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CompletedNCT03403426Wing-ItUpdated Jan 7, 2021Results posted

ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

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

Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Total Occlusion of Artery of the Extremities
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Wingman Crossing Catheter

    Use of the device to support CTO crossing

    Device: Wingman Crossing Catheter

Interventions

  • DeviceWingman Crossing Catheter

    Endovascular CTO crossing

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Lesion Success

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

    Time frame: Intraprocedural

  2. 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

  3. 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

  4. Total Procedural Time

    Evaluation of total procedural time

    Time frame: Approximately 24 hours post procedure

  5. Device Procedural Time

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

    Time frame: Approximately 24 hours post procedure

  6. Contrast Use

    Evaluation of total procedural contrast volume use

    Time frame: Approximately 24 hours post procedure

  7. Fluoroscopic Time

    Evaluation of total procedural fluoroscopic time

    Time frame: Approximately 24 hours post procedure

06

Results

Posted Jan 7, 2021

Participant flow

Participant flow — Overall Study
MilestoneWingman Crossing Catheter
Started85
Completed82
Not completed3
Withdrew: Death1
Withdrew: Lost to follow-up2

Outcome measures

PrimaryNumber 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
Reported as:
Count of units · lesions
Number of Lesions With Successful CTO Crossing Assessed by Angiography
lesionsWingman Crossing Catheter
Number of Lesions With Successful CTO Crossing Assessed by Angiography77
PrimaryMajor 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
Reported as:
Count of participants · Participants
Major Adverse Event (MAE) Rate
ParticipantsWingman Crossing Catheter
Major Adverse Event (MAE) Rate4
PrimaryRate 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
Reported as:
Count of participants · Participants
Rate of Clinically Significant Perforations
ParticipantsWingman Crossing Catheter
Rate of Clinically Significant Perforations1
SecondaryLesion Success

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

Time frame:
Intraprocedural
Reported as:
Count of units · Lesions
Lesion Success
LesionsWingman Crossing Catheter
Lesion Success77
SecondaryProcedure 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
Reported as:
Count of participants · Participants
Procedure Success Rate
ParticipantsWingman Crossing Catheter
Procedure Success Rate75
SecondaryIncidence 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
Reported as:
Count of participants · Participants
Incidence of In-hospital AE or MAE
ParticipantsWingman Crossing Catheter
Incidence of In-hospital AE or MAE16
SecondaryTotal Procedural Time

Evaluation of total procedural time

Time frame:
Approximately 24 hours post procedure
Reported as:
Mean · minutes
Total Procedural Time
minutesWingman Crossing Catheter
Total Procedural Time102 ± 48
SecondaryDevice Procedural Time

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

Time frame:
Approximately 24 hours post procedure
Reported as:
Mean · minutes
Device Procedural Time
minutesWingman Crossing Catheter
Device Procedural Time12 ± 12
SecondaryContrast Use

Evaluation of total procedural contrast volume use

Time frame:
Approximately 24 hours post procedure
Reported as:
Mean · mL
Contrast Use
mLWingman Crossing Catheter
Contrast Use148 ± 79
SecondaryFluoroscopic Time

Evaluation of total procedural fluoroscopic time

Time frame:
Approximately 24 hours post procedure
Reported as:
Mean · minutes
Fluoroscopic Time
minutesWingman Crossing Catheter
Fluoroscopic Time30 ± 18

Adverse events

Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Wingman Crossing Catheter1/85 (1.2%)22/85 (25.9%)21/85 (24.7%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventWingman Crossing Catheter
Peripheral artery occlusionVascular disorders4/85
Vascular pseudoaneurysmInjury, poisoning and procedural complications3/85
Vascular access site dissectionGeneral disorders2/85
PneumoniaInfections and infestations2/85
Vessel perforationInjury, poisoning and procedural complications2/85
Acute left ventricular failureCardiac disorders1/85
Cardiac failure congestiveCardiac disorders1/85
Atrial fibrillationCardiac disorders1/85
Ventricular fibrillationCardiac disorders1/85
Procedural vomitingGastrointestinal disorders1/85
Most frequent other events
Most frequent other events
EventWingman Crossing Catheter
Vascular access site dissectionGeneral disorders10/85
Vascular access site haematomaGeneral disorders7/85
Peripheral embolismVascular disorders7/85

Baseline characteristics

Age, Continuous
Age, Continuous(years)Wingman Crossing Catheter
Mean71.4 ± 9.3
Sex: Female, Male
Sex: Female, Male(Participants)Wingman Crossing Catheter
Female29
Male56
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Wingman Crossing Catheter
Hispanic or Latino1
Not Hispanic or Latino84
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Wingman Crossing Catheter
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American5
White78
More than one race0
Unknown or Not Reported2
Region of Enrollment
Region of Enrollment(participants)Wingman Crossing Catheter
United States59
Austria15
Germany11
07

Study locations

1 site
  • Adventist St. Helena Hospital
    Saint Helena, California 94574, United States
08

References and documents

Study documents

  • Statistical analysis plan · May 20, 2019
  • Study protocol · Oct 3, 2018

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03403426
Lead sponsor
ReFlow Medical, Inc.
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Feb 13, 2018
Primary completion
Aug 8, 2019
Completion
Aug 8, 2019
Results posted
Jan 7, 2021
Last update
Jan 7, 2021

Study contacts

John Laird, MD
principal investigator · Adventist St. Helena Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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