Peripheral Arterial Disease, Peripheral Arterial Disease(PAD)
Conditions
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).
Interventions
DEVICEOscar Peripheral Multifunctional Catheter
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).
Sponsors
Biotronik AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oscar Procedural success rate | Index procedure | combination of Oscar technical success and absence of serious procedural complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (Serious) Adverse Device Effects (S)ADE | discharge (30 days) | (Serious) Adverse Device Effects |
| 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 |
| 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 |
Countries
Austria, Belgium, France, Germany, Hungary, Italy, Spain, Switzerland
Contacts
Primary ContactHelene Kuissu, PharmD
Outcome results
None listed