Trial Outcomes & Findings for ReFlow Medical Wingman Catheter Wing-IT Clinical Trial (NCT NCT03403426)
NCT ID: NCT03403426
Last Updated: 2021-01-07
Results Overview
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.
COMPLETED
NA
85 participants
Intraprocedural
2021-01-07
Participant Flow
Participant milestones
| Measure |
Wingman Crossing Catheter
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Overall Study
STARTED
|
85
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Wingman Crossing Catheter
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
ReFlow Medical Wingman Catheter Wing-IT Clinical Trial
Baseline characteristics by cohort
| Measure |
Wingman Crossing Catheter
n=86 lesions
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=99 Participants
|
|
Region of Enrollment
Austria
|
15 participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: IntraproceduralWhile 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.
Outcome measures
| Measure |
Wingman Crossing Catheter
n=86 lesions
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Number of Lesions With Successful CTO Crossing Assessed by Angiography
|
77 lesions
|
PRIMARY outcome
Timeframe: Assessed from the time of the procedure through 30 daysPopulation: 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.
Occurrence of significant in-hospital or 30-day MAEs.
Outcome measures
| Measure |
Wingman Crossing Catheter
n=83 Participants
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Major Adverse Event (MAE) Rate
|
4 Participants
|
PRIMARY outcome
Timeframe: Will be assessed from the time of the procedure through 30 daysPopulation: 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.
Occurrence of clinically significant perforation, after Wingman CTO crossing and PTA of lesion, confirmed by angiography, evaluated by angiographic core lab
Outcome measures
| Measure |
Wingman Crossing Catheter
n=83 Participants
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Rate of Clinically Significant Perforations
|
1 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralPopulation: Denominator is not equal to 86 lesion due to missing data points in 3 patients.
Lesion success, defined as attainment of \<50% final residual stenosis of the target lesion using any percutaneous method
Outcome measures
| Measure |
Wingman Crossing Catheter
n=83 Lesions
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Lesion Success
|
77 Lesions
|
SECONDARY outcome
Timeframe: Approximately 24 hours post procedurePopulation: Denominator is not to equal to 85 due to missing data points on 3 subjects.
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
Outcome measures
| Measure |
Wingman Crossing Catheter
n=82 Participants
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Procedure Success Rate
|
75 Participants
|
SECONDARY outcome
Timeframe: IntraproceduralProcedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device
Outcome measures
| Measure |
Wingman Crossing Catheter
n=85 Participants
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Incidence of In-hospital AE or MAE
|
16 Participants
|
SECONDARY outcome
Timeframe: Approximately 24 hours post procedureEvaluation of total procedural time
Outcome measures
| Measure |
Wingman Crossing Catheter
n=85 Participants
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Total Procedural Time
|
102 minutes
Standard Deviation 48
|
SECONDARY outcome
Timeframe: Approximately 24 hours post procedureEvaluation of procedure time associated with use of the investigational device.
Outcome measures
| Measure |
Wingman Crossing Catheter
n=85 Participants
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Device Procedural Time
|
12 minutes
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Approximately 24 hours post procedurePopulation: Denominator is not to equal to 85 due to missing data on 4 patients.
Evaluation of total procedural contrast volume use
Outcome measures
| Measure |
Wingman Crossing Catheter
n=81 Participants
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Contrast Use
|
148 mL
Standard Deviation 79
|
SECONDARY outcome
Timeframe: Approximately 24 hours post procedureEvaluation of total procedural fluoroscopic time
Outcome measures
| Measure |
Wingman Crossing Catheter
n=85 Participants
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Fluoroscopic Time
|
30 minutes
Standard Deviation 18
|
Adverse Events
Wingman Crossing Catheter
Serious adverse events
| Measure |
Wingman Crossing Catheter
n=85 participants at risk
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
Cardiac disorders
Acute left ventricular failure
|
1.2%
1/85 • 30 days
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
1/85 • 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/85 • 30 days
|
|
Cardiac disorders
Ventricular fibrillation
|
1.2%
1/85 • 30 days
|
|
Gastrointestinal disorders
Procedural vomiting
|
1.2%
1/85 • 30 days
|
|
General disorders
Vascular stent occlusion
|
1.2%
1/85 • 30 days
|
|
General disorders
Vascular access site pain
|
1.2%
1/85 • 30 days
|
|
General disorders
Vascular access site dissection
|
2.4%
2/85 • 30 days
|
|
General disorders
Arterial perforation
|
1.2%
1/85 • 30 days
|
|
General disorders
Vascular access site pseudoaneurysm
|
1.2%
1/85 • 30 days
|
|
Immune system disorders
Contrast media reaction
|
1.2%
1/85 • 30 days
|
|
Infections and infestations
Gangrene
|
1.2%
1/85 • 30 days
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/85 • 30 days
|
|
Infections and infestations
Pneumonia
|
2.4%
2/85 • 30 days
|
|
Infections and infestations
Abscess limb
|
1.2%
1/85 • 30 days
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
1.2%
1/85 • 30 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
3.5%
3/85 • 30 days
|
|
Injury, poisoning and procedural complications
Arterial bypass thrombosis
|
1.2%
1/85 • 30 days
|
|
Injury, poisoning and procedural complications
Vessel perforation
|
2.4%
2/85 • 30 days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.2%
1/85 • 30 days
|
|
Metabolism and nutrition disorders
Respiratory failure
|
1.2%
1/85 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/85 • 30 days
|
|
Nervous system disorders
Subclavian steal syndrome
|
1.2%
1/85 • 30 days
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/85 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/85 • 30 days
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.2%
1/85 • 30 days
|
|
Vascular disorders
Arteriovenous fistula
|
1.2%
1/85 • 30 days
|
|
Vascular disorders
Peripheral embolism
|
1.2%
1/85 • 30 days
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.2%
1/85 • 30 days
|
|
Vascular disorders
Peripheral artery occlusion
|
4.7%
4/85 • 30 days
|
|
Vascular disorders
Intermittent claudication
|
1.2%
1/85 • 30 days
|
Other adverse events
| Measure |
Wingman Crossing Catheter
n=85 participants at risk
Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing
|
|---|---|
|
General disorders
Vascular access site dissection
|
11.8%
10/85 • 30 days
|
|
General disorders
Vascular access site haematoma
|
8.2%
7/85 • 30 days
|
|
Vascular disorders
Peripheral embolism
|
8.2%
7/85 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place