Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Deep Vein Thrombosis
- Post Thrombotic Syndrome
- Venous Insufficiency
- Venous Leg Ulcer
- Venous Reflux
- Venous Stasis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is an NIH-funded, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial.Masking: Single (Outcomes Assessor)Masking Description: Clinical assessments for PTS will be obtained at baseline (pre-randomization) and at the 6, 12, 18 and 24-month follow-up visits. Examining clinicians will complete PTS training to ensure accuracy across all Clinical Centers. The examiners for PTS must be blinded to the subjects' treatment allocation. Subjects will be reminded not reveal to clinic staff which therapy they received (EVT or No-EVT). Subjects should be examined in the afternoon (the later the better) to allow the symptoms and signs of PTS to manifest. The assessment is performed as follows: 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. 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. Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 obstr...
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. 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.
Tracking Information
- NCT #
- NCT03250247
- Collaborators
- Ontario Clinical Oncology Group (OCOG) - McMaster University
- VasCore - Massachusetts General Hospital
- Mid America Heart Institute - St. Luke's Hospital
- Investigators
- Principal Investigator: Suresh Vedantham, M.D. Clinical Coordinating Center at Washington University School of Medicine
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