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

NCT03250247 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 201707130
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 29

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PTS Severity

  "Venous Clinical Severity Scale (VCSS) score, adjusted for baseline"

  over 6 months follow-up

Secondary Outcomes (22)

• Venous quality of life

  6 months

• Gereric quality of life

  6 months

• Estimated calf volume

  6 months

• Presence of open ulcer

  6 months

• PTS severity (secondary)

  6 months

Study Arms (2)

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

Device: Stents

No-Endovascular Therapy - Control

NO INTERVENTION

Optimal PTS therapy: medical, compression, lifestyle measures, and venous ulcer care

Interventions

Stents DEVICE

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.

Endovascular Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Ontario Clinical Oncology Group (OCOG): collaborator
• Massachusetts General Hospital: collaborator
• Saint Luke's Mid America Heart Institute: collaborator

Study Sites (29)

St. Joseph's Vascular Institute

Orange, California, 92868, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Christiana Care Hospital

Newark, Delaware, 19718, United States

Location

Rush Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

St. Elizabeth's Hospital

Lincoln, Nebraska, 68510, United States

Location

New York University Medical Center

New York, New York, 10003, United States

Location

New York Presbyterian-Weill Cornell Medicine

NewYork, New York, 10065, United States

Location

University of Vermont Health Network - CVPH

Plattsburgh, New York, 12901, United States

Location

Staten Island Hospital

Staten Island, New York, 10305, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73014, United States

Location

Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburg

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 39968829 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Varicose Ulcer; Venous Insufficiency; Postthrombotic Syndrome; Thrombosis

Interventions

Stents

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Suresh Vedantham, M.D.

  Clinical Coordinating Center at Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: PTS is assessed at the 6-month follow-up visit. The examiner must be a study-designated blinded clinician (MD, RN, APRN, or PA) who has completed study-specific PTS training to standardize across sites. PTS examiners must be blinded to participant treatment arm allocation. Subjects are reminded to not reveal to clinic staff which therapy they received (EVT or No-EVT). Subjects should be examined in the afternoon to allow the symptoms and signs of PTS to manifest. 1. The subject should be asked to rate the symptoms on the Villalta PTS scale for each leg, record his/her ratings, and complete the QOL questionnaires. 2. The subject's legs should be unclothed and he/she should be seated facing the blinded clinician examiner. Without access to the subject's rating of symptoms, the examiner assesses the clinical signs required for the Villalta and VCSS measures. 3. Leg ulcers are assessed and measured by appropriately qualified personnel who are unaware of treatment arm allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an NIH-funded, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: August 15, 2017
• Study Start: July 2, 2018
• Primary Completion: November 11, 2025
• Study Completion: April 27, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (29)