 201707130
- Acronym
- C-TRACT
- Status last verified
- Jan 2026
- First submitted
- 5 Jul 2017
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Vedantham S, Kahn SR, Marston WA, Weinberg I, Sista AK, Magnuson EA, Cohen DJ, Wasan SM, Razavi MK, Goldhaber SZ, Sanfilippo KM, Comerota AJ, Azene EM, Chaar CIO, Leung DA, Kolli KP, Kalva SP, Rostambeigi N, Desai A, Desai KR, Tafur AJ, Khalsa B, Majerus E, Wang B, Wang Y, Nieters P, Derfler MC, Oliver A, Hardy C, Bashir R, Winokur R, Weger N, Khaja MS, Sharma A, Mani N, Kavali P, Thukral S, Lake LL, Mikkelsen K, Parpia S; C-TRACT Trial Investigators. Endovascular Therapy for Post-Thrombotic Syndrome - A Randomized Trial. N Engl J Med. 2026 Jun 18;394(23):2293-2304. doi: 10.1056/NEJMoa2519001. Epub 2026 Apr 13.
PubMed 41972998Flumignan 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.
PubMed 39968829
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial
- ClinicalTrials.gov ID
- NCT03250247
- Acronym / sponsor ID
- C-TRACT / 201707130
- Conditions
- Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency, Venous Leg Ulcer, Venous Reflux, Post Thrombotic Syndrome
- Keywords
- deep vein thrombosis, superficial venous reflux, blood clot, post thrombotic syndrome, iliac vein obstruction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Ontario Clinical Oncology Group (OCOG), Massachusetts General Hospital, Saint Luke's Mid America Heart Institute
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 27 Apr 2026 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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);
- the inability of existing therapies to prevent or alleviate most cases of DIO-PTS;
- the role of iliac vein obstruction and saphenous reflux in causing the severe manifestations of DIO-PTS;
- 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;
- the risks, costs, and uncertainties of this novel but invasive strategy;
- the lack of consensus on whether EVT should be used for DIO-PTS;
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is an NIH-funded, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Endovascular Therapy | Experimental | Device: StentsSubjects randomized to EVT will receive the following: 1. imaging-guided iliac vein stent placement; 2. anticoagulant therapy for at least 6 months; 3. oral aspirin 81 mg for at least 6 months; and 4. optimal PTS therapy: medical, compression, lifestyle measures, and venous ulcer care |
| No-Endovascular Therapy - Control | No intervention | –Optimal PTS therapy: medical, compression, lifestyle measures, and venous ulcer care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StentsUS-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram and intravascular ultrasound 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 should be dilated to at least 14 mm, unless compelling patient factors dictate dilatation to a smaller diameter. Balloon angioplasty of inflow veins if needed to optimize inflow, per standard practice. | Device | Endovascular Therapy |
Primary outcome
PTS Severity
Time frame: over 6 months follow-up
"Venous Clinical Severity Scale (VCSS) score, adjusted for baseline"
22 secondary outcomes
Venous quality of life
Time frame: 6 months
Gereric quality of life
Time frame: 6 months
Estimated calf volume
Time frame: 6 months
Presence of open ulcer
Time frame: 6 months
PTS severity (secondary)
Time frame: 6 months
Major bleeding
Time frame: 6 months
Recurrent venous thrombeombolism
Time frame: 6 months
Death
Time frame: 6 months
Valvular reflux
Time frame: 6 months
Venous obstruction
Time frame: 6 months
Venous quality of life
Time frame: 12 months
Gereric quality of life
Time frame: 12 months
PTS severity (remote)
Time frame: 12 months
Venous quality of life
Time frame: 18 months
Gereric quality of life
Time frame: 18 months
PTS severity (remote)
Time frame: 18 months
Venous quality of life
Time frame: 24 months
Gereric quality of life
Time frame: 24 months
PTS severity (remote)
Time frame: 24 months
Major bleeding
Time frame: 24 months
Recurrent venous thrombeombolism
Time frame: 24 months
Death Death
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 41972998Vedantham S, Kahn SR, Marston WA, Weinberg I, Sista AK, Magnuson EA, Cohen DJ, Wasan SM, Razavi MK, Goldhaber SZ, Sanfilippo KM, Comerota AJ, Azene EM, Chaar CIO, Leung DA, Kolli KP, Kalva SP, Rostambeigi N, Desai A, Desai KR, Tafur AJ, Khalsa B, Majerus E, Wang B, Wang Y, Nieters P, Derfler MC, Oliver A, Hardy C, Bashir R, Winokur R, Weger N, Khaja MS, Sharma A, Mani N, Kavali P, Thukral S, Lake LL, Mikkelsen K, Parpia S; C-TRACT Trial Investigators. Endovascular Therapy for Post-Thrombotic Syndrome - A Randomized Trial. N Engl J Med. 2026 Jun 18;394(23):2293-2304. doi: 10.1056/NEJMoa2519001. Epub 2026 Apr 13.
- Derived from this study: PubMed 39968829Flumignan 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suresh Vedantham, M.D. principal investigator
Clinical Coordinating Center at Washington University School of Medicine
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stents in people with Deep Vein Thrombosis and Venous Stasis, run by Washington University School of Medicine at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTS Severity (time frame: over 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03250247, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.