Peripheral Arterial Disease (PAD)WISE-LENCT02780349
Evaluation of WIRION™ EPS in Lower Extremities Arteries
A study testing WIRION in people with Peripheral Arterial Disease (PAD), run by Gardia Medical at 10 sites in 2 countries.
Trial summary
Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD) 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?
- WIRION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 10 sitesin 2 countries
- Study dates
- May 2016to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subject is at least 18 years of age
- Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures
- Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
- Rutherford classification 2-4
- Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries
- Planned atherectomy of the native femoropopliteal arteries
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- Reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm
- An adequate "landing zone" for placement of the WIRION™ device distal to the target lesion of at least 30mm
- A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study
Who cannot join
- Any planned surgical or endovascular intervention within 30 days before or after the index procedure
- A lesion deemed not accessible by the WIRION™ EPS
- Inability to take aspirin or ADP receptor antagonists
- History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary
- Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment
- Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded)
Show all 9Show fewer
- Life expectancy less than 12 months
- Known severe renal insufficiency (eGFR <30 ml/min/1.72m2).
- ≤1-vessel tibial run-off status
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
St Elizabeth Medical Center
Boston, Massachusetts, 02135
Unity Point
Davenport, Iowa
Denver VA Medical Center
Denver, Colorado, 80220
St John Hospital
Detroit, Michigan, 48236
Ochsner Clinic
New Orleans, Louisiana
Columbia Presbyterian
New York, New York
Lankenau Institute for Medical Research
Philadelphia, Pennsylvania, 19096
Miriam Hospital
Providence, Rhode Island, 02906
Germany2 sites
Universitats herzzentrum Bad Krozingen
Bad Krozingen, 79189
Universitatklinikum Leipzig
Leipzig, 04103
About this study
Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)
- Conditions
- Peripheral Arterial Disease (PAD)
- Being tested
- WIRION
- 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.
WIRIONDevice
Embolic Protection System
| Study group | Role | What they receive |
|---|---|---|
| WIRION EPS | Experimental | Single arm study. All patients undergo procedure with the WIRION EPS Receives: Device: WIRION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.
MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startMay 2016
- Primary completion30 Aug 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gardia Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Gray, MD, Principal investigator, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780349
- Sponsor's protocol ID
- CL-003
- Acronym
- WISE-LE
- Status last verified
- Feb 2018
- First submitted
- 19 May 2016
- Last updated
- 15 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of WIRION™ EPS in Lower Extremities Arteries
- ClinicalTrials.gov ID
- NCT02780349
- Acronym / sponsor ID
- WISE-LE / CL-003
- Conditions
- Peripheral Arterial Disease (PAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Gardia MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Posted 14 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WIRION EPS | Experimental | Device: WIRIONSingle arm study. All patients undergo procedure with the WIRION EPS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is at least 18 years of age
- Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures
- Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
- Rutherford classification 2-4
- Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries
Key exclusion criteria (9 listed)
- Any planned surgical or endovascular intervention within 30 days before or after the index procedure
- A lesion deemed not accessible by the WIRION™ EPS
- Inability to take aspirin or ADP receptor antagonists
- History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary
- Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment
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 |
|---|---|---|
| WIRIONEmbolic Protection System | Device | WIRION EPS |
Primary outcome
Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.
Time frame: 30 days
MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
William Gray, MD principal investigator
Main Line Health
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WIRION in people with Peripheral Arterial Disease (PAD), run by Gardia Medical at 10 sites in 2 countries.
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 9 inclusion and 9 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: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, 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?
Yes. Results are posted in the registry (first posted 14 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure. (time frame: 30 days). 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 15 Mar 2018.