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Peripheral Artery Disease (PAD)NCT03744572

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

An observational study of Peripheral Artery Disease (PAD), run by Michael Lichtenberg, MD at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Artery Disease (PAD)
How many people
56 participants
Where
5 sitesGermany
Study dates
17 Oct 2018to 1 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients from clinics with vascular centers

Who may be able to join

  • Patients must be ≥ 18 years of age.
  • 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.
  • 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.
  • Patients must agree to return for all required post-index procedure follow-up visits.
  • 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.
  • Rutherford Class 4-5
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  • ≥ 70% stenosis infrapopliteal lesion by angio visual assessment (later correlated with IVUS)
  • 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).
  • 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.
  • 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.
  • 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]
  • Length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length by angio visual assessment (later correlated with IVUS)
  • At least one target lesion that is ≥ 2cm in length

Who cannot join

  • 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.
  • Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device.
  • Patients with a life expectancy, from the Investigator's opinion, of less than 2 years.
  • 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.
  • Patients with a history of Myocardial Infarction (MI), thrombolysis or angina within 30 days prior-index procedure.
  • Patients with a history of major disabling stroke within 3 months prior index procedure.
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  • Patients with any type of previous or planned surgical or interventional procedure within 15 days prior- and/or within 30 days post-index procedure.
  • Patients with a presence or history of severe renal failure (Glomerular Filtration Rate (GFR) ≤ 30 ml/min).
  • Patients who have undergone prior vascular surgery of the index limb to treat atherosclerotic disease.
  • Patients with clinically significant aneurysmal disease of the iliac, femoral or popliteal artery and patients with a history of clinically significant abdominal aortic aneurysm.
  • Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications.
  • Target vessel(s) reconstitute(s) below the ankle with no inline flow to at least one patent pedal vessel.
  • Subjects scheduled to undergo a planned major amputation
  • Prior stent placement in the target lesion(s)
  • Unsuccessful guidewire crossing
  • Subintimal guidewire placement (confirmed by IVUS, no subintimal placement is allowed)
  • Persistent inflow disease left untreated or unsuccessfully treated
  • Non ischemic ulcers and/or ulcers at or above the ankle

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Vascular Center of Klinikum Hochsauerland

    Arnsberg, 59759

  • Universitäts-Herzzentrum Bad Krozingen

    Bad Krozingen, 79189

  • SRH Klinikum Karlsbad-Langensteinbach

    Karlsbad, 76307

  • St Franziskus Hospital Münster

    Münster, 48145

  • GRN Klinik Weinheim

    Weinheim, 69469

Other trials in Germany

About this study

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

Keywords
atherectomy, Drug coated balloon
Medical subject headings
Peripheral Arterial Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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)

    Measured: 30-days

Secondary outcomes (14)

  1. Number of patients with limb salvage

    Limb salvage is defined as freedom from major amputation

    Measured: 6, 12, and 24 months

  2. 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

    Measured: 6,12, and 24 months

  3. Number of target lesions with secondary patency

    Secondary patency is defined as freedom from occluded target lesions (flow) verified by duplex ultrasound

    Measured: 6, 12 and 24 months

  4. 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

    Measured: at end of percutaneous revascularization index procedure

  5. 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

    Measured: at end of percutaneous revascularization index procedure

  6. 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

    Measured: during percutaneous revascularization index procedure post-Phoenix and before DCB treatment

  7. Wound, Ischemia, foot Infection (WIfI) Classification on target limb

    Measured: 1, 6,12 and 24 months

  8. Ankle-Brachial Index (ABI)

    Measured: 1, 6,12 and 24 months

  9. Clinical success at follow-up,

    improvement of at least one Rutherford class compared to the pre-procedure Rutherford classification

    Measured: 1, 6, 12 or 24 months

  10. 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)

    Measured: 1, 6, 12 or 24 months

  11. 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.

    Measured: 1, 6, 12 or 24 months

  12. Percentage of complete wound healing (complete epithelialization)

    Measured: 1, 6, 12 or 24 months

  13. 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

    Measured: pre- and at end of percutaneous revascularization index procedure

  14. 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

    Measured: 6, 12, or 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2018
  2. Study start17 Oct 2018
  3. Primary completion22 Dec 2020
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03744572
Sponsor's protocol ID
ASL201801
Status last verified
Jan 2023
First submitted
4 Nov 2018
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Artery Disease (PAD), run by Michael Lichtenberg, MD at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of target lesions with patency at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03744572.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.

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