Wing-It: ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

• Sponsor: ReFlow Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03403426
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.8
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Total Occlusion of Artery of the Extremities	Device: Wingman Crossing Catheter	N/A

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

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries
• Actual Study Start Date: Feb 13, 2018
• Actual Primary Completion Date: Aug 8, 2019
• Actual Study Completion Date: Aug 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wingman Crossing Catheter Use of the device to support CTO crossing	Device: Wingman Crossing Catheter; Endovascular CTO crossing

Outcome Measures

Primary Outcome Measures

1. Number of Lesions With Successful CTO Crossing Assessed by Angiography [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.

2. Major Adverse Event (MAE) Rate [Assessed from the time of the procedure through 30 days]

   Occurrence of significant in-hospital or 30-day MAEs.

3. Rate of Clinically Significant Perforations [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

Secondary Outcome Measures

1. Lesion Success [Intraprocedural]

   Lesion success, defined as attainment of <50% final residual stenosis of the target lesion using any percutaneous method

2. Procedure Success Rate [Approximately 24 hours post procedure]

   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

3. Incidence of In-hospital AE or MAE [Intraprocedural]

   Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device

4. Total Procedural Time [Approximately 24 hours post procedure]

   Evaluation of total procedural time

5. Device Procedural Time [Approximately 24 hours post procedure]

   Evaluation of procedure time associated with use of the investigational device.

6. Contrast Use [Approximately 24 hours post procedure]

   Evaluation of total procedural contrast volume use

7. Fluoroscopic Time [Approximately 24 hours post procedure]

   Evaluation of total procedural fluoroscopic time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adventist St. Helena Hospital	Saint Helena	California	United States	94574

Sponsors and Collaborators

• ReFlow Medical, Inc.

Investigators

• Principal Investigator: John Laird, MD, Adventist St. Helena Hospital

Study Documents (Full-Text)

• Statistical Analysis Plan - May 20, 2019
• Study Protocol - Oct 3, 2018

More Information

Publications

None provided.

• Responsible Party: ReFlow Medical, Inc.
• ClinicalTrials.gov Identifier: NCT03403426
• Other Study ID Numbers: RFM-CTO-13001
• First Posted: Jan 18, 2018
• Last Update Posted: Jan 7, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Period Title: Overall Study
STARTED	85
COMPLETED	82
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Overall Participants	85
Overall lesions	86
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.4 (9.3)
Sex: Female, Male (Count of Participants)
Female	29 34.1%
Male	56 65.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.2%
Not Hispanic or Latino	84 98.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 5.9%
White	78 91.8%
More than one race	0 0%
Unknown or Not Reported	2 2.4%
Region of Enrollment (participants) [Number]
United States	59 69.4%
Austria	15 17.6%
Germany	11 12.9%

Outcome Measures

1. Primary Outcome

Title	Number of Lesions With Successful CTO Crossing Assessed by Angiography
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	85
Measure lesions	86
Count of Units [lesions]	77

2. Primary Outcome

Title	Major Adverse Event (MAE) Rate
Description	Occurrence of significant in-hospital or 30-day MAEs.
Time Frame	Assessed from the time of the procedure through 30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	83
Count of Participants [Participants]	4 4.7%

3. Primary Outcome

Title	Rate of Clinically Significant Perforations
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	83
Count of Participants [Participants]	1 1.2%

4. Secondary Outcome

Title	Lesion Success
Description	Lesion success, defined as attainment of <50% final residual stenosis of the target lesion using any percutaneous method
Time Frame	Intraprocedural

Outcome Measure Data

Analysis Population Description

Denominator is not equal to 86 lesion due to missing data points in 3 patients.

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	85
Measure Lesions	83
Count of Units [Lesions]	77

5. Secondary Outcome

Title	Procedure Success Rate
Description	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

Outcome Measure Data

Analysis Population Description

Denominator is not to equal to 85 due to missing data points on 3 subjects.

