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Piedmont Atlanta First in Metro Atlanta to Enroll in VIVID Clinical Trial

Atlanta (April 26, 2021) – Piedmont Atlanta Hospital is now offering a treatment option to those suffering from Chronic Venous Insufficiency (CVI) as part of the VIVID Trial. The VIVID Trial, sponsored by Vesper Medical, will evaluate the safety and efficacy of the Vesper DUO Venous Stent System® in the treatment of patients with iliofemoral occlusive disease.

“We are thrilled to be among the first to study this stent and offer it to patients throughout Georgia,” said Charles B. Ross, M.D., a vascular and endovascular surgeon with Piedmont Heart Institute, who is serving as the principal investigator on the study. “Obstruction of the deep veins has been challenging to treat with the first generation of venous stents due to the varying anatomical and mechanical demands. The distinctive design of the Vesper DUO System uniquely combines the necessary venous stent properties into the single DUO HYBRID stent and, when used in conjunction with DUO EXTEND stent, gives me the ability to customize therapy for each of my patients.”

Obstruction in the deep venous system is increasingly recognized as a major cause of chronic venous disease. It is estimated that more than 30 million adults in the United States have some form of venous disease, with CVI being a common health problem occurring in up to 5% of the population.[1] A person with CVI can experience symptoms like severe swelling, pain, or even skin discoloration and ulcers. Venous obstruction can occur as a result of different causes, including thrombotic (blood clot related) and non-thrombotic lesions.

The VIVID Trial is a global study and will enroll 160 patients in up to 45 centers in the United States and Europe. Patients with both thrombotic and non-thrombotic disease will be included to evaluate the safety and efficacy of the Vesper DUO Stent System. This prospective, multi-center, single arm study’s primary safety endpoint is freedom from Major Adverse Events (MAE) at 30 days and primary efficacy endpoint is primary patency of the stented segment at 12 months. Patients enrolled in the study will be followed for three years. More information can be found on https://clinicaltrials.gov/ct2/show/NCT04580160?term=04580160&draw=2&rank=1.

 

[1] The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American VenousForum. Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, WakefieldTW, Society for Vascular Surgery., American Venous Forum. J Vasc Surg. 2011 May; 53(5 Suppl):2S-48.

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