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The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passeo-18 Lux DCB | Device | The decision to treat the patient with Passeo-18 DCB is at the investigator discretion. The endovascular procedure is performed as per standard of care and device Instructions For Use (IFU) |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Major Adverse Events (MAE) | Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) | 6 months |
| Freedom from clinically driven target lesion revascularization (cd-TLR) | Any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from clinically-driven target lesion revascularization (cd-TLR) | 6 and 24 months | |
| Freedom from clinically-driven target vessel revascularization (TVR) | 6, 12 and 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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The BIOLUX P-III BENELUX registry will include subjects from an all-comers patient population with all subjects requiring popliteal artery revascularization with the Passeo-18 Lux DCB
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| Name | Affiliation | Role |
|---|---|---|
| Franck Vermassen | UZ Gent | Principal Investigator |
| JGAM Blomjous | OLVG Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost Limburg Genk | Genk | Belgium | ||||
| University Hospital Gent (UZ Gent) |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Primary patency |
freedom from >50% restenosis in the target lesion as indicated by a duplex ultrasound peak systolic velocity ratio (PSVR) >2.5 or by visual assessment of an angiogram with no clinically driven re-intervention |
| 12 and 24 months |
| Freedom from Major Adverse Events (MAE) | Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR) | 12 and 24 months |
| Change in mean Ankle Brachial Index (ABI) | compared to the pre-procedure | 6, 12 and 24 months |
| Improvement in Rutherford classification | compared to the pre-procedure Rutherford classification | 6, 12 and 24 months |
| Amputation-free survival (AFS) | including major, minor and overall AFS | 6, 12 and 24 months |
| Pain score | compared to the pre-procedure score. | 6, 12 and 24 months |
| Walking Impairment Questionnaire | compared to the pre-procedure score. | 6, 12 and 24 months |
| Device success | Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB | immediately upon index procedure |
| Technical success | Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation | immediately upon index procedure |
| Procedural success | Procedural success is technical and device success without the occurrence of any MAE (as defined in the protocol) during the hospital stay | immediately upon discharge |
| Ghent |
| Belgium |
| Algemeen Ziekenhuis Groeninge Kortrijk | Kortrijk | Belgium |
| Algemeen Ziekenhuis Delta Roeselare | Roeselare | Belgium |
| AZ Portaels | Vilvoorde | Belgium |
| Centre Hospitaliers Luxembourg | Luxembourg | Luxembourg |
| OLVG | Amsterdam | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | Netherlands |
| Maxima Medisch Centrum Veldhoven | Veldhoven | Netherlands |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |