Observational study to confirm the safety and clinical performance of the Oscar multifunctional peripheral catheter for the dilation of lesions in the femoral, popliteal, and infrapopliteal arteries

Summary description of the study

The main objective of the BIO-OSCAR First study is to confirm the safety and effectiveness of the Oscar multifunctional catheter for the dilation of narrowed arteries located in the leg. During the intervention, the Oscar Multifunctional Catheter device will be used. The patient will be treated with this and other devices according to the instructions for use, the physician's expertise, and the hospital's standards of care. Oscar is an approved and commercially available device. The following data will be collected until the patient's discharge: • The medical history and physical examination before the intervention • ABI and Rutherford measurements before the procedure, • Information related to the procedure, including angiographic images and related data • Resources used during the procedure, • Complications that may occur during the procedure until discharge.

(BASEC)

Intervention under investigation

Endovascular treatment is a minimally invasive procedure that can help open blocked arteries and allow blood to flow better. During the procedure, the study physician inserts a long, thin, flexible tube called a catheter through a small puncture in an artery in the groin. The catheter is guided through the arteries to the blocked area. Once positioned, a special balloon attached to the catheter is inflated and deflated multiple times. The balloon pushes the plaque in the artery against the walls of the artery itself, widening the vessel. If necessary, the study physician will place a tiny metal mesh tube called a stent in the area of the artery just treated with the balloon to keep it open. The stent remains permanently in the artery. Additional treatments may be performed based on the physician's expertise.

(BASEC)

Disease under investigation

Peripheral artery disease, commonly known as peripheral vascular disease. Arteries are the blood vessels that carry oxygen-rich blood and nutrients from the heart to all areas of the body. Arteries are normally smooth and open inside, but with age, they can become blocked. A sticky substance called plaque can build up in the walls of the arteries. As plaque accumulates, the arteries narrow and harden through a process called atherosclerosis, which means hardening of the arteries. When this hardening occurs, blood flow is reduced, and the arms and legs may not receive the necessary oxygen. Doctors refer to this condition as peripheral artery disease.

(BASEC)

Sponsor

BIOTRONIK AG Ackerstrasse 6, 8180 Bülach, Switzerland

(BASEC)

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee Ticino

(BASEC)

Date of authorisation

28.07.2025

(BASEC)

Results of the trial