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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wingman Crossing Catheter | Experimental | Use of the device to support CTO crossing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wingman Crossing Catheter | Device | Endovascular CTO crossing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraprocedural |
| Major Adverse Event (MAE) Rate | Occurrence of significant in-hospital or 30-day MAEs. | 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 | Will be assessed from the time of the procedure through 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Success | Lesion success, defined as attainment of <50% final residual stenosis of the target lesion using any percutaneous method | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Laird, MD | Adventist St. Helena Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adventist St. Helena Hospital | St. Helena | California | 94574 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Wingman Crossing Catheter | Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Wingman Crossing Catheter | Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Units | lesions | Intraprocedural | lesions | lesions |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wingman Crossing Catheter | Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute left ventricular failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular access site dissection | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isa Rizk | Reflow Medical | 9494810399 | info@reflowmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2019 | Oct 3, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 3, 2018 | Oct 3, 2020 | Prot_001.pdf |
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| 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 | Intraprocedural |
| Total Procedural Time | Evaluation of total procedural time | Approximately 24 hours post procedure |
| Device Procedural Time | Evaluation of procedure time associated with use of the investigational device. | Approximately 24 hours post procedure |
| Contrast Use | Evaluation of total procedural contrast volume use | Approximately 24 hours post procedure |
| Fluoroscopic Time | Evaluation of total procedural fluoroscopic time | Approximately 24 hours post procedure |
| lesions |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
|
|
| lesions |
|
|
| Primary | Major Adverse Event (MAE) Rate | Occurrence of significant in-hospital or 30-day MAEs. | Denominator is not to equal to 85 due to incomplete 30-day follow-up data. 1 subject was lost to follow-up and 1 subject withdrew after 30 days but did not have a 30 day visit. All 85 patients were monitored for AEs in-hospital, but as the primary endpoint is through 30 days 2 of the patients were not included in the analysis after they withdrew or were lost to follow-up. Any adverse events were captured and reported in the adverse event module for all 85 patients. | Posted | Count of Participants | Participants | Assessed from the time of the procedure through 30 days |
|
|
|
| Primary | 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 | Denominator is not to equal to 85 due to incomplete 30-day follow-up data. 1 subject was lost to follow-up and 1 subject withdrew after 30 days but did not have a 30 day visit. | Posted | Count of Participants | Participants | Will be assessed from the time of the procedure through 30 days |
|
|
|
| Secondary | Lesion Success | Lesion success, defined as attainment of <50% final residual stenosis of the target lesion using any percutaneous method | Denominator is not equal to 86 lesion due to missing data points in 3 patients. | Posted | Count of Units | Lesions | Intraprocedural | Lesions | Lesions |
|
|
|
| Secondary | 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 | Denominator is not to equal to 85 due to missing data points on 3 subjects. | Posted | Count of Participants | Participants | Approximately 24 hours post procedure |
|
|
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| Secondary | Incidence of In-hospital AE or MAE | Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device | Posted | Count of Participants | Participants | Intraprocedural |
|
|
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| Secondary | Total Procedural Time | Evaluation of total procedural time | Posted | Mean | Standard Deviation | minutes | Approximately 24 hours post procedure |
|
|
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| Secondary | Device Procedural Time | Evaluation of procedure time associated with use of the investigational device. | Posted | Mean | Standard Deviation | minutes | Approximately 24 hours post procedure |
|
|
|
| Secondary | Contrast Use | Evaluation of total procedural contrast volume use | Denominator is not to equal to 85 due to missing data on 4 patients. | Posted | Mean | Standard Deviation | mL | Approximately 24 hours post procedure |
|
|
|
| Secondary | Fluoroscopic Time | Evaluation of total procedural fluoroscopic time | Posted | Mean | Standard Deviation | minutes | Approximately 24 hours post procedure |
|
|
|
| 1 |
| 85 |
| 22 |
| 85 |
| 21 |
| 85 |
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
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| Procedural vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Vascular stent occlusion | General disorders | Systematic Assessment |
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| Vascular access site pain | General disorders | Systematic Assessment |
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| Vascular access site dissection | General disorders | Systematic Assessment |
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| Arterial perforation | General disorders | Systematic Assessment |
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| Vascular access site pseudoaneurysm | General disorders | Systematic Assessment |
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| Contrast media reaction | Immune system disorders | Systematic Assessment |
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| Gangrene | Infections and infestations | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Abscess limb | Infections and infestations | Systematic Assessment |
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| Vascular access site haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
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| Arterial bypass thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vessel perforation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Respiratory failure | Metabolism and nutrition disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Subclavian steal syndrome | Nervous system disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | Systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | Systematic Assessment |
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| Peripheral embolism | Vascular disorders | Systematic Assessment |
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| Peripheral artery thrombosis | Vascular disorders | Systematic Assessment |
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| Peripheral artery occlusion | Vascular disorders | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | Systematic Assessment |
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| Vascular access site haematoma | General disorders | Non-systematic Assessment |
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| Peripheral embolism | Vascular disorders | Non-systematic Assessment |
|
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