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

NCT03744572 | Completed

• 1 other identifier: ASL201801
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 5

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

Conditions

Peripheral Artery Disease (PAD)

Keywords

atherectomy; Drug coated balloon

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Number of patients with limb salvage

  6, 12, and 24 months

• Number of target lesions with patency as indicated by PSVR measurement

  6,12, and 24 months

• Number of target lesions with secondary patency

  6, 12 and 24 months

• Number of target lesions with procedural success

  at end of percutaneous revascularization index procedure

• Number of target lesions with technical success

  at end of percutaneous revascularization index procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients from clinics with vascular centers

You may qualify if:

• 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
• ≥ 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Michael Lichtenberg, MD: lead

Study Sites (5)

Vascular Center of Klinikum Hochsauerland

Arnsberg, 59759, Germany

Location

Universitäts-Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad, 76307, Germany

Location

St Franziskus Hospital Münster

Münster, 48145, Germany

Location

GRN Klinik Weinheim

Weinheim, 69469, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Michael Lichtenberg, Dr.

  Vascular Center, Klinikum Hochsauerland GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief medical officer Vascular Center

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 16, 2018
• Study Start: October 17, 2018
• Primary Completion: December 22, 2020
• Study Completion: June 1, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

DE (5)