Enroll Patients in C-TRACT and Support a Culture of Research

Dear AVLS Members,

We are writing to ask for your help in developing the evidence that supports your ability to provide valuable therapies to patients in the future.

Today, we are struggling to enroll patients in C-TRACT — a study designed to assess interventional therapies for chronic venous disease in patients with moderate to severe post-thrombotic syndrome (PTS). FDA-approved stents are available for the treatment of venous disease, but there is limited payment and coverage for venous stenting, with MEDCAC determining in 2016 that there has been no randomized clinical trial looking at this disease to help them determine that there should be payment and coverage for venous stenting.

The AVLS has been the leading body that advocates for payment and coverage policy for therapies you provide to patients. In the now distant past, payment and coverage was typically provided if we told carriers what we did for patients was good. Over time, carriers have required more robust data to support payment and coverage, as we have all moved toward embracing evidence-based medicine for our patients.

We do not have good data proving that stenting is better than not stenting these patients. Expanded payment and coverage rests on development of data through clinical trials. Suresh Vedantham, MD, FSIR, has developed the C-TRACT trial through the NHLBI, and taxpayers are paying $12 million to help us find the answer to this question. Many patients are being treated by IR for PTS, some of whom would qualify to be enrolled in this trial, but trial enrollment has been very slow. We need to complete this trial to determine how best to treat patients with venous disease, to be able to advocate for payment and coverage, and to gain the ability to fund other critical IR trials.

Here is how you can help:

• Register as a study site to enroll patients
• Refer potential candidates to sites that can enroll the patient
•     Rather than thinking that you have lost a patient or lost a procedure, consider this as an investment for future referrals and future payment for procedures. Other specialties have learned the value of referring patients for clinical trials, and IRs should consider adopting this mindset as an investment in the future.
•     Contact Dr. Vedantham to find the best referral site for your patient. Email [email protected]; text or call (314) 283-8846.
•     Download the Referral Tool (app) to your device (type “C-TRACT” in Apple/Google app stores)
• Educate patients and families on the benefits of participation

We often think we “know” something is effective because we see patients benefit—but this local knowledge must be converted into published data in order to become real to the rest of the world, and to allow you to provide the service to future patients. Help us make this data a reality by getting involved in C-TRACT today.

Sincerely,

Mark H. Meissner, MD, FAVLS

President, American Vein & Lymphatic Society