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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Oscar Procedural success rate | combination of Oscar technical success and absence of serious procedural complications | Index procedure |
| 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 |
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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.
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
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.
Subject lacking capacity to provide informed consent.
Subject under judicial protection, tutorship, or curatorship (for France only).
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A total of 200 patients will be enrolled, with approximately 100 subjects in ATK group, and 100 subjects in BTK group.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helene Kuissu, PharmD | Contact | +41 44 864 54 80 | helene.kuissu@biotronik.com |
| Name | Affiliation | Role |
|---|---|---|
| Koen Deloose | AZ Saint Blasius | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Univ. -Klinikum Graz, Ambulanz für Angiologie | Recruiting | Graz | 8036 | Austria |
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| 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 |
| Onze Lieve Vrouwziekenhuis | Not yet recruiting | Aalst | 9300 | Belgium |
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| AZ Saint Blasius | Recruiting | Dendermonde | 9200 | Belgium |
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| ZOL Ziekenhuis Oost Limburg | Not yet recruiting | Genk | 3600 | Belgium |
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| University Hospital Ghent | Not yet recruiting | Ghent | 9000 | Belgium |
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| vzw AZ Groeninge | Not yet recruiting | Kortrijk | 8500 | Belgium |
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| Hopital Saint Joseph | Not yet recruiting | Paris | 75674 | France |
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| Karolinen-Hospital Arnsberg | Not yet recruiting | Arnsberg | 59759 | Germany |
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| Sankt Gertrauden-Krankenhaus | Not yet recruiting | Berlin | 10713 | Germany |
|
| Universitätsklinikum Tübingen | Not yet recruiting | Tübingen | 72076 | Germany |
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| Semmelweis University | Not yet recruiting | Budapest | 1085 | Hungary |
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| Policlinico Abano Terme | Not yet recruiting | Abano Terme | 35031 | Italy |
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| Azienda Usl Toscana sud est | Not yet recruiting | Arezzo | 52100 | Italy |
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| ospedaliero-universitaria Senese | Not yet recruiting | Siena | 53100 | Italy |
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| Hospital Universitario de Guadalajara | Not yet recruiting | Guadalajara | 19002 | Spain |
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| Ospedale Regionale civico EOC di Lugano | Not yet recruiting | Lugano | 6962 | Switzerland |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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