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

NCT03250247 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-01-28

No results posted yet for this study

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

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

Interventions

DEVICE

Stents

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.

Sponsors & Collaborators

  • Ontario Clinical Oncology Group (OCOG)

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Saint Luke's Mid America Heart Institute

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Suresh Vedantham, M.D. · Clinical Coordinating Center at Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2025-11-11
Completion
2026-04-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03250247 on ClinicalTrials.gov