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

Biotronik AG16 sites in 8 countries200 target enrollmentDecember 19, 2024

ConditionsPeripheral Arterial Disease Peripheral Arterial Disease(PAD)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Biotronik AG
Enrollment: 200
Locations: 16
Primary Endpoint: Oscar Procedural success rate
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 19, 2024

End Date

January 20, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Biotronik AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Oscar Procedural success rate

Time Frame: Index procedure

combination of Oscar technical success and absence of serious procedural complications

Secondary Outcomes

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)
Rate of Oscar PTA balloon related flow-limiting dissections(Index procedure)
Rate of peri-operative death (all-cause of death until discharge)(discharge (30 days))
Rate of unplanned major amputation(discharge (30 days))
Oscar crossing success(Index procedure)
Post-Oscar residual stenosis(Index procedure)
Final treatment residual stenosis (%) on the completion angiogram(Index procedure)