ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease

ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease- a Multi-center Experience in 80 Subsequent Patients

The purpose of this single-arm, exploratory study is to evaluate safety and performance of treatment of critical limb ischemia (CLI) with the ULTRASCORE™ Focused Force balloon.

Patients with CLI in below the knee vessels will receive a percutaneous transluminal angioplasty with the device and will be followed up for 12 months.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease (PAD)
• Intervention / Treatment: Device: ULTRASCORE™ Focused Force PTA Balloon

Detailed Description

This single-arm, prospective, multi-center CE marked study (IIT) is planned to include up to 80 subjects with CLI in below the knee vessels with de novo stenoses or non-stented re-stenotic in total greater or equal 70% stenosis or occlusion of lower limb lesion. During the index procedure at Day 1 patients will be treated with ULTRASCORE™ Focused Force balloon.

Follow-up investigations for evaluation of parameters for primary and secondary endpoints will be performed at 4 weeks, 6 months, and 12 months after the index procedure..

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany, 59759
    • Recruiting
    • Klinikum Hochsauerland, Karolinen-Hospital
    • Contact: Michael Lichtenberg, Dr. med. Dr. oec. med.; Phone Number: 201 +49 (0)2932 952 242; Email: M.Lichtenberg@klinikum-hochsauerland.de

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 of lower limb lesion by angio visual assessment
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 re-stenotic (stenosis ≥ 70% or occlusion by visual estimate). If the target lesion is re-stenotic, 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 ≤ 30 cm
11. 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 a presence or history of severe renal failure (Glomerular Filtration Rate (GFR) ≤ 25 ml/min).
8. Patients who have undergone prior vascular surgery of the index limb to treat atherosclerotic disease.
9. Patients with clinically significant aneurysmal disease of the iliac, femoral or popliteal artery and patients with a history of clinically significant abdominal aortic aneurysm.
10. Target vessel(s) reconstitute(s) below the ankle with no inline flow to at least one patent pedal vessel.
11. Subjects scheduled to undergo a planned major amputation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ULTRASCORE™ Focused Force PTA Balloon	Device: ULTRASCORE™ Focused Force PTA Balloon; The device will be used for percutaneous transluminal angioplasty (PTA) to dilatate calcified stenoses in below the knee vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with patency of target lesion	Patency is defined as freedom from occluded target lesions (flow) verified by duplex ultrasound without re-intervention	12 months
Number of patients with composite safety	Freedom from major adverse limb events (MALE) and / or perioperative death	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with patency measured with PSVR	freedom from >50% restenosis in the target lesion as indicated by a duplex ultrasound peak systolic velocity ratio (PSVR) <2.5	1, 6 and 12 months
Number of patients with secondary patency	freedom from occluded target lesions (flow) verified by duplex ultrasound	6 and 12 months
Number of patients with MAE (major adverse events) and MALE (Major adverse limb events)	composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and clinically driven TLR	1 , 6 and 12 months
Number of patients with procedural success	≤30% diameter stenose (DS) as determined by visual assessment	Day 1 after the index procedure
Number of patients with Device Success	≤30% diameter stenose (DS) with no remaining flow limiting dissection as determined by visual assessment	Day 1 post Ultrascore usage
Ankle-Brachial Index (ABI)		6 and 12 months
Number of patients with Clinical success	improvement of at least one Rutherford class compared to the pre-procedure Rutherford classification	6 and 12 months
Number of patients with freedom from Target Lesion Revascularisation (TLR)		6 and 12 months
Number of patients with freedom from Target Vessel Revascularisation (TVR)		6 and 12 months
Number of patients with freedom from minor amputation		6 and 12 months
Comparison of pain rating scale scores to Baseline	pain rating scale from 0 (no pain) to 10 (worst pain)	6 and 12 months
Comparison of the scores on the Walking Impairment Questionnaire (WIQ) to Baseline	individual scores for questions in the WIQ assessing the difficulties ranging from none (4) to not possible (0), Higher scores indicate a better outcome.	6 and 12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Scoring balloon dilatation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: ASL202001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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