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



Status:Recruiting
Conditions:Other Indications, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:May 7, 2018
End Date:July 1, 2023
Contact:Angela Oliver, RN, BSN, MS
Email:olivera@wustl.edu
Phone:314-747-8951

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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).

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.

374 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. Clinical Centers, and followed for 24
months. The study will take approximately 6 years to complete.

Inclusion Criteria:

1. Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease >
3 months duration in a leg with history of DVT; and b) either a Venous Clinical
Severity Score (VCSS) > 8 or a Villalta PTS Scale score > 10 or an open venous ulcer);
and

2. Ipsilateral iliac vein obstruction documented within 3 months prior to screening by
either:

1. Occlusion 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:

1. Age less than 18 years

2. 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. Documented obstruction (occlusion or > 50% diameter stenosis) of an IVC filter

5. Chronic arterial limb ischemia (ankle-brachial index < 0.5)

6. Presence of open venous ulcer > 50 cm2 area, or suspicion for active ulcer infection
in the ipsilateral leg

7. Inability to tolerate endovascular procedure due to acute illness, or general health

8. Severe allergy to iodinated contrast refractory to steroid premedication

9. Known allergy to stent or catheter components

10. Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.5, or platelet count < 50,000/ml

11. Severe renal impairment (estimated GFR < 30 ml/min)

12. Disseminated intravascular coagulation or other major bleeding diathesis

13. Pregnancy (positive pregnancy test)

14. Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS

15. Inability to provide informed consent or to comply with study assessments Note -
patients who initially meet an exclusion criterion can be re-screened at a later date,
and may be enrolled if all eligibility criteria are met at that time.
We found this trial at
27
sites
425 East 61st Street
New York, New York 10065
Principal Investigator: Ronald Winokur, MD
Phone: 212-746-9748
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Marc Passman, M.D.
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Mel Sharafuddin, MD
Phone: 319-353-8736
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Timothy Murphy, M.D.
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Alexandria, Virginia 22304
Principal Investigator: Keith Sterling, MD
Phone: 703-504-7760
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: William Marston, MD
Phone: 919-843-1268
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Evanston, Illinois 60208
Principal Investigator: Kush Desai, MD
Phone: 312-695-4023
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1900 South Avenue
La Crosse, Wisconsin 54601
Principal Investigator: Ezana Azene, MD
Phone: 608-775-0238
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LaGrange, Illinois 60439
Principal Investigator: Michael Sichlau, MD
Phone: 847-640-5605
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555 South 70th Street
Lincoln, Nebraska 68510
Phone: 402-219-7936
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Stephen Kee, M.D.
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Eric Hohenwalter, MD.
Phone: 414-805-2077
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Cassius Iyad Ochoa Chaar, MD
Phone: 203-785-7153
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New York, New York 10021
Principal Investigator: Akhilesh Sista, MD
Phone: 212-263-0414
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Newark, Delaware 19718
Principal Investigator: Daniel Leung, MD
Phone: 302-733-4112
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Suman Rathbun, MD
Phone: 405-271-8001
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Orange, California 92868
Principal Investigator: Mahmood Razavi, MD
Phone: 714-744-8795
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Deepak Sudheendra, MD
Phone: 215-662-6983
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Riyaz Bashir, MD
Phone: 215-707-5340
Temple University Temple University is many things to many people. A place to pursue life's...
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Pittsburgh, Pennsylvania 15524
Principal Investigator: Eric Hager, MD
Phone: 412-623-8486
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Portland, Oregon 97227
Principal Investigator: John Kaufman, MD
Phone: 503-494-7226
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920 North 500 West
Provo, Utah 84604
Principal Investigator: Carl Black, M.D.
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Suresh Vedantham, MD
Phone: 314-747-8951
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Staten Island, New York 10305
Principal Investigator: Jonathan Schor, MD
Phone: 718-226-6129
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Stony Brook, New York 11794
Principal Investigator: Antonios Gasparis, MD
Phone: 631-974-3174
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Toledo, Ohio 43606
Principal Investigator: John Fish, MD
Phone: 419-291-7182
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25 Winfield Road
Winfield, Illinois 60190
Principal Investigator: Joseph Schneider, MD
Phone: 630-399-7581
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