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
Study Type
OBSERVATIONAL
Enrollment
44
The endovascular procedure is conducted as per the local standard practice and device instruction for use
Hospital Mataró
Barcelona, Spain
Hospital San Cecilio
Granada, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Virgen de la Macarena
Seville, Spain
Hospital Clínico Lozano Blesa Zaragoza
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)
Time frame: 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.)
Time frame: 12 months
Freedom from clinically-driven target lesion revascularization (TLR)
Time frame: 6 months
Freedom from clinically-driven target vessel revascularization (TVR)
Time frame: 6 and 12 months
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.
Time frame: 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
Time frame: 12 months
Change in mean Ankle Brachial Index (ABI)
Thigh or toe brachial index (TBI) may be used / performed if ABI is inadequate
Time frame: 6 and 12 months
Improvement in Rutherford classification compared to the pre-procedure Rutherford classification
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Zaragoza, Spain
Time frame: 6 and 12 months
Amputation-free survival (AFS) including major, minor and overall AFS
Time frame: 6 and 12 months
Pain score compared to the pre-procedure score
Time frame: 6 and 12 months
Walking Impairment Questionnaire compared to the pre-procedure score
Time frame: 6 and 12 months
Device success
Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB.
Time frame: 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.
Time frame: 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
Time frame: Immediately upon discharge