Trial Outcomes & Findings for Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization (NCT NCT02961894)
NCT ID: NCT02961894
Last Updated: 2020-11-02
Results Overview
Freedom from Major Adverse Events is defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair, and clinically-significant distal embolization in the target limb; as adjudicated by an independent Clinical Events Committee The primary safety endpoint is freedom from 30-day Major Adverse Events (MAE), defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair and clinically-significant distal embolization in the target limb; as adjudicated by the independent Clinical Events Committee (CEC).
COMPLETED
NA
121 participants
30-Day
2020-11-02
Participant Flow
Participant milestones
| Measure |
Revolution Treatment Arm
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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|---|---|
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Overall Study
STARTED
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121
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Overall Study
COMPLETED
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121
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
Baseline characteristics by cohort
| Measure |
Revolution Treatment Arm
n=121 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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|---|---|
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Age, Customized
Age
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72 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
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Sex: Female, Male
Female
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50 Participants
n=5 Participants
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Sex: Female, Male
Male
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71 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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28 Participants
n=5 Participants
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Race (NIH/OMB)
White
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90 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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3 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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121 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 30-DayFreedom from Major Adverse Events is defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair, and clinically-significant distal embolization in the target limb; as adjudicated by an independent Clinical Events Committee The primary safety endpoint is freedom from 30-day Major Adverse Events (MAE), defined as the composite of all-cause mortality, clinically-driven target lesion revascularization (TLR), major target limb amputation, major target vessel perforation requiring surgical or endovascular repair and clinically-significant distal embolization in the target limb; as adjudicated by the independent Clinical Events Committee (CEC).
Outcome measures
| Measure |
Revolution Treatment Arm
n=113 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Safety Endpoint: Number of Participants With Freedom From Major Adverse Events
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110 Participants
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PRIMARY outcome
Timeframe: 1-DayTechnical success is defined by ≤50% diameter stenosis after atherectomy with the Revolution™ Peripheral Atherectomy System and prior to adjunctive therapy, as measured by the independent core laboratory on the post-atherectomy contrast angiogram. Effectiveness will be assessed for investigator-identified target lesions and will be calculated as a binary variable as the percentage of target lesions with technical success.
Outcome measures
| Measure |
Revolution Treatment Arm
n=123 Lesions
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Effectiveness Endpoint: Technical Success
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111 Lesions
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SECONDARY outcome
Timeframe: 30 DaysTarget Lesion Revascularization (TLR) rate through 30 days.
Outcome measures
| Measure |
Revolution Treatment Arm
n=121 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Target Lesion Revascularization (TLR) Rate
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0 Participants
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SECONDARY outcome
Timeframe: 1-DayChange in % stenosis after treatment with Revolution™ Peripheral Atherectomy System, determined after atherectomy and prior to other adjunctive therapies, as measured by the angiographic core laboratory.
Outcome measures
| Measure |
Revolution Treatment Arm
n=123 Lesions
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Change in % Stenosis
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31.8 Percentage
Standard Deviation 19
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SECONDARY outcome
Timeframe: 1-DayPopulation: 132 total lesions in the Per Protocol dataset. Images missing for 2 lesions; calibration missing for 3 lesions therefore only 127 post procedure angiograms available.
Procedural success as defined by target lesion residual stenosis of \<30% at the conclusion of the index procedure, after atherectomy and any adjunctive endovascular treatment, as measured by the angiographic core laboratory.
Outcome measures
| Measure |
Revolution Treatment Arm
n=127 Lesions
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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|---|---|
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Procedural Success
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119 Lesions
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SECONDARY outcome
Timeframe: 6 monthsAssessment of the total combined components of the primary safety endpoint (Freedom from MAE); including all-cause mortality, major target limb amputation, clinically significant distal embolization, major target vessel perforation requiring surgical or endovascular repair, and clinically-driven TLR, measured through 6 months.
Outcome measures
| Measure |
Revolution Treatment Arm
n=121 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Assessment of the Combined Components of the Primary Safety Endpoint, Freedom From MAE
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97 Participants
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SECONDARY outcome
Timeframe: 6 monthsFreedom from Target Lesion Revascularization (TLR) rate through 6 months.
Outcome measures
| Measure |
Revolution Treatment Arm
n=121 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Freedom From Target Lesion Revascularization (TLR) Rate
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105 Participants
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SECONDARY outcome
Timeframe: 30 DaysFreedom from Myocardial infarction through 30 days.
Outcome measures
| Measure |
Revolution Treatment Arm
n=121 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Freedom From Myocardial Infarction
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121 Participants
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SECONDARY outcome
Timeframe: 6 monthsFreedom from Myocardial infarction through 6 months.
Outcome measures
| Measure |
Revolution Treatment Arm
n=121 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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|---|---|
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Freedom From Myocardial Infarction
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119 Participants
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SECONDARY outcome
Timeframe: 30 DaysFreedom from incidence of target vessel revascularization (TVR) through 30 days.
