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The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily clinical practice
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passeo-18 Lux DCB | Device | The endovascular procedure is conducted as per the local standard practice and device instruction for use |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (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 (TLR) | 6 months | |
| Freedom from clinically-driven target vessel revascularization (TVR) | 6 and 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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The BIOLUX P-III SPAIN registry will include subjects from an all-comers patient population with all subjects requiring revascularization of long femoropopliteal artery lesions with the Passeo-18 Lux DCB
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Angel de Gregorio | Hospital Clínico and University of Zaragoza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Mataró | Barcelona | Spain | ||||
| Hospital San Cecilio |
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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 |
defined as 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 months |
| Freedom from MAE | Composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven TLR | 12 months |
| Change in mean Ankle Brachial Index (ABI) | Thigh or toe brachial index (TBI) may be used / performed if ABI is inadequate | 6 and 12 months |
| Improvement in Rutherford classification compared to the pre-procedure Rutherford classification | 6 and 12 months |
| Amputation-free survival (AFS) including major, minor and overall AFS | 6 and 12 months |
| Pain score compared to the pre-procedure score | 6 and 12 months |
| Walking Impairment Questionnaire compared to the pre-procedure score | 6 and 12 months |
| Device success | Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB. | Immediately upon 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 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 |
| Granada |
| Spain |
| Hospital Regional Universitario de Málaga | Málaga | Spain |
| Hospital Virgen de la Macarena | Seville | Spain |
| Hospital Clínico Lozano Blesa Zaragoza | Zaragoza | Spain |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |