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)

Biotronik

Status: Enrolling

Conditions: Peripheral Arterial Disease(PAD); Peripheral Arterial Disease

Treatments: Device: Oscar Peripheral Multifunctional Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT06758921

C2401

Details and patient eligibility

About

The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.

Full description

This is a prospective, multicenter, all-comers observational study. Primary endpoint was procedural success (defined as a combination of successful primary target lesion crossing, residual stenosis of ≤30% following vessel preparation and before definite treatment) and absence of procedural complications (defined as target vessel perforation or rupture, acute occlusion, and distal embolization).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).