An interventional study of Wingman Crossing Catheter in Chronic Total Occlusion of Artery of the Extremities, sponsored by ReFlow Medical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-07.
Sponsored by ReFlow Medical, Inc. · Not applicable, Interventional, and Treatment
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.
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.
ReFlow Medical, Inc. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of the device to support CTO crossing
Device: Wingman Crossing Catheter
Endovascular CTO crossing
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.
Time frame: Intraprocedural
Major Adverse Event (MAE) Rate
Occurrence of significant in-hospital or 30-day MAEs.
Time frame: 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
Time frame: Will be assessed from the time of the procedure through 30 days
Lesion Success
Lesion success, defined as attainment of \<50% final residual stenosis of the target lesion using any percutaneous method
Time frame: 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
Time frame: 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
Time frame: Intraprocedural
Total Procedural Time
Evaluation of total procedural time
Time frame: Approximately 24 hours post procedure
Device Procedural Time
Evaluation of procedure time associated with use of the investigational device.
Time frame: Approximately 24 hours post procedure
Contrast Use
Evaluation of total procedural contrast volume use
Time frame: Approximately 24 hours post procedure
Fluoroscopic Time
Evaluation of total procedural fluoroscopic time
Time frame: Approximately 24 hours post procedure
| Milestone | Wingman Crossing Catheter |
|---|---|
| Started | 85 |
| Completed | 82 |
| Not completed | 3 |
| Withdrew: Death | 1 |
| Withdrew: Lost to follow-up | 2 |
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.
| lesions | Wingman Crossing Catheter |
|---|---|
| Number of Lesions With Successful CTO Crossing Assessed by Angiography | 77 |
Occurrence of significant in-hospital or 30-day MAEs.
| Participants | Wingman Crossing Catheter |
|---|---|
| Major Adverse Event (MAE) Rate | 4 |
Occurrence of clinically significant perforation, after Wingman CTO crossing and PTA of lesion, confirmed by angiography, evaluated by angiographic core lab
| Participants | Wingman Crossing Catheter |
|---|---|
| Rate of Clinically Significant Perforations | 1 |
Lesion success, defined as attainment of \<50% final residual stenosis of the target lesion using any percutaneous method
| Lesions | Wingman Crossing Catheter |
|---|---|
| Lesion Success | 77 |
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
| Participants | Wingman Crossing Catheter |
|---|---|
| Procedure Success Rate | 75 |
Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device
| Participants | Wingman Crossing Catheter |
|---|---|
| Incidence of In-hospital AE or MAE | 16 |
Evaluation of total procedural time
| minutes | Wingman Crossing Catheter |
|---|---|
| Total Procedural Time | 102 ± 48 |
Evaluation of procedure time associated with use of the investigational device.
| minutes | Wingman Crossing Catheter |
|---|---|
| Device Procedural Time | 12 ± 12 |
Evaluation of total procedural contrast volume use
| mL | Wingman Crossing Catheter |
|---|---|
| Contrast Use | 148 ± 79 |
Evaluation of total procedural fluoroscopic time
| minutes | Wingman Crossing Catheter |
|---|---|
| Fluoroscopic Time | 30 ± 18 |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wingman Crossing Catheter | 1/85 (1.2%) | 22/85 (25.9%) | 21/85 (24.7%) |
| Event | Wingman Crossing Catheter |
|---|---|
| Peripheral artery occlusionVascular disorders | 4/85 |
| Vascular pseudoaneurysmInjury, poisoning and procedural complications | 3/85 |
| Vascular access site dissectionGeneral disorders | 2/85 |
| PneumoniaInfections and infestations | 2/85 |
| Vessel perforationInjury, poisoning and procedural complications | 2/85 |
| Acute left ventricular failureCardiac disorders | 1/85 |
| Cardiac failure congestiveCardiac disorders | 1/85 |
| Atrial fibrillationCardiac disorders | 1/85 |
| Ventricular fibrillationCardiac disorders | 1/85 |
| Procedural vomitingGastrointestinal disorders | 1/85 |
| Event | Wingman Crossing Catheter |
|---|---|
| Vascular access site dissectionGeneral disorders | 10/85 |
| Vascular access site haematomaGeneral disorders | 7/85 |
| Peripheral embolismVascular disorders | 7/85 |
| Age, Continuous(years) | Wingman Crossing Catheter |
|---|---|
| Mean | 71.4 ± 9.3 |
| Sex: Female, Male(Participants) | Wingman Crossing Catheter |
|---|---|
| Female | 29 |
| Male | 56 |
| Ethnicity (NIH/OMB)(Participants) | Wingman Crossing Catheter |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 84 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Wingman Crossing Catheter |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 78 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Wingman Crossing Catheter |
|---|---|
| United States | 59 |
| Austria | 15 |
| Germany | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Aug 2019, 17 months.
Results were first posted in Jan 2021, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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ReFlow Medical, Inc.