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)

NCT06758921 | Recruiting

• 1 other identifier: C2401
• Study Type: observational
• Target: 200
• Locations: 8 countries
• Sites: 16

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.

Conditions

Peripheral Arterial Disease; Peripheral Arterial Disease(PAD)

Outcome Measures

Primary Outcomes (1)

• Oscar Procedural success rate

  combination of Oscar technical success and absence of serious procedural complications

  Index procedure

Secondary Outcomes (11)

• Rate of (Serious) Adverse Device Effects (S)ADE

  discharge (30 days)

• Rate of distal embolization

  Index procedure

• Rate of target vessel rupture

  Index procedure

• Rate of target vessel perforation

  Index procedure

• Rate of target vessel acute occlusion

  Index procedure

Interventions

Oscar Peripheral Multifunctional Catheter DEVICE

Oscar Peripheral Multifunctional Catheter encompasses three components: (i) Oscar Support Catheter with integrated Lock Grip, (ii) Oscar Dilator and (iii) Oscar PTA Balloon. Single Oscar PTA Balloon is also available separately and can only be used together with the pre-supplied Oscar Support Catheter as indicated in the compatibility chart in the Instructions for Use (IFU).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject ≥18 years old
• Subject has provided written informed consent
• Subject has Rutherford classification 2 to 6
• Reference vessel diameter ≥2 and ≤7 mm
• Target lesion(s) has stenosis \>70% by visual assessment
• Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between will be considered one lesion.
• Above the knee (ATK) group:
• Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
• At least one below-knee artery patent to the ankle
• 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:
• Target lesions involve arteries below the tibial plateau
• 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

You may not qualify if:

• 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.
• History of any open surgical procedure within the past 30 days.
• 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.
• Subject has Oscar IFU listed contraindication (such as uncorrected bleeding disorders, sepsis).
• Subject under dialysis.
• Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached.
• Subject lacking capacity to provide informed consent.
• Subject under judicial protection, tutorship, or curatorship (for France only).

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (16)

LKH Univ. -Klinikum Graz, Ambulanz für Angiologie

Graz, 8036, Austria

RECRUITING

Onze Lieve Vrouwziekenhuis

Aalst, 9300, Belgium

NOT YET RECRUITING

AZ Saint Blasius

Dendermonde, 9200, Belgium

RECRUITING

ZOL Ziekenhuis Oost Limburg

Genk, 3600, Belgium

NOT YET RECRUITING

University Hospital Ghent

Ghent, 9000, Belgium

NOT YET RECRUITING

vzw AZ Groeninge

Kortrijk, 8500, Belgium

NOT YET RECRUITING

Hopital Saint Joseph

Paris, 75674, France

NOT YET RECRUITING

Karolinen-Hospital Arnsberg

Arnsberg, 59759, Germany

NOT YET RECRUITING

Sankt Gertrauden-Krankenhaus

Berlin, 10713, Germany

NOT YET RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

NOT YET RECRUITING

Semmelweis University

Budapest, 1085, Hungary

NOT YET RECRUITING

Policlinico Abano Terme

Abano Terme, 35031, Italy

NOT YET RECRUITING

Azienda Usl Toscana sud est

Arezzo, 52100, Italy

NOT YET RECRUITING

ospedaliero-universitaria Senese

Siena, 53100, Italy

NOT YET RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

NOT YET RECRUITING

Ospedale Regionale civico EOC di Lugano

Lugano, 6962, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Koen Deloose

  AZ Saint Blasius

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene Kuissu, PharmD

CONTACT

+41 44 864 54 80; helene.kuissu@biotronik.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: January 6, 2025
• Study Start: December 19, 2024
• Primary Completion: December 20, 2025
• Study Completion: January 20, 2026
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

FR (1); IT (3); AU (1); BE (5); CH (1); ES (1); DE (3); HU (1)