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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Peripheral Arterial Disease(PAD)
• Intervention / Treatment: Device: Oscar Peripheral Multifunctional Catheter

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).

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Helene Kuissu, PharmD; Phone Number: +41 44 864 54 80; Email: helene.kuissu@biotronik.com

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • LKH Univ. -Klinikum Graz, Ambulanz für Angiologie
    • Principal Investigator: Marianne Brodmann, Prof. Dr. med
• Belgium
  • Aalst, Belgium, 9300
    • Not yet recruiting
    • Onze Lieve Vrouwziekenhuis
    • Principal Investigator: Lieven Maene, MD
  • Dendermonde, Belgium, 9200
    • Recruiting
    • AZ Saint Blasius
    • Principal Investigator: Koen Deloose, MD
  • Genk, Belgium, 3600
    • Not yet recruiting
    • ZOL Ziekenhuis Oost Limburg
    • Principal Investigator: Wouter Lansink, MD
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • University Hospital Ghent
    • Principal Investigator: Bernard Peeters, MD
  • Kortrijk, Belgium, 8500
    • Not yet recruiting
    • Vzw Az Groeninge
    • Principal Investigator: Philippe Lerut, MD
• France
  • Paris, France, 75674
    • Not yet recruiting
    • Hopital Saint Joseph
    • Principal Investigator: Yann Goueffic, Prof. MD
• Germany
  • Arnsberg, Germany, 59759
    • Not yet recruiting
    • Karolinen-Hospital Arnsberg
    • Principal Investigator: Michael Lichtenberg, Dr. Med
  • Berlin, Germany, 10713
    • Not yet recruiting
    • Sankt Gertrauden-Krankenhaus
    • Principal Investigator: Ralf Langhoff, Dr. Med
  • Tübingen, Germany, 72076
    • Not yet recruiting
    • Universitatsklinikum Tubingen
    • Principal Investigator: Jörg Schmehl, Dr. Med
• Hungary
  • Budapest, Hungary, 1085
    • Not yet recruiting
    • Semmelweis University
    • Principal Investigator: Balazs Nemes, MD
• Italy
  • Abano Terme, Italy, 35031
    • Not yet recruiting
    • Policlinico Abano Terme
    • Principal Investigator: Marco Manzi, MD
  • Arezzo, Italy, 52100
    • Not yet recruiting
    • Azienda Usl Toscana sud est
    • Principal Investigator: Francesco Liistro, MD
  • Siena, Italy, 53100
    • Not yet recruiting
    • ospedaliero-universitaria Senese
    • Principal Investigator: Gianmarco de Donato, Prof. MD
• Spain
  • Guadalajara, Spain, 19002
    • Not yet recruiting
    • Hospital Universitario de Guadalajara
    • Principal Investigator: Mercedes Guerra, MD
• Switzerland
  • Lugano, Switzerland, 6962
    • Not yet recruiting
    • Ospedale Regionale civico EOC di Lugano
    • Principal Investigator: Maria Antonella Ruffino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oscar Procedural success rate	combination of Oscar technical success and absence of serious procedural complications	Index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of (Serious) Adverse Device Effects (S)ADE	(Serious) Adverse Device Effects	discharge (30 days)
Rate of distal embolization	Distal embolization	Index procedure
Rate of target vessel rupture	Target vessel rupture	Index procedure
Rate of target vessel perforation	Target vessel perforation	Index procedure
Rate of target vessel acute occlusion	Target vessel acute occlusion	Index procedure
Rate of Oscar PTA balloon related flow-limiting dissections	flow-limiting dissections defined as NHLBI grade ≥D	Index procedure
Rate of peri-operative death (all-cause of death until discharge)	peri-operative death defined as all-cause of death until discharge	discharge (30 days)
Rate of unplanned major amputation	unplanned major amputation	discharge (30 days)
Oscar crossing success	angiographic confirmation of successful placement of a guidewire into the distal true lumen with Oscar support catheter used together with the dilator and/ or Oscar PTA balloon, and without any additional crossing/re-entry device.	Index procedure
Post-Oscar residual stenosis	Post-Oscar residual stenosis (%)	Index procedure
Final treatment residual stenosis (%) on the completion angiogram	Final residual stenosis (%) on the completion angiogram	Index procedure

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: Koen Deloose, AZ Saint Blasius

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): January 20, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: C2401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No