SIR Today 2021| March 25, 2021
The Chronic Venous Thrombosis: Relief with Adjunctive Catheter-delivered Therapy (C-TRACT) Trial, a randomized, multicenter trial sponsored by the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH), is still enrolling patients. C-TRACT, which launched in 2018, is led by Suresh Vedantham, MD, FSIR, of the Mallinckrodt Institute of Radiology, Washington University in St. Louis.
The trial aims to bring together 20–40 clinical centers to enroll 374 subjects to determine whether the use of endovascular therapy reduces the clinical severity of moderate-to-severe post-thrombotic syndrome (PTS) and improves quality of life, compared with traditional treatment. According to Dr. Vedantham, although IRs have long delivered endovascular therapy to PTS patients, there is a need for high-quality studies and further investigation of long-term efficacy.
The C-TRACT Trial is furthering the findings of the 2017 ATTRACT trial, which found that clot-busting treatments helped improve recovery from deep vein thrombosis (DVT) and reduced the severity of PTS.
“The ATTRACT Trial showed that preventing PTS is not straightforward and that mechanisms beyond ‘open veins’ must be involved,” said Dr. Vedantham. “ATTRACT essentially found that it’s the people with iliofemoral DVT who are the ones most likely to benefit and that, in fact, quality of life was improved in the iliofemoral patients. And so that certainly suggests that we’re barking up the right tree with the C-TRACT Trial.”
However, C-TRACT Trial investigators have struggled to enroll the needed number of sites and participants, despite the community’s desire for evidence-based research and the support of a $12 million investment by the NIH for an IR-led study. Currently, there are 94 randomized patients, 31 active clinical centers and 8 new sites in start-up—which is promising, but still almost 300 subjects short of the goal.
“The study will only succeed if practicing IRs take a ‘study before stent’ approach and routinely refer their patients to study sites,” says Dr. Vedantham. “Physicians and insurers know that endovascular treatment is unproven and expensive, so if IRs want to preserve access to the best PTS care for their patients, the time to act is now, before new coverage decisions introduce additional barriers."
Dr. Vedantham encourages IRs to consider the myriad benefits of enrolling:
- Offering patients access to a structure program of quality PTS care and monitoring
- The ability to further physician reputations as highly credible, evidence-driven and balanced, as evidenced by their participation in an NIH-sponsored randomize trial
- Supporting IR involvement and education in NIH-sponsored, FDA-monitored clinical trials
- For applicable patients, stenting in a closely monitored study environment with independent safety oversight
- For patients not randomized to endovascular therapy, excellent medical, compressive and ulcer care with the opportunity to be stented later should the evidence recommend it
SIR leadership stresses the importance of referring patients to the study—it’s easy to enroll, and member participation in C-TRACT is one of the most demonstrable ways to help build a culture of research within the society and the foundation.
The C-TRACT Trial is seeking teams that deliver high-quality, multidisciplinary venous care and that specifically possess a strong ability to re-open occluded iliac veins; ability to deliver anticoagulation, compression and professional venous ulcer care; institutional ability to function in a rigorous trial with NIH and FDA oversight; and a willingness to be highly proactive in putting in place mechanisms to identify and enroll PTS patients.
Interested members can download the C-TRACT referral app by typing “C-TRACT” into their phone’s Apple or Google-play App Store. Members can also obtain more information at bloodclotstudy.wustl.edu/c-tract or by contacting Dr. Vedantham (email@example.com).
Hear more about the C-TRACT Trial from Dr. Vedantham in episode 5 of The Kinked Wire podcast.