Outcome measures
| Measure |
Revolution Treatment Arm
n=121 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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|---|---|
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Freedom From Target Vessel Revascularization (TVR) Rate
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121 Participants
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SECONDARY outcome
Timeframe: 6 monthsFreedom from incidence of target vessel revascularization (TVR) through 6 months.
Outcome measures
| Measure |
Revolution Treatment Arm
n=121 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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|---|---|
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Freedom From Target Vessel Revascularization (TVR) Rate
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121 Participants
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SECONDARY outcome
Timeframe: 1-DayFreedom from angiographic procedural distal embolization (symptomatic) in the target limb as confirmed angiographically by the core laboratory.
Outcome measures
| Measure |
Revolution Treatment Arm
n=121 Participants
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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|---|---|
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Freedom From Angiographic Procedural Distal Embolization
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119 Participants
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SECONDARY outcome
Timeframe: 30 Days, 6 monthsPopulation: Among the 132 lesions in the Per Protocol dataset, four were excluded from the patency analyses due to missing post-atherectomy angiograms, leaving 128 lesions in the analysis.
Primary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.
Outcome measures
| Measure |
Revolution Treatment Arm
n=128 Lesions
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Primary Patency
30 Days
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99.1 Percentage of primary patency
Standard Error 0.9
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Primary Patency
6 Months
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81.6 Percentage of primary patency
Standard Error 4.0
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SECONDARY outcome
Timeframe: 30 Days, 6 monthsPopulation: Among the 132 lesions in the Per Protocol dataset, four were excluded from the patency analyses due to missing post-atherectomy angiograms, leaving 128 lesions in the analysis.
Primary-assisted patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.
Outcome measures
| Measure |
Revolution Treatment Arm
n=128 Number of Per protocol lesions
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Assisted Primary Patency
30 Days
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99.1 Percentage of assisted primary patency
Standard Error 0.9
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Assisted Primary Patency
6 Months
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87.7 Percentage of assisted primary patency
Standard Error 3.4
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SECONDARY outcome
Timeframe: 30 Days, 6 monthsPopulation: Among the 132 lesions in the Per Protocol dataset, four were excluded from the patency analyses due to missing post-atherectomy angiograms, leaving 128 lesions in the analysis.
Secondary patency of the target lesion at 30 days and 6 months, determined by duplex ultrasound or angiography.
Outcome measures
| Measure |
Revolution Treatment Arm
n=128 Number of Per protocol lesions
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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|---|---|
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Secondary Patency
30 Days
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99.1 Percentage of secondary patency
Standard Error 0.9
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Secondary Patency
6 Months
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91.6 Percentage of secondary patency
Standard Error 2.9
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Adverse Events
Revolution Treatment Arm
Serious adverse events
| Measure |
Revolution Treatment Arm
n=121 participants at risk
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Vascular disorders
Clinically Driven TLR
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13.2%
16/121 • 6 months
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Surgical and medical procedures
Major target limb amputation
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1.7%
2/121 • 6 months
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Vascular disorders
Perforation of target vessel
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3.3%
4/121 • 6 months
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Vascular disorders
Distal embolization
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0.83%
1/121 • 6 months
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General disorders
All-cause mortality
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2.5%
3/121 • 6 months
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Other adverse events
| Measure |
Revolution Treatment Arm
n=121 participants at risk
This is a single-arm study. All eligible and participating patients will be treated wit the Revolution™ Peripheral Atherectomy System.
Revolution™ Peripheral Atherectomy System: The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
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Blood and lymphatic system disorders
Blood and lymphatic system disorders
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12.4%
15/121 • 6 months
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Cardiac disorders
Cardiac disorders
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13.2%
16/121 • 6 months
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Endocrine disorders
Endocrine disorders
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1.7%
2/121 • 6 months
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Eye disorders
Eye disorders
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2.5%
3/121 • 6 months
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Gastrointestinal disorders
Gastrointestinal disorders
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7.4%
9/121 • 6 months
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General disorders
General disorders and administration site conditions
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19.0%
23/121 • 6 months
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Hepatobiliary disorders
Hepatobiliary disorders
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0.83%
1/121 • 6 months
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Infections and infestations
Infections and infestations
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13.2%
16/121 • 6 months
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Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
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11.6%
14/121 • 6 months
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Investigations
Investigations
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1.7%
2/121 • 6 months
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Metabolism and nutrition disorders
Metabolism and nutrition disorders
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2.5%
3/121 • 6 months
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Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
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6.6%
8/121 • 6 months
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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0.83%
1/121 • 6 months
|
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Nervous system disorders
Nervous system disorders
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3.3%
4/121 • 6 months
|
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Product Issues
Product issues
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0.83%
1/121 • 6 months
|
|
Psychiatric disorders
Psychiatric disorders
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0.83%
1/121 • 6 months
|
|
Renal and urinary disorders
Renal and urinary disorders
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4.1%
5/121 • 6 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
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0.83%
1/121 • 6 months
|
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Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
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3.3%
4/121 • 6 months
|
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Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
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3.3%
4/121 • 6 months
|
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Surgical and medical procedures
Surgical and medical procedures
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1.7%
2/121 • 6 months
|
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Vascular disorders
Vascular disorders
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30.6%
37/121 • 6 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place