Health Trials

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)

ConditionsPeripheral Arterial DiseasePeripheral Arterial Disease(PAD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiotronik AG

About this trial

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.

Eligibility criteria

Qualifiers

Subject ≥18 years old

Subject has provided written informed consent

Subject has Rutherford classification 2 to 6

Reference vessel diameter ≥2 and ≤7 mm

Disqualifiers

Subject has a single target lesion that involves both ATK and BTK segments.

Subject not suitable for receiving endovascular procedures of lower limb arteries.

Prior planned major amputation in the target limb (i.e., above the ankle).

Subject with previous bypass surgery of target vessel.

Trial design

Treatments tested in this trial

  • Oscar Peripheral Multifunctional Catheter

Treatment groups

No treatment groups listed

Sponsors and collaborators

Biotronik AG

Lead sponsor

Source ClinicalTrials.gov