NCT06758921 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)
| NCT ID | NCT06758921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biotronik AG |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-12-19 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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).
Contact & Investigator
Koen Deloose
PRINCIPAL INVESTIGATOR
AZ Saint Blasius
Frequently Asked Questions
Who can join the NCT06758921 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06758921 currently recruiting?
Yes, NCT06758921 is actively recruiting participants. Contact the research team at helene.kuissu@biotronik.com for enrollment information.
Where is the NCT06758921 trial being conducted?
This trial is being conducted at Graz, Austria, Aalst, Belgium, Dendermonde, Belgium, Genk, Belgium and 11 additional locations.
Who is sponsoring the NCT06758921 clinical trial?
NCT06758921 is sponsored by Biotronik AG. The principal investigator is Koen Deloose at AZ Saint Blasius. The trial plans to enroll 200 participants.