BTK Cohort Results Presented From QT Vascular's Chocolate Registry

August 31, 2015—QT Vascular Ltd. announced that the final results of the below-the-knee (BTK) cohort of patients in the Chocolate Balloon Angioplasty Registry (BAR) were presented by Principal Investigator Jihad Mustapha, MD, at the 5th annual Amputation Prevention Symposium, which was held August 12–15 in Chicago, Illinois.

In the Chocolate BAR study, BTK patients treated with the Chocolate percutaneous transluminal angioplasty (PTA) balloon catheter compared favorably against historical outcomes of conventional balloon angioplasty reported in the literature, with a lower rate of bail-out stent placement (4.9% vs 9.9%), as well lower 30-day and 6-month rates of target lesion revascularization (2.2% vs 8.1%; 9% vs 16%), major amputation (1.3% vs 4.4–6.6%; 3.2%–11.8%), and overall mortality (0.9% vs 1.7–3.3%; 2.9% vs 7.7%), respectively. QT Vascular noted that a randomized controlled study would further define the potential treatment benefit of the Chocolate PTA for BTK lesions.

Dr. Mustapha commented in the company’s press release, “A significant part of my practice is treating patients with BTK disease. These patients have more progressed disease and are often at risk for higher complication rate including amputation and even death. The results from Chocolate BAR are very positive. Drug-coated balloons have not yet shown to be effective for interventions below the knee. With Chocolate PTA, even without a drug, we now have the tool to improve outcomes in this very sick group of patients.” Dr. Mustapha is with Metro Health Hospital in Wyoming, Michigan.

QT Vascular stated that the Chocolate BAR is an observational registry collecting data on real-world use with the Chocolate PTA to assess its effectiveness in achieving optimal PTA procedural outcomes, and its potential longer-term clinical benefits. A total of 226 BTK patients were enrolled and agreed to undergo 3 months of follow-up. A cohort of 123 patients was scheduled for 6 months follow-up. In addition, 264 above-the-knee patients were enrolled for a total of 490 patients treated at 33 centers in the United States. The final results for the above-the-knee patient cohort will be presented later in 2015.

The Chocolate PTA balloon catheter, has received European CE Mark approval and US Food and Drug Administration clearance. QT Vascular is based in Singapore with a United States subsidiary, TriReme Medical LLC, which is based in Pleasanton, California.