Clinical trial NCT03744572: Prestige Pilot - Phoenix Atherectomy and Stellarex DCB Clinical Investigation in Infrapopliteal Interventions
Official title: Prestige Pilot - Phoenix Atherectomy and Stellarex DCB Clinical Investigation in Infrapopliteal Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease (PAD)
Keywords: atherectomy
Drug coated balloon
Lead sponsor: Klinikum Arnsberg
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients from clinics with vascular centers

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of target lesions with patency at 6 months
timeFrame: 6 months
measure: Composite Safety; Number of patients with freedom from BTK major adverse limb events (MALE) and/or perioperative death (POD)
timeFrame: 30-days
Secondary outcomes:
measure: Number of patients with limb salvage
timeFrame: 6, 12, and 24 months
measure: Number of target lesions with patency as indicated by PSVR measurement
timeFrame: 6,12, and 24 months
measure: Number of target lesions with secondary patency
timeFrame: 6, 12 and 24 months
measure: Number of target lesions with procedural success
timeFrame: at end of percutaneous revascularization index procedure
measure: Number of target lesions with technical success
timeFrame: at end of percutaneous revascularization index procedure
measure: Number of target lesions with device success for Phoenix atherectomy
timeFrame: during percutaneous revascularization index procedure post-Phoenix and before DCB treatment
measure: Wound, Ischemia, foot Infection (WIfI) Classification on target limb
timeFrame: 1, 6,12 and 24 months
measure: Ankle-Brachial Index (ABI)
timeFrame: 1, 6,12 and 24 months
measure: Clinical success at follow-up,
timeFrame: 1, 6, 12 or 24 months
measure: Pain rating scale scores compared to Baseline
timeFrame: 1, 6, 12 or 24 months
measure: Walking Impairment Questionnaire (WIQ) score compared to Baseline
timeFrame: 1, 6, 12 or 24 months
measure: Percentage of complete wound healing (complete epithelialization)
timeFrame: 1, 6, 12 or 24 months
measure: correlation between IVUS metrics and angiographic core lab assessment
timeFrame: pre- and at end of percutaneous revascularization index procedure
measure: Number of patients without Major Adverse Event (MAE)
timeFrame: 6, 12, or 24 months
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Vascular Center of Klinikum Hochsauerland
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Bad Krozingen
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach
city: Münster
country: Germany
facility: St Franziskus Hospital Münster
city: Weinheim
country: Germany
facility: GRN Klinik Weinheim
Study officials:
affiliation: Vascular Center, Klinikum Hochsauerland GmbH
name: Michael Lichtenberg, Dr.
role: PRINCIPAL_INVESTIGATOR
References: