Clinical trial 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)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Peripheral Arterial Disease(PAD)
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2025-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 200 patients will be enrolled, with approximately 100 subjects in ATK group, and 100 subjects in BTK group.

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.

Detailed 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).

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).

Primary outcomes:
measure: Oscar Procedural success rate
timeFrame: Index procedure
Secondary outcomes:
measure: Rate of (Serious) Adverse Device Effects (S)ADE
timeFrame: discharge (30 days)
measure: Rate of distal embolization
timeFrame: Index procedure
measure: Rate of target vessel rupture
timeFrame: Index procedure
measure: Rate of target vessel perforation
timeFrame: Index procedure
measure: Rate of target vessel acute occlusion
timeFrame: Index procedure
measure: Rate of Oscar PTA balloon related flow-limiting dissections
timeFrame: Index procedure
measure: Rate of peri-operative death (all-cause of death until discharge)
timeFrame: discharge (30 days)
measure: Rate of unplanned major amputation
timeFrame: discharge (30 days)
measure: Oscar crossing success
timeFrame: Index procedure
measure: Post-Oscar residual stenosis
timeFrame: Index procedure
measure: Final treatment residual stenosis (%) on the completion angiogram
timeFrame: Index procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Univ. -Klinikum Graz, Ambulanz für Angiologie
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis
city: Dendermonde
country: Belgium
facility: AZ Saint Blasius
city: Genk
country: Belgium
facility: ZOL Ziekenhuis Oost Limburg
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Kortrijk
country: Belgium
facility: vzw AZ Groeninge
city: Paris
country: France
facility: Hopital Saint Joseph
city: Arnsberg
country: Germany
facility: Karolinen-Hospital Arnsberg
city: Berlin
country: Germany
facility: Sankt Gertrauden-Krankenhaus
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Budapest
country: Hungary
facility: Semmelweis University
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
city: Arezzo
country: Italy
facility: Azienda Usl Toscana sud est
city: Siena
country: Italy
facility: ospedaliero-universitaria Senese
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Lugano
country: Switzerland
facility: Ospedale Regionale civico EOC di Lugano
Study officials:
affiliation: AZ Saint Blasius
name: Koen Deloose
role: PRINCIPAL_INVESTIGATOR
References: