Clinical trial NCT03403426: ReFlow Medical Wingman Catheter Wing-IT Clinical Trial
Official title: A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Total Occlusion of Artery of the Extremities
Lead sponsor: ReFlow Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-18
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Lesions With Successful CTO Crossing Assessed by Angiography
timeFrame: Intraprocedural
measure: Major Adverse Event (MAE) Rate
timeFrame: Assessed from the time of the procedure through 30 days
measure: Rate of Clinically Significant Perforations
timeFrame: Will be assessed from the time of the procedure through 30 days
Secondary outcomes:
measure: Lesion Success
timeFrame: Intraprocedural
measure: Procedure Success Rate
timeFrame: Approximately 24 hours post procedure
measure: Incidence of In-hospital AE or MAE
timeFrame: Intraprocedural
measure: Total Procedural Time
timeFrame: Approximately 24 hours post procedure
measure: Device Procedural Time
timeFrame: Approximately 24 hours post procedure
measure: Contrast Use
timeFrame: Approximately 24 hours post procedure
measure: Fluoroscopic Time
timeFrame: Approximately 24 hours post procedure
Other outcomes:
Locations:
city: Saint Helena
country: United States
facility: Adventist St. Helena Hospital
state: California
Study officials:
affiliation: Adventist St. Helena Hospital
name: John Laird, MD
role: PRINCIPAL_INVESTIGATOR
References: