Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)

Launched by BIOTRONIK AG · Dec 28, 2024

Keywords

ClinConnect Summary

The BIO-OSCAR First trial is a study designed to evaluate the safety and effectiveness of a special catheter called the Oscar Peripheral Multifunctional Catheter. This catheter is used to treat blockages in the arteries of the legs, specifically in areas known as the femoral, popliteal, and infrapopliteal arteries. The study aims to gather information about how well standard medical procedures work, any complications that may occur during the procedure, and how patients recover after treatment.

To participate in this trial, you need to be at least 18 years old and have specific types of arterial blockages, which are assessed by a doctor. Eligible participants will have blockages that are at least 70% narrowed, and there must be healthy artery sections near the blockage. The study is open to both men and women, and it is currently recruiting participants. If you join the study, you can expect to receive standard care procedures while also contributing to important research that could help improve treatments for others with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject ≥18 years old
• • 2. Subject has provided written informed consent
• • 3. Subject has Rutherford classification 2 to 6
• • 4. Reference vessel diameter ≥2 and ≤7 mm
• • 5. Target lesion(s) has stenosis \>70% by visual assessment
• • 6. Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between will be considered one lesion.
• Above the knee (ATK) group:
• • 7. Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
• • 8. At least one below-knee artery patent to the ankle
• • 9. Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion stenosis can be treated during the same procedure as per local standard of care. The inflow lesion(s) must be treated first, prior to consideration of treatment of the target lesion. Subject can be enrolled if the inflow lesion(s) are treated and result in ≤30% residual stenosis and no evidence of embolization or significant complications.
• Below the knee (BTK) group:
• • 10. Target lesions involve arteries below the tibial plateau
• • 11. Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications
• Exclusion Criteria:
• • 1. Subject has a single target lesion that involves both ATK and BTK segments.
• • 2. Subject not suitable for receiving endovascular procedures of lower limb arteries.
• • 3. Prior planned major amputation in the target limb (i.e., above the ankle).
• • 4. Subject with previous bypass surgery of target vessel.
• • 5. History of any open surgical procedure within the past 30 days.
• • 6. Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb.
• • Note: The inflow vessels can be treated on the day of the procedure.
• • 7. Subject has Oscar IFU listed contraindication (such as uncorrected bleeding disorders, sepsis).
• • 8. Subject under dialysis.
• • 9. Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached.
• • 10. Subject lacking capacity to provide informed consent.
• • 11. Subject under judicial protection, tutorship, or curatorship (for France only).