Evaluating the Oscar Catheter for Treating Peripheral Arterial Disease

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

This study is testing a new catheter to see if it can safely help people with blocked arteries in their legs feel better after treatment.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biotronik AG (Industry-sponsored)
• Locations: 16 sites (Graz and 15 other locations)
• Trial ID: NCT06758921 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with significant arterial stenosis and specific Rutherford classifications.

Not a fit: Patients with less than 70% stenosis or those with certain anatomical restrictions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with Peripheral Arterial Disease by confirming the effectiveness of a new catheter technology.

How similar studies have performed: Previous studies have shown promising results with similar catheter technologies, indicating potential for success in this approach.

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).

Where this trial is running

Graz and 15 other locations

• LKH Univ. -Klinikum Graz, Ambulanz für Angiologie — Graz, Austria (Recruiting)
• Onze Lieve Vrouwziekenhuis — Aalst, Belgium (Not_yet_recruiting)
• AZ Saint Blasius — Dendermonde, Belgium (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)
• Hopital Saint Joseph — Paris, France (Not_yet_recruiting)
• Karolinen-Hospital Arnsberg — Arnsberg, Germany (Not_yet_recruiting)
• Sankt Gertrauden-Krankenhaus — Berlin, Germany (Not_yet_recruiting)
• Universitätsklinikum Tübingen — Tübingen, Germany (Not_yet_recruiting)
• Semmelweis University — Budapest, Hungary (Not_yet_recruiting)
• Policlinico Abano Terme — Abano Terme, Italy (Not_yet_recruiting)
• Azienda Usl Toscana sud est — Arezzo, Italy (Not_yet_recruiting)
• ospedaliero-universitaria Senese — Siena, Italy (Not_yet_recruiting)
• Hospital Universitario de Guadalajara — Guadalajara, Spain (Not_yet_recruiting)
• Ospedale Regionale civico EOC di Lugano — Lugano, Switzerland (Not_yet_recruiting)

Study contacts

• Principal investigator: Koen Deloose — AZ Saint Blasius
• Study coordinator: Helene Kuissu, PharmD

Conditions Peripheral Arterial Disease