Chronic Total Occlusion of Artery of the ExtremitiesWing-ItNCT03403426
ReFlow Medical Wingman Catheter Wing-IT Clinical Trial
A study testing Wingman Crossing Catheter in people with Chronic Total Occlusion of Artery of the Extremities, run by ReFlow Medical, Inc. at 1 site in United States.
Trial summary
To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Artery of the Extremities
- What is being tested?
- Wingman Crossing Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 8 Aug 2019
- 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
- Patient is willing and able to provide informed consent.
- Patient is willing and able to comply with the study protocol.
- Patient is > 18 years old.
- Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
- Patient has at least one but not more than two occluded infrainguinal arteries that are 99-100% stenosed and no flow is observed in the distal lesion except the flow from collateral circulation.
- Target lesion(s) is ≥ 1 cm and < 30 cm in length by visual estimate.
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- Target vessel is ≥ 2.0 mm in diameter.
- Patient has Rutherford Classification of 2-5.
- Lesion cannot be crossed by concurrent conventional guidewire.
- Reconstitution of vessel at least 2cm above bifurcation/trifurcation.
- Occlusion can be within previously implanted stent.
Who cannot join
- Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
- Patient has a known sensitivity or allergy to all anti-platelet medications.
- Patient is pregnant or lactating.
- Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
- Target lesion is in a bypass graft.
- Patient has had a failed crossing attempt without an intervening intervention on the target limb within the past 14 days.
- Patient has a planned surgical or interventional procedure within 30 days after the study procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Adventist St. Helena Hospital
St. Helena, California, 94574
About this study
Official title: A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries
To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.
Read the detailed description
Prospective, multi-center, non-randomized single-arm study of the Wingman Catheter to cross a single infrainguinal peripheral chronic total occlusion (CTO). Safety and effectiveness will be evaluated during the index procedure through 30-day follow-up.
- Being tested
- Wingman Crossing Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wingman Crossing CatheterDevice
Endovascular CTO crossing
| Study group | Role | What they receive |
|---|---|---|
| Wingman Crossing Catheter | Experimental | Use of the device to support CTO crossing Receives: Device: Wingman Crossing Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Lesions With Successful CTO Crossing Assessed by Angiography
While using the Wingman device, successful CTO crossing is identified by successful guidewire placement in the distal true lumen confirmed by angiography with no clinically significant perforations. Assessment by angiography with results reviewed by an independent core lab.
Measured: Intraprocedural
Major Adverse Event (MAE) Rate
Occurrence of significant in-hospital or 30-day MAEs.
Measured: Assessed from the time of the procedure through 30 days
Rate of Clinically Significant Perforations
Occurrence of clinically significant perforation, after Wingman CTO crossing and PTA of lesion, confirmed by angiography, evaluated by angiographic core lab
Measured: Will be assessed from the time of the procedure through 30 days
Secondary outcomes (7)
Lesion Success
Lesion success, defined as attainment of <50% final residual stenosis of the target lesion using any percutaneous method
Measured: Intraprocedural
Procedure Success Rate
Procedure success, defined as device success and the absence of in-hospital MAEs, clinically significant perforation, clinically significant embolization or Grade C or greater dissection not resolved by visual estimate
Measured: Approximately 24 hours post procedure
Incidence of In-hospital AE or MAE
Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device
Measured: Intraprocedural
Total Procedural Time
Evaluation of total procedural time
Measured: Approximately 24 hours post procedure
Device Procedural Time
Evaluation of procedure time associated with use of the investigational device.
Measured: Approximately 24 hours post procedure
Contrast Use
Evaluation of total procedural contrast volume use
Measured: Approximately 24 hours post procedure
Fluoroscopic Time
Evaluation of total procedural fluoroscopic time
Measured: Approximately 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start13 Feb 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
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 Chronic Total Occlusion of Artery of the ExtremitiesStudies 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReFlow Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Laird, MD, Principal investigator, Adventist St. Helena Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403426
- Sponsor's protocol ID
- RFM-CTO-13001
- Acronym
- Wing-It
- Status last verified
- Jan 2021
- First submitted
- 29 Nov 2017
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries
- ClinicalTrials.gov ID
- NCT03403426
- Acronym / sponsor ID
- Wing-It / RFM-CTO-13001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- ReFlow Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.
Detailed description
Prospective, multi-center, non-randomized single-arm study of the Wingman Catheter to cross a single infrainguinal peripheral chronic total occlusion (CTO). Safety and effectiveness will be evaluated during the index procedure through 30-day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wingman Crossing Catheter | Experimental | Device: Wingman Crossing CatheterUse of the device to support CTO crossing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is willing and able to provide informed consent.
- Patient is willing and able to comply with the study protocol.
- Patient is > 18 years old.
- Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
- Patient has at least one but not more than two occluded infrainguinal arteries that are 99-100% stenosed and no flow is observed in the distal lesion except the flow from collateral circulation.
Key exclusion criteria (7 listed)
- Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
- Patient has a known sensitivity or allergy to all anti-platelet medications.
- Patient is pregnant or lactating.
- Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
- Target lesion is in a bypass graft.
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 |
|---|---|---|
| Wingman Crossing CatheterEndovascular CTO crossing | Device | Wingman Crossing Catheter |
Primary outcome
Number of Lesions With Successful CTO Crossing Assessed by Angiography
Time frame: Intraprocedural
While using the Wingman device, successful CTO crossing is identified by successful guidewire placement in the distal true lumen confirmed by angiography with no clinically significant perforations. Assessment by angiography with results reviewed by an independent core lab.
Major Adverse Event (MAE) Rate
Time frame: Assessed from the time of the procedure through 30 days
Occurrence of significant in-hospital or 30-day MAEs.
Rate of Clinically Significant Perforations
Time frame: Will be assessed from the time of the procedure through 30 days
Occurrence of clinically significant perforation, after Wingman CTO crossing and PTA of lesion, confirmed by angiography, evaluated by angiographic core lab
7 secondary outcomes
Lesion Success
Time frame: Intraprocedural
Procedure Success Rate
Time frame: Approximately 24 hours post procedure
Incidence of In-hospital AE or MAE
Time frame: Intraprocedural
Total Procedural Time
Time frame: Approximately 24 hours post procedure
Device Procedural Time
Time frame: Approximately 24 hours post procedure
Contrast Use
Time frame: Approximately 24 hours post procedure
Fluoroscopic Time
Time frame: Approximately 24 hours post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Total Occlusion of Artery of the Extremities
Recruiting
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
Chronic Total Occlusion of Artery of the Extremities
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.
John Laird, MD principal investigator
Adventist St. Helena Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wingman Crossing Catheter in people with Chronic Total Occlusion of Artery of the Extremities, run by ReFlow Medical, Inc. at 1 site in United States.
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 7 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 7 Jan 2021. 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 United States. 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 7 Jan 2021). 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?
Number of Lesions With Successful CTO Crossing Assessed by Angiography (time frame: Intraprocedural). The study lists 3 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 7 Jan 2021.