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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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 30-days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with limb salvage | Limb salvage is defined as freedom from major amputation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients from clinics with vascular centers
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lichtenberg, Dr. | Vascular Center, Klinikum Hochsauerland GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Center of Klinikum Hochsauerland | Arnsberg | 59759 | Germany | |||
| Universitäts-Herzzentrum Bad Krozingen |
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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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| 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 | 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 | at end of percutaneous revascularization index procedure |
| Number of target lesions with technical success | Technical sucess is defined as achievement of a ≤30% Diameter Stenosis (DS) following Phoenix and DCB as determined by angiographic core lab | 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 | during percutaneous revascularization index procedure post-Phoenix and before DCB treatment |
| Wound, Ischemia, foot Infection (WIfI) Classification on target limb | 1, 6,12 and 24 months |
| Ankle-Brachial Index (ABI) | 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 | 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) | 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. | 1, 6, 12 or 24 months |
| Percentage of complete wound healing (complete epithelialization) | 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 | 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 | 6, 12, or 24 months |
| Bad Krozingen |
| 79189 |
| Germany |
| SRH Klinikum Karlsbad-Langensteinbach | Karlsbad | 76307 | Germany |
| St Franziskus Hospital Münster | Münster | 48145 | Germany |
| GRN Klinik Weinheim | Weinheim | 69469 | Germany |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |