Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial) (C-TRACT)
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|ClinicalTrials.gov Identifier: NCT03250247|
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : October 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis Venous Stasis Venous Insufficiency Venous Leg Ulcer Venous Reflux Post Thrombotic Syndrome||Device: Stents||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||374 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
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:
|Official Title:||Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial|
|Actual Study Start Date :||July 2, 2018|
|Estimated Primary Completion Date :||February 29, 2024|
|Estimated Study Completion Date :||August 31, 2024|
Experimental: Endovascular Therapy - Intervention
All subjects (EVT and No-EVT Arms) will receive optimal PTS care. At each Clinical Center, this will be supervised by a physician experienced in managing PTS.
Subjects randomized to EVT will receive the following:
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.
No Intervention: Non-Endovascular Therapy - Control
All subjects will receive optimal PTS care as noted above.
- PTS Severity [ Time Frame: over 6 months follow-up ]374 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250247
|Contact: David Winkfield, BSfirstname.lastname@example.org|
|Contact: Patty Nieters, RN, BSNemail@example.com|
|Principal Investigator:||Suresh Vedantham, M.D.||Clinical Coordinating Center at Washington University School of Medicine|