Peripheral Artery Disease (PAD)
Conditions
Keywords
atherectomy, Drug coated balloon
Brief summary
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
Interventions
None listed
Sponsors
Michael Lichtenberg, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must be ≥ 18 years of age. 2. Patients are male or, if female, are either not of childbearing potential or must have a negative pregnancy test done within 7 days prior-index procedure and effective contraception must be used during participation in the Clinical Investigation. 3. Patients who are mentally and linguistically able to understand the aim of the Clinical Investigation and to show sufficient compliance in following the Clinical Investigation Plan. 4. Patients must agree to return for all required post-index procedure follow-up visits. 5. Patients are able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of the Clinical Investigation. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document. 6. Rutherford Class 4-5 7. ≥ 70% stenosis infrapopliteal lesion by angio visual assessment (later correlated with IVUS) 8. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent pedal vessel (includes perforating peroneal branches to dorsalis pedis and plantar artery). 9. The target lesion must either be de-novo or restenotic (stenosis ≥ 70% or occlusion by visual estimate). If the target lesion is restenotic, the prior PTA must have been done \> 30 days prior-index procedure. 10. Treatment of multiple target lesions is allowed, as long as the composite target lesion length is ≤ 27 cm and the target lesions can be treated with a maximum of 2 overlapping Investigational Devices. 11. Presence of clearly visible calcification in two views (both sides of vessel at the same location) evaluated angiographically- \[OPTIONAL: Computerized tomography (CT) angio images may substitute to confirm distribution of calcium, if available as standard of care\] 12. Length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length by angio visual assessment (later correlated with IVUS) 13. At least one target lesion that is ≥ 2cm in length
Exclusion criteria
1. Patients with a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or other anticoagulant/anti-platelet therapies, Paclitaxel (or analogs) or sensitivity to contrast media that cannot be adequately premedicated. 2. Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device. 3. Patients with a life expectancy, from the Investigator's opinion, of less than 2 years. 4. Patients that are currently participating in other clinical investigations involving any investigational drug or device that may potentially confound the results of the Clinical Investigation, or that would limit the patient's compliance with the follow-up requirements of the Clinical Investigation. 5. Patients with a history of Myocardial Infarction (MI), thrombolysis or angina within 30 days prior-index procedure. 6. Patients with a history of major disabling stroke within 3 months prior index procedure. 7. Patients with any type of previous or planned surgical or interventional procedure within 15 days prior- and/or within 30 days post-index procedure. 8. Patients with a presence or history of severe renal failure (Glomerular Filtration Rate (GFR) ≤ 30 ml/min). 9. Patients who have undergone prior vascular surgery of the index limb to treat atherosclerotic disease. 10. Patients with clinically significant aneurysmal disease of the iliac, femoral or popliteal artery and patients with a history of clinically significant abdominal aortic aneurysm. 11. Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications. 12. Target vessel(s) reconstitute(s) below the ankle with no inline flow to at least one patent pedal vessel. 13. Subjects scheduled to undergo a planned major amputation 14. Prior stent placement in the target lesion(s) 15. Unsuccessful guidewire crossing 16. Subintimal guidewire placement (confirmed by IVUS, no subintimal placement is allowed) 17. Persistent inflow disease left untreated or unsuccessfully treated 18. Non ischemic ulcers and/or ulcers at or above the ankle
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of target lesions with patency at 6 months | 6 months | Patency defined as freedom from occluded target lesions (flow) verified by duplex ultrasound without re-intervention |
| Composite Safety; Number of patients with freedom from BTK major adverse limb events (MALE) and/or perioperative death (POD) | 30-days | Freedom from BTK major adverse limb events (MALE) and/or perioperative death (POD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of target lesions with secondary patency | 6, 12 and 24 months | Secondary patency is defined as freedom from occluded target lesions (flow) verified by duplex ultrasound |
| Number of target lesions with procedural success | at end of percutaneous revascularization index procedure | 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 |
| Number of target lesions with technical success | at end of percutaneous revascularization index procedure | Technical sucess is defined as achievement of a ≤30% Diameter Stenosis (DS) following Phoenix and DCB as determined by angiographic core lab |
| Number of target lesions with device success for Phoenix atherectomy | during percutaneous revascularization index procedure post-Phoenix and before DCB treatment | 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 |
| 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 | — |
| Number of patients with limb salvage | 6, 12, and 24 months | Limb salvage is defined as freedom from major amputation |
| Pain rating scale scores compared to Baseline | 1, 6, 12 or 24 months | Pain in the legs during the last 24 h rated on a numerical scale from 0 (no pain) to 10 (worst possible pain) |
| Walking Impairment Questionnaire (WIQ) score compared to Baseline | 1, 6, 12 or 24 months | 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. |
| Percentage of complete wound healing (complete epithelialization) | 1, 6, 12 or 24 months | — |
| correlation between IVUS metrics and angiographic core lab assessment | pre- and at end of percutaneous revascularization index procedure | 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 |
| Number of patients without Major Adverse Event (MAE) | 6, 12, or 24 months | MAEs defined as clinically-driven target lesion revascularization, major amputation of the treated limb, and all-cause death |
| Clinical success at follow-up, | 1, 6, 12 or 24 months | improvement of at least one Rutherford class compared to the pre-procedure Rutherford classification |
| Number of target lesions with patency as indicated by PSVR measurement | 6,12, and 24 months | 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 |
Countries
Germany
Outcome results
None listed