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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03250247
Other study ID # 201707130
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2, 2018
Est. completion date April 27, 2026

Study information

Verified date March 2024
Source Washington University School of Medicine
Contact Mary Clare Derfler, RN MSN
Phone 314-973-0739
Email Derflerm@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Description:

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. 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.


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Study Design


Intervention

Device:
Stents
US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram 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 dilated to at least 14 mm, unless compelling patient factors dictates dilatation to a smaller diameter. Balloon angioplasty of inflow veins. After successful iliac vein recanalization, patients who continue to be symptomatic beyond 2 weeks follow-up and who have valvular reflux in GSV, accessory GSV, anterolateral thigh circumflex, and/or SSV should be offered endovenous ablation. Any FDA-approved method may be used including radiofrequency or laser ablation, sclerotherapy or pharmacomechanical ablation.

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Sponsors (4)

Lead Sponsor Collaborator
Washington University School of Medicine Massachusetts General Hospital, Ontario Clinical Oncology Group (OCOG), St. Luke's Hospital, Kansas City, Missouri

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PTS Severity 250 patients with moderate to severe post thrombotic syndrome (PTS) and iliac vein obstruction will receive optimal PTS therapy. 50% of those patients will also receive endovenous therapy; modified antithrombotic therapy, including anti-platelet agent, iliac vein stenting, and endovenous ablation of refluxing saphenous veins if indicated. At 6 months post-randomization, venous clinical severity scores (VCSS) will be obtained and PTS severity will be evaluated. over 6 months follow-up
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