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
Study Type
OBSERVATIONAL
Enrollment
106
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)
Ziekenhuis Oost Limburg Genk
Genk, Belgium
University Hospital Gent (UZ Gent)
Ghent, Belgium
Algemeen Ziekenhuis Groeninge Kortrijk
Kortrijk, Belgium
Algemeen Ziekenhuis Delta Roeselare
Roeselare, Belgium
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)
Time frame: 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.)
Time frame: 12 months
Freedom from clinically-driven target lesion revascularization (cd-TLR)
Time frame: 6 and 24 months
Freedom from clinically-driven target vessel revascularization (TVR)
Time frame: 6, 12 and 24 months
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
Time frame: 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)
Time frame: 12 and 24 months
Change in mean Ankle Brachial Index (ABI)
compared to the pre-procedure
Time frame: 6, 12 and 24 months
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AZ Portaels
Vilvoorde, Belgium
Centre Hospitaliers Luxembourg
Luxembourg, Luxembourg
OLVG
Amsterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Maxima Medisch Centrum Veldhoven
Veldhoven, Netherlands
Improvement in Rutherford classification
compared to the pre-procedure Rutherford classification
Time frame: 6, 12 and 24 months
Amputation-free survival (AFS)
including major, minor and overall AFS
Time frame: 6, 12 and 24 months
Pain score
compared to the pre-procedure score.
Time frame: 6, 12 and 24 months
Walking Impairment Questionnaire
compared to the pre-procedure score.
Time frame: 6, 12 and 24 months
Device success
Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB
Time frame: 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
Time frame: 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
Time frame: immediately upon discharge