DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease

Device success, defined as successful delivery, inflation, and retrieval of the assigned balloon catheter, resulting in a residual stenosis <30% without flow-limiting dissection (FLD) on final angiography.

Technical success, defined as successful use of a device or technique to re-establish vessel patency with a residual stenosis <30% by visual estimation and <50% by duplex during the index procedure.

Procedural cost, defined as the total acquisition cost (€) of all lesion preparation balloons (including adjunctive predilatation balloons, if required) and bailout stents used during the index procedure for the target lesion.

Slow-flow phenomenon, defined as an angiographic reduction in antegrade flow occurring after DCB inflation compared with the immediately preceding angiogram, in the absence of residual stenosis >30%, flow-limiting dissection, or vasospasm. The presence or absence of slow-flow phenomenon will be determined by the independent blinded angiographic review.

Procedural success, defined as technical success with absence of rupture, distal embolization, thrombosis, access complications, or major adverse cardiovascular events. These events should be listed as occurring <24 hours and <1 month of the procedure.

Freedom from device and procedure-related death through 30 days post-procedure.

Freedom from Major Adverse Events (MAE) up to 24 months post-procedure.

MAE are defined as the composite of:

• Major Adverse Cardiovascular Events (MACE), including all-cause death, myocardial infarction, stroke, or major bleeding requiring transfusion or surgical intervention.
• Major Adverse Limb Events (MALE), including above-the-ankle target limb amputation or major re-intervention involving the target lesion, defined as new bypass graft, jump/interposition graft revision, thrombectomy, thrombolysis or endovascular reintervention.

Primary patency at 6 and 24 months post-procedure, defined as absence of ≥50% restenosis (peak systolic velocity ratio<2.5) and no CD-TLR, as adjudicated by the duplex core laboratory and the Clinical Events Committee (CEC).

Freedom from CD-TLR up to 24 months post-procedure.

• CD-TLR is defined as any repeat revascularisation procedure performed to maintain or restore patency within the treated segment, including 5 mm proximal and 5 mm distal to the edges of the originally treated lesion, due to clinical deterioration.
• Clinical deterioration is defined as a ≥1-category worsening in Rutherford classification, impaired wound healing, or new or recurrent ulceration or rest pain attributable to the target lesion

Change in Rutherford classification up to 24 months post-procedure.

Change in EQ-5D questionnaire from baseline up to 24 months post-procedure

Amputation free survival up to 24 months post-procedure.

• Amputation free survival is defined as survival without above-the-ankle amputation of the target limb.

Wound healing evolution up to 24 months post-procedure, assessed according to the following predefined ordinal classification:

• Healed: Complete epithelialisation of the target wound maintained for at least 14 consecutive days.
• Improved: Reduction in target wound area >50% compared with baseline.
• Unchanged: Increase or decrease in target wound area ≤50% compared with baseline.
• Worsened: Increase in target wound area >50% compared with baseline. The target wound will be defined as the largest or clinically most relevant wound identified at baseline.

Wound healing time is defined as the number of days from the index procedure to complete epithelialisation of the target wound, without drainage or need for dressing, as assessed by the treating physician.

• Major amputation of the index limb or death prior to complete wound healing will be considered failure of the wound healing endpoint.