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

NCT ID: NCT03744572

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2022-06-01

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael Lichtenberg, MD

OTHER

Sponsor Role: lead

Responsible Party

Michael Lichtenberg, MD

Chief medical officer Vascular Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Lichtenberg, Dr.

Role: PRINCIPAL_INVESTIGATOR

Vascular Center, Klinikum Hochsauerland GmbH

Locations

Vascular Center of Klinikum Hochsauerland

Arnsberg, , Germany

Universitäts-Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad, , Germany

St Franziskus Hospital Münster

Münster, , Germany

GRN Klinik Weinheim

Weinheim, , Germany

Countries

Germany

Other Identifiers

ASL201801

Identifier Type: -

Identifier Source: org_study_id