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ReFlow Medical Wingman Catheter Wing-IT Clinical Trial (Wing-It)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03403426
Recruitment Status : Completed
First Posted : January 18, 2018
Results First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
ReFlow Medical, Inc.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 13, 2018
Actual Primary Completion Date : August 8, 2019
Actual Study Completion Date : August 8, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of Lesions With Successful CTO Crossing Assessed by Angiography [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Intraprocedural ]
    Lesion success, defined as attainment of <50% final residual stenosis of the target lesion using any percutaneous method

  2. Procedure Success Rate [ Time Frame: 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 [ Time Frame: Intraprocedural ]
    Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device

  4. Total Procedural Time [ Time Frame: Approximately 24 hours post procedure ]
    Evaluation of total procedural time

  5. Device Procedural Time [ Time Frame: Approximately 24 hours post procedure ]
    Evaluation of procedure time associated with use of the investigational device.

  6. Contrast Use [ Time Frame: Approximately 24 hours post procedure ]
    Evaluation of total procedural contrast volume use

  7. Fluoroscopic Time [ Time Frame: Approximately 24 hours post procedure ]
    Evaluation of total procedural fluoroscopic time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403426


Locations
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United States, California
Adventist St. Helena Hospital
Saint Helena, California, United States, 94574
Sponsors and Collaborators
ReFlow Medical, Inc.
Investigators
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Principal Investigator: John Laird, MD Adventist St. Helena Hospital
  Study Documents (Full-Text)

Documents provided by ReFlow Medical, Inc.:
Statistical Analysis Plan  [PDF] May 20, 2019
Study Protocol  [PDF] October 3, 2018

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Responsible Party: ReFlow Medical, Inc.
ClinicalTrials.gov Identifier: NCT03403426    
Other Study ID Numbers: RFM-CTO-13001
First Posted: January 18, 2018    Key Record Dates
Results First Posted: January 7, 2021
Last Update Posted: January 7, 2021
Last Verified: January 2021

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