Peripheral Arterial Disease (PAD)NCT04631848
ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease
An observational study of Peripheral Arterial Disease (PAD), run by Michael Lichtenberg, MD at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease (PAD)
- What is being tested?
- ULTRASCORE™ Focused Force PTA Balloon
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 23 Oct 2020to May 2023
- 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 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
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 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Hochsauerland, Karolinen-Hospital
Arnsberg, 59759
Michael Lichtenberg, Dr. med. Dr. oec. med., +49 (0)2932 952 242 ext. 201, M.Lichtenberg@klinikum-hochsauerland.de
About this study
Official title: 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.
Read the 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..
- Conditions
- Peripheral Arterial Disease (PAD)
- Being tested
- ULTRASCORE™ Focused Force PTA Balloon
- Keywords
- Scoring balloon dilatation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRASCORE™ Focused Force PTA BalloonDevice
The device will be used for percutaneous transluminal angioplasty (PTA) to dilatate calcified stenoses in below the knee vessels
| Study group | Role | What they receive |
|---|---|---|
| ULTRASCORE™ Focused Force PTA Balloon | Not described Receives: Device: ULTRASCORE™ Focused Force PTA Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Number of patients with composite safety
Freedom from major adverse limb events (MALE) and / or perioperative death
Measured: 4 weeks
Secondary outcomes (12)
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
Measured: 1, 6 and 12 months
Number of patients with secondary patency
freedom from occluded target lesions (flow) verified by duplex ultrasound
Measured: 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
Measured: 1 , 6 and 12 months
Number of patients with procedural success
≤30% diameter stenose (DS) as determined by visual assessment
Measured: 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
Measured: Day 1 post Ultrascore usage
Ankle-Brachial Index (ABI)
Measured: 6 and 12 months
Number of patients with Clinical success
improvement of at least one Rutherford class compared to the pre-procedure Rutherford classification
Measured: 6 and 12 months
Number of patients with freedom from Target Lesion Revascularisation (TLR)
Measured: 6 and 12 months
Number of patients with freedom from Target Vessel Revascularisation (TVR)
Measured: 6 and 12 months
Number of patients with freedom from minor amputation
Measured: 6 and 12 months
Comparison of pain rating scale scores to Baseline
pain rating scale from 0 (no pain) to 10 (worst pain)
Measured: 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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start23 Oct 2020
- Primary completionDec 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease (PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Lichtenberg, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Lichtenberg, MD, Klinikum Arnsberg
- Investigators
- Michael Lichtenberg, Dr. med., Principal investigator, Klinikum Hochsauerland GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631848
- Sponsor's protocol ID
- ASL202001
- Status last verified
- Mar 2022
- First submitted
- 6 Nov 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease- a Multi-center Experience in 80 Subsequent Patients
- ClinicalTrials.gov ID
- NCT04631848
- Acronym / sponsor ID
- ASL202001
- Conditions
- Peripheral Arterial Disease (PAD)
- Keywords
- Scoring balloon dilatation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Michael Lichtenberg, MDUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ULTRASCORE™ Focused Force PTA Balloon | – | Device: ULTRASCORE™ Focused Force PTA Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from clinics with vascular centers
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ULTRASCORE™ Focused Force PTA BalloonThe device will be used for percutaneous transluminal angioplasty (PTA) to dilatate calcified stenoses in below the knee vessels | Device | ULTRASCORE™ Focused Force PTA Balloon |
Primary outcome
Number of patients with patency of target lesion
Time frame: 12 months
Patency is defined as freedom from occluded target lesions (flow) verified by duplex ultrasound without re-intervention
Number of patients with composite safety
Time frame: 4 weeks
Freedom from major adverse limb events (MALE) and / or perioperative death
12 secondary outcomes
Number of patients with patency measured with PSVR
Time frame: 1, 6 and 12 months
Number of patients with secondary patency
Time frame: 6 and 12 months
Number of patients with MAE (major adverse events) and MALE (Major adverse limb events)
Time frame: 1 , 6 and 12 months
Number of patients with procedural success
Time frame: Day 1 after the index procedure
Number of patients with Device Success
Time frame: Day 1 post Ultrascore usage
Ankle-Brachial Index (ABI)
Time frame: 6 and 12 months
Number of patients with Clinical success
Time frame: 6 and 12 months
Number of patients with freedom from Target Lesion Revascularisation (TLR)
Time frame: 6 and 12 months
Number of patients with freedom from Target Vessel Revascularisation (TVR)
Time frame: 6 and 12 months
Number of patients with freedom from minor amputation
Time frame: 6 and 12 months
Comparison of pain rating scale scores to Baseline
Time frame: 6 and 12 months
Comparison of the scores on the Walking Impairment Questionnaire (WIQ) to Baseline
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klinikum Hochsauerland, Karolinen-Hospital
Arnsberg, Germany
Michael Lichtenberg, Dr. med. principal investigator
Klinikum Hochsauerland GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease (PAD), run by Michael Lichtenberg, MD at 1 site 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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with patency of target lesion (time frame: 12 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?
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 31 Mar 2022.