Chronic Total Occlusion of Artery of the Extremities
Conditions
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.
Interventions
DEVICEWingman Crossing Catheter
Endovascular CTO crossing
Sponsors
ReFlow Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Major Adverse Event (MAE) Rate | Assessed from the time of the procedure through 30 days | Occurrence of significant in-hospital or 30-day MAEs. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total Procedural Time | Approximately 24 hours post procedure | Evaluation of total procedural time |
| Device Procedural Time | Approximately 24 hours post procedure | Evaluation of procedure time associated with use of the investigational device. |
| Lesion Success | Intraprocedural | Lesion success, defined as attainment of \<50% final residual stenosis of the target lesion using any percutaneous method |
| Fluoroscopic Time | Approximately 24 hours post procedure | Evaluation of total procedural fluoroscopic time |
| Contrast Use | Approximately 24 hours post procedure | Evaluation of total procedural contrast volume use |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wingman Crossing Catheter Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing | 85 |
| Wingman Crossing Catheter Use of the device to support CTO crossing
Wingman Crossing Catheter: Endovascular CTO crossing | 86 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Wingman Crossing Catheter |
|---|---|
| Age, Continuous | 71.4 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Region of Enrollment Austria | 15 participants |
| Region of Enrollment Germany | 11 participants |
| Region of Enrollment United States | 59 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 85 |
| other Total, other adverse events | 21 / 85 |
| serious Total, serious adverse events | 22 / 85 |
Outcome results
Primary
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wingman Crossing Catheter | Major Adverse Event (MAE) Rate | 4 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Wingman Crossing Catheter | Number of Lesions With Successful CTO Crossing Assessed by Angiography | 77 lesions |
Primary
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wingman Crossing Catheter | Rate of Clinically Significant Perforations | 1 Participants |
Secondary
Contrast Use
Evaluation of total procedural contrast volume use
Time frame: Approximately 24 hours post procedure
Population: Denominator is not to equal to 85 due to missing data on 4 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wingman Crossing Catheter | Contrast Use | 148 mL | Standard Deviation 79 |
Secondary
Device Procedural Time
Evaluation of procedure time associated with use of the investigational device.
Time frame: Approximately 24 hours post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wingman Crossing Catheter | Device Procedural Time | 12 minutes | Standard Deviation 12 |
Secondary
Fluoroscopic Time
Evaluation of total procedural fluoroscopic time
Time frame: Approximately 24 hours post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wingman Crossing Catheter | Fluoroscopic Time | 30 minutes | Standard Deviation 18 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wingman Crossing Catheter | Incidence of In-hospital AE or MAE | 16 Participants |
Secondary
Lesion Success
Lesion success, defined as attainment of \<50% final residual stenosis of the target lesion using any percutaneous method
Time frame: Intraprocedural
Population: Denominator is not equal to 86 lesion due to missing data points in 3 patients.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Wingman Crossing Catheter | Lesion Success | 77 Lesions |
Secondary
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
Population: Denominator is not to equal to 85 due to missing data points on 3 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wingman Crossing Catheter | Procedure Success Rate | 75 Participants |
Secondary
Total Procedural Time
Evaluation of total procedural time
Time frame: Approximately 24 hours post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wingman Crossing Catheter | Total Procedural Time | 102 minutes | Standard Deviation 48 |