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ReFlow Medical Wingman Catheter Wing-IT Clinical Trial
NA trial testing Wingman Crossing Catheter in Chronic Total Occlusion of Artery of the Extremities in 85 participants. Completed in 8 August 2019.
| Lead sponsor | ReFlow Medical, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 85 |
| Start date | 13 February 2018 |
| Primary completion | 8 August 2019 |
| Estimated completion | 8 August 2019 |
| Sites | 1 location across United States |
ReFlow Medical, Inc. — full company profile →
18 and older, any sex, with Chronic Total Occlusion of Artery of the Extremities. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 77 |
Occurrence of significant in-hospital or 30-day MAEs.
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 4 |
Occurrence of clinically significant perforation, after Wingman CTO crossing and PTA of lesion, confirmed by angiography, evaluated by angiographic core lab
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 1 |
Lesion success, defined as attainment of \<50% final residual stenosis of the target lesion using any percutaneous method
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 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
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 75 |
Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 16 |
Evaluation of total procedural time
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 102 | ± 48 |
Evaluation of procedure time associated with use of the investigational device.
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 12 | ± 12 |
Evaluation of total procedural contrast volume use
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 148 | ± 79 |
Evaluation of total procedural fluoroscopic time
| Group | Value | 95% CI |
|---|---|---|
| Wingman Crossing Catheter | 30 | ± 18 |
Time frame: 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Wingman Crossing Catheter |
|---|---|---|
| Peripheral artery occlusion | Vascular disorders | — |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | — |
| Vascular access site dissection | General disorders | — |
| Pneumonia | Infections and infestations | — |
| Vessel perforation | Injury, poisoning and procedural complications | — |
| Acute left ventricular failure | Cardiac disorders | — |
| Cardiac failure congestive | Cardiac disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Ventricular fibrillation | Cardiac disorders | — |
| Procedural vomiting | Gastrointestinal disorders | — |
| Vascular stent occlusion | General disorders | — |
| Vascular access site pain | General disorders | — |
| Arterial perforation | General disorders | — |
| Vascular access site pseudoaneurysm | General disorders | — |
| Contrast media reaction | Immune system disorders | — |
| Gangrene | Infections and infestations | — |
| Respiratory tract infection | Infections and infestations | — |
| Abscess limb | Infections and infestations | — |
| Vascular access site haematoma | Injury, poisoning and procedural complications | — |
| Arterial bypass thrombosis | Injury, poisoning and procedural complications | — |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | — |
| Respiratory failure | Metabolism and nutrition disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Subclavian steal syndrome | Nervous system disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Reaction | System | Wingman Crossing Catheter |
|---|---|---|
| Vascular access site dissection | General disorders | — |
| Vascular access site haematoma | General disorders | — |
| Peripheral embolism | Vascular disorders | — |
Most-reported serious reactions: Peripheral artery occlusion, Vascular pseudoaneurysm, Vascular access site dissection, Pneumonia, Vessel perforation, Acute left ventricular failure, Cardiac failure congestive, Atrial fibrillation.
Data from ClinicalTrials.gov NCT03403426 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing