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)

Recruiting

• Conditions: Peripheral Arterial Disease; Peripheral Arterial Disease(PAD)

• Registration Number: NCT06758921
• Lead Sponsor: Biotronik AG

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).

Study Timeline

• Study First Submitted: 2024-10-31
• Status Verified: 2024-12
• Study Start: 2024-12-19
• Study First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-12-20
• Study Completion: 2026-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oscar Procedural success rate	Index procedure	combination of Oscar technical success and absence of serious procedural complications

Secondary Outcome Measures

Name	Time	Method
Rate of (Serious) Adverse Device Effects (S)ADE	discharge (30 days)	(Serious) Adverse Device Effects
Rate of distal embolization	Index procedure	Distal embolization
Rate of target vessel rupture	Index procedure	Target vessel rupture
Rate of target vessel perforation	Index procedure	Target vessel perforation
Rate of target vessel acute occlusion	Index procedure	Target vessel acute occlusion
Rate of Oscar PTA balloon related flow-limiting dissections	Index procedure	flow-limiting dissections defined as NHLBI grade ≥D
Rate of peri-operative death (all-cause of death until discharge)	discharge (30 days)	peri-operative death defined as all-cause of death until discharge
Rate of unplanned major amputation	discharge (30 days)	unplanned major amputation
Oscar crossing success	Index procedure	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.
Post-Oscar residual stenosis	Index procedure	Post-Oscar residual stenosis (%)
Final treatment residual stenosis (%) on the completion angiogram	Index procedure	Final residual stenosis (%) on the completion angiogram

Trial Locations

Locations (16)

LKH Univ. -Klinikum Graz, Ambulanz für Angiologie; 🇦🇹 Graz, Austria

Onze Lieve Vrouwziekenhuis; 🇧🇪 Aalst, Belgium

AZ Saint Blasius; 🇧🇪 Dendermonde, Belgium

ZOL Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium

vzw AZ Groeninge; 🇧🇪 Kortrijk, Belgium

Hopital Saint Joseph; 🇫🇷 Paris, France

Karolinen-Hospital Arnsberg; 🇩🇪 Arnsberg, Germany

Sankt Gertrauden-Krankenhaus; 🇩🇪 Berlin, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Semmelweis University; 🇭🇺 Budapest, Hungary

Policlinico Abano Terme; 🇮🇹 Abano Terme, Italy

Azienda Usl Toscana sud est; 🇮🇹 Arezzo, Italy

ospedaliero-universitaria Senese; 🇮🇹 Siena, Italy

Hospital Universitario de Guadalajara; 🇪🇸 Guadalajara, Spain

Ospedale Regionale civico EOC di Lugano; 🇨🇭 Lugano, Switzerland