Prestige Pilot - Phoenix Atherectomy and Stellarex DCB Clinical Investigation in Infrapopliteal Interventions

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 Overview

• Status: Completed
• Conditions: Peripheral Artery Disease (PAD)

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany, 59759
    • Vascular Center of Klinikum Hochsauerland
  • Bad Krozingen, Germany, 79189
    • Universitäts-Herzzentrum Bad Krozingen
  • Karlsbad, Germany, 76307
    • SRH Klinikum Karlsbad-Langensteinbach
  • Münster, Germany, 48145
    • St Franziskus Hospital Munster
  • Weinheim, Germany, 69469
    • GRN Klinik Weinheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients from clinics with vascular centers

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Michael Lichtenberg, MD
• Investigators: Principal Investigator: Michael Lichtenberg, Dr., Vascular Center, Klinikum Hochsauerland GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): December 22, 2020
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: November 4, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: atherectomy; Drug coated balloon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: ASL201801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No