The trial will recruit 75 patients at a minimum of four sites in France and Germany, which will help in IDE submission to the FDA
CVT developed DCB which will be used by Cardiovascular Systems for the trial. (Credit: DarkoStojanovic from Pixabay)
Cardiovascular Systems (CSI) announced that patient recruitment has started in first in-human trial of the peripheral everolimus drug-coated balloon (DCB) developed by Chansu Vascular Technologies (CVT).
DCBs provide percutaneous interventional treatment option for femoro-popliteal lesions in patients with peripheral artery disease.
The active drug in CVT’s, Everolimus, serves as a cytostatic agent to decrease tissue hyperplasia and associated restenosis. It is said to have shown safety and efficacy in coronary drug-eluting stent applications.
Using peripheral DCB, the first patient in the trial with a 7.5 cm lesion in his superficial femoral artery (SFA) was treated by Dr. Benjamin Honton principal investigator at the Clinique Pasteur, Toulouse, France.
Honton said: “We are honoured to enroll the first patient in the CVT-SFA trial.
“We believe this promising new generation of everolimus DCBs could improve patient outcomes for those suffering from peripheral artery disease.”
The trial will recruit 75 patients at a minimum of four different sites in France and Germany. It is expected to help in the submission of Investigational Device Exemption (IDE) to the FDA and to support a pivotal clinical study in the US.
Cardiovascular Systems chief medical officer Jeffery Chambers said: “Following the announcement of the first in-human experience with CVT’s coronary everolimus DCB in November 2021, we are thrilled to announce the first in-human experience with the peripheral everolimus DCB.
“We believe these products could become important new therapies in the treatment of peripheral and coronary artery disease.”
CVT will receive milestone-based financing from CSI to develop coronary and peripheral DCBs, under an agreement with CSI.
Under an option agreement, CSI is eligible to gain exclusive rights and obligations to acquire CVT, upon completion of major technical and clinical milestones in the development programme.
In February, CSI collaborated with Innova Vascular for the development of a full line of novel thrombectomy devices.