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

NCT04631848 | Unknown

• 1 other identifier: ASL202001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Arterial Disease (PAD)

Keywords

Scoring balloon dilatation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Number of patients with patency measured with PSVR

  1, 6 and 12 months

• Number of patients with secondary patency

  6 and 12 months

• Number of patients with MAE (major adverse events) and MALE (Major adverse limb events)

  1 , 6 and 12 months

• Number of patients with procedural success

  Day 1 after the index procedure

• Number of patients with Device Success

  Day 1 post Ultrascore usage

Study Arms (1)

ULTRASCORE™ Focused Force PTA Balloon

Device: ULTRASCORE™ Focused Force PTA Balloon

Interventions

ULTRASCORE™ Focused Force PTA Balloon DEVICE

The device will be used for percutaneous transluminal angioplasty (PTA) to dilatate calcified stenoses in below the knee vessels

ULTRASCORE™ Focused Force PTA Balloon

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 of lower limb lesion by angio visual assessment
• 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 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.
• Treatment of multiple target lesions is allowed, as long as the composite target lesion length is ≤ 30 cm
• 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 a presence or history of severe renal failure (Glomerular Filtration Rate (GFR) ≤ 25 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.
• 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

Sponsors & Collaborators

• Michael Lichtenberg, MD: lead

Study Sites (1)

Klinikum Hochsauerland, Karolinen-Hospital

Arnsberg, 59759, Germany

RECRUITING

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. med.

  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 6, 2020
• First Posted: November 17, 2020
• Study Start: October 23, 2020
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)