Pathway Medical Technologies announced enrolment of the first patient in its Jetstream G3 calcium study, a prospective, single-arm, multicentre registry to evaluate the treatment effects of the Jetstream G3 system in patients with moderate to severely calcified peripheral artery disease.
The Jetstream G3 Calcium study will be conducted at six medical centres across the United States and will initially enrol up to 50 patients. The first patient was enrolled by Malcolm Foster at East Tennessee Heart Consultants and Baptist Hospital West in Knoxville, Tennessee, USA.
“Peripheral artery disease affects more than 12 million people in the US alone,” said William A Gray, principal investigator, director of Endovascular Services, Center for Interventional Vascular Therapy at New York-Presbyterian Hospital. “The current standard of care often involves the use of multiple devices to treat different disease morphologies and extensive recovery times for patients, especially for those with difficult-to-treat blockages. With the Jetstream G3 Calcium study, we hope to demonstrate the efficiency and long-term effectiveness of this single technology capable of treating a broad spectrum of vascular disease patients, including those with moderate to severe calcium build up.”
The Jetstream G3 is a minimally invasive catheter-based system that removes atherosclerotic disease and thrombus in the peripheral vasculature. It actively and simultaneously aspirates excised debris, reducing procedure time and cost. The system is FDA cleared for atherectomy use in the peripheral vasculature and for breaking apart and removing thrombus in peripheral arteries.
The study will evaluate the ability of the Jetstream G3 to effectively remove calcium build up and achieve luminal gain in patients with symptomatic peripheral vascular disease who are undergoing percutaneous intervention. Assessment and quantification of luminal gain and calcium removal in peripheral artery disease interventions pre- and post-treatment will be determined using intravascular ultrasound (IVUS). In addition, the study also will evaluate the use of the device as an adjunctive therapy and monitor residual diameter stenosis, preservation of runoff and the incidence of major adverse events up to 30 days.
Enrolment in the Jetstream G3 Calcium study is open to any patients eligible for treatment with the Jetstream G3 system who meet the inclusion criteria. Additional information about eligibility requirements and exclusions can be found at: http://clinicaltrials.gov/ct2/show/NCT01273623