This pilot study is to investigate if a lesion preparation strategy with Phoenix atherectomy before DCB (drug coated balloon) usage in patients with PAD (peripheral artery disease) Rutherford Stage 4-5 and mild/moderate/severe calcium can improve outcomes including patency and limb salvage and evaluate safety and performance of the combination therapy
Study Type
OBSERVATIONAL
Enrollment
56
Vascular Center of Klinikum Hochsauerland
Arnsberg, Germany
Universitäts-Herzzentrum Bad Krozingen
Bad Krozingen, Germany
SRH Klinikum Karlsbad-Langensteinbach
Karlsbad, Germany
St Franziskus Hospital Münster
Münster, Germany
Number of target lesions with patency at 6 months
Patency defined as freedom from occluded target lesions (flow) verified by duplex ultrasound without re-intervention
Time frame: 6 months
Composite Safety; Number of patients with freedom from BTK major adverse limb events (MALE) and/or perioperative death (POD)
Freedom from BTK major adverse limb events (MALE) and/or perioperative death (POD)
Time frame: 30-days
Number of patients with limb salvage
Limb salvage is defined as freedom from major amputation
Time frame: 6, 12, and 24 months
Number of target lesions with patency as indicated by PSVR measurement
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 reintervention
Time frame: 6,12, and 24 months
Number of target lesions with secondary patency
Secondary patency is defined as freedom from occluded target lesions (flow) verified by duplex ultrasound
Time frame: 6, 12 and 24 months
Number of target lesions with procedural success
Procedural sucess is defined as achievement of a ≤30% Diameter Stenosis (DS) at the end of the procedure without MAEs as determined by angiographic core lab
Time frame: at end of percutaneous revascularization index procedure
Number of target lesions with technical success
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GRN Klinik Weinheim
Weinheim, Germany
Technical sucess is defined as achievement of a ≤30% Diameter Stenosis (DS) following Phoenix and DCB as determined by angiographic core lab
Time frame: at end of percutaneous revascularization index procedure
Number of target lesions with device success for Phoenix atherectomy
Device success is defined as achievement of a ≤50% Diameter Stenosis (DS) post-Phoenix without pre-dilatation and before DCB or any adjunctive therapy as determined by angiographic core lab
Time frame: during percutaneous revascularization index procedure post-Phoenix and before DCB treatment
Wound, Ischemia, foot Infection (WIfI) Classification on target limb
Time frame: 1, 6,12 and 24 months
Ankle-Brachial Index (ABI)
Time frame: 1, 6,12 and 24 months
Clinical success at follow-up,
improvement of at least one Rutherford class compared to the pre-procedure Rutherford classification
Time frame: 1, 6, 12 or 24 months
Pain rating scale scores compared to Baseline
Pain in the legs during the last 24 h rated on a numerical scale from 0 (no pain) to 10 (worst possible pain)
Time frame: 1, 6, 12 or 24 months
Walking Impairment Questionnaire (WIQ) score compared to Baseline
The total WIQ score is defined as sum of five subscores. A subscore is calculated as sum of a scale for each of five separate domains.
Time frame: 1, 6, 12 or 24 months
Percentage of complete wound healing (complete epithelialization)
Time frame: 1, 6, 12 or 24 months
correlation between IVUS metrics and angiographic core lab assessment
Core lab assessed correlation between IVUS metrics of true luminal diameter, actual % area stenosis, change in plaque area and luminal gain pre- and post-therapy, plaque shape and angiographic core lab assessment of pre- and post-percent diameter stenosis (%DS) and the extent of vascular calcification will be determined
Time frame: pre- and at end of percutaneous revascularization index procedure
Number of patients without Major Adverse Event (MAE)
MAEs defined as clinically-driven target lesion revascularization, major amputation of the treated limb, and all-cause death
Time frame: 6, 12, or 24 months