Evaluating the Oscar Catheter for Treating Peripheral Arterial Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety and clinical performance of the Oscar Peripheral Multifunctional Catheter in patients with lesions in the femoral, popliteal, and infrapopliteal arteries. It will evaluate standard care practices, procedural outcomes, and in-hospital complications associated with endovascular interventions. The primary endpoint focuses on procedural success, defined by successful lesion crossing and minimal residual stenosis, alongside the absence of complications during the procedure.

Why it matters

Who can join: the full rules

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).

Where it's running

• LKH Univ. -Klinikum Graz, Ambulanz für Angiologie
  Graz, Austria Recruiting
• AZ Saint Blasius
  Dendermonde, Belgium Recruiting
• Onze Lieve Vrouwziekenhuis
  Aalst, Belgium Not yet recruiting
• ZOL Ziekenhuis Oost Limburg
  Genk, Belgium Not yet recruiting
• University Hospital Ghent
  Ghent, Belgium Not yet recruiting
• vzw AZ Groeninge
  Kortrijk, Belgium Not yet recruiting

Study contacts

• Principal investigator: Koen Deloose — AZ Saint Blasius
• Study coordinator: Helene Kuissu, PharmD
• Email: helene.kuissu@biotronik.com
• Phone: +41 44 864 54 80

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.