QT Vascular, together with its subsidiaries, has enrolled the first 11 patients in its First-In-Human (FIH) study of its novel Chocolate Touch PTCA (Coronary Drug Coated Chocolate) in the Dominican Republic.
This study initiation represents achievement of key milestone ahead of time. Working closely with local and US physicians, QT Vascular has embarked on a potentially revolutionary study to evaluate the clinical utility of the Chocolate Touch PTCA for the treatment of de novo coronary lesions.
If successful, this study would provide initial evidence of a new and unique device that could be able to treat the most common coronary disease in a way that minimizes the placement of stents in at least some lesion subsets.
Stenting is currently the most commonly used treatment in coronary interventions, but it is a permanent implant that requires expensive long-term dual anti-platelet therapy and is associated with small but significant risks of fracture (1) and late-thrombosis.
The initial procedural outcomes with Chocolate Touch PTCA were successful in all 11 patients and importantly, no stent placement was required. There were also no cases with abrupt closure and no significant dissections were observed.
"I am pleased with the initial acute angiographic results of the Chocolate Touch PTCA; they look closer to a stent than a balloon. I have not observed any sub-acute occlusion in these patients which is one of the major risks with conventional balloons," stated Dr. Jihad Mustapha of Metro Health Hospital, Wyoming, Michigan who performed some of the first cases.
Chocolate Touch PTCA is based on the unique Chocolate balloon platform. By reducing acute trauma, Chocolate was able to reduce severe dissections and thus reduce the need for unplanned stenting in the peripheral arteries when compared to conventional balloons.
With the addition of the proven anti-proliferative drug, paclitaxel, Chocolate Touch PTCA offers the potential to achieve improved acute outcomes that will hold up over time due to paclitaxel’s ability to reduce the body’s response that may lead to the need for repeat interventions.
"I am pleased to offer to my patient this drug-coated balloon therapy that does not require a stent," stated Dr. Carlos Garcia Lithgow of CECANOT Hospital in Santo Domingo, Dominican Republic. "In my country, the post-stent drug regimen is very expensive and many patients do not comply due to the high cost."