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	82
Count of Participants [Participants]	75 88.2%

6. Secondary Outcome

Title	Incidence of In-hospital AE or MAE
Description	Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device
Time Frame	Intraprocedural

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	85
Count of Participants [Participants]	16 18.8%

7. Secondary Outcome

Title	Total Procedural Time
Description	Evaluation of total procedural time
Time Frame	Approximately 24 hours post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	85
Mean (Standard Deviation) [minutes]	102 (48)

8. Secondary Outcome

Title	Device Procedural Time
Description	Evaluation of procedure time associated with use of the investigational device.
Time Frame	Approximately 24 hours post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	85
Mean (Standard Deviation) [minutes]	12 (12)

9. Secondary Outcome

Title	Contrast Use
Description	Evaluation of total procedural contrast volume use
Time Frame	Approximately 24 hours post procedure

Outcome Measure Data

Analysis Population Description

Denominator is not to equal to 85 due to missing data on 4 patients.

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	81
Mean (Standard Deviation) [mL]	148 (79)

10. Secondary Outcome

Title	Fluoroscopic Time
Description	Evaluation of total procedural fluoroscopic time
Time Frame	Approximately 24 hours post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
Measure Participants	85
Mean (Standard Deviation) [minutes]	30 (18)

Adverse Events

Time Frame	30 days
Arm/Group Title	Wingman Crossing Catheter
Arm/Group Description	Use of the device to support CTO crossing Wingman Crossing Catheter: Endovascular CTO crossing
All Cause Mortality
	Wingman Crossing Catheter
	Affected / at Risk (%)	# Events
Total	1/85 (1.2%)
Serious Adverse Events
	Wingman Crossing Catheter
	Affected / at Risk (%)	# Events
Total	22/85 (25.9%)
Cardiac disorders
Acute left ventricular failure	1/85 (1.2%)
Cardiac failure congestive	1/85 (1.2%)
Atrial fibrillation	1/85 (1.2%)
Ventricular fibrillation	1/85 (1.2%)
Gastrointestinal disorders
Procedural vomiting	1/85 (1.2%)
General disorders
Vascular stent occlusion	1/85 (1.2%)
Vascular access site pain	1/85 (1.2%)
Vascular access site dissection	2/85 (2.4%)
Arterial perforation	1/85 (1.2%)
Vascular access site pseudoaneurysm	1/85 (1.2%)
Immune system disorders
Contrast media reaction	1/85 (1.2%)
Infections and infestations
Gangrene	1/85 (1.2%)
Respiratory tract infection	1/85 (1.2%)
Pneumonia	2/85 (2.4%)
Abscess limb	1/85 (1.2%)
Injury, poisoning and procedural complications
Vascular access site haematoma	1/85 (1.2%)
Vascular pseudoaneurysm	3/85 (3.5%)
Arterial bypass thrombosis	1/85 (1.2%)
Vessel perforation	2/85 (2.4%)
Post procedural haemorrhage	1/85 (1.2%)
Metabolism and nutrition disorders
Respiratory failure	1/85 (1.2%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/85 (1.2%)
Nervous system disorders
Subclavian steal syndrome	1/85 (1.2%)
Renal and urinary disorders
Acute kidney injury	1/85 (1.2%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/85 (1.2%)
Vascular disorders
Peripheral arterial occlusive disease	1/85 (1.2%)
Arteriovenous fistula	1/85 (1.2%)
Peripheral embolism	1/85 (1.2%)
Peripheral artery thrombosis	1/85 (1.2%)
Peripheral artery occlusion	4/85 (4.7%)
Intermittent claudication	1/85 (1.2%)
Other (Not Including Serious) Adverse Events
	Wingman Crossing Catheter
	Affected / at Risk (%)	# Events
Total	21/85 (24.7%)
General disorders
Vascular access site dissection	10/85 (11.8%)
Vascular access site haematoma	7/85 (8.2%)
Vascular disorders
Peripheral embolism	7/85 (8.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.