Trial Outcomes & Findings for AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study) (NCT NCT04663867)
NCT ID: NCT04663867
Last Updated: 2026-02-12
Results Overview
Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.
COMPLETED
NA
79 participants
24 Hours
2026-02-12
Participant Flow
The study enrolled a total of 79 participants, with only 74 participants analyzed for effectiveness Outcome Measures. Study results (Outcome Measures) are reported for the 74 participants in the "Full Analysis Set (FAS)" Group described below. The 5 excluded participants are described in in other study Groups, excluded from effectiveness analyses, but included in the safety analyses (Adverse Event reporting).
Participant milestones
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version. These study participants are also included in the safety analysis of all (n=79) study participants.
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Excluded Participants: Earlier Iteration of the Investigational Device
N=4 study participants were excluded from the effectiveness analysis because they were enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the investigational device, whose use was discontinued early on in the study. These study participants are included in the safety analysis of all (n=79) study participants.
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Excluded Participant: Roll-In Subject
N=1 study participant was excluded from the effectiveness analysis because they were enrolled as a "roll-in" subject under a prior version of the Study Protocol. This study participant is included in the safety analysis of all (n=79) study participants.
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|---|---|---|---|
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Overall Study
STARTED
|
74
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4
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1
|
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Overall Study
COMPLETED
|
74
|
4
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1
|
|
Overall Study
NOT COMPLETED
|
0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Twelve (12) participants had Secondary Arterial Access.
Baseline characteristics by cohort
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=74 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Age, Continuous
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69.4 years
STANDARD_DEVIATION 9.02 • n=74 Participants
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Sex: Female, Male
Female
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26 Participants
n=74 Participants
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Sex: Female, Male
Male
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48 Participants
n=74 Participants
|
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Race/Ethnicity, Customized
Black, non-Hispanic
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8 Participants
n=74 Participants
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|
Race/Ethnicity, Customized
Hispanic
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3 Participants
n=74 Participants
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Race/Ethnicity, Customized
Other, non-Hispanic
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1 Participants
n=74 Participants
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Race/Ethnicity, Customized
White, non-Hispanic
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61 Participants
n=74 Participants
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Race/Ethnicity, Customized
Missing
|
1 Participants
n=74 Participants
|
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Region of Enrollment
United States
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74 participants
n=74 Participants
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Arterial Access Type
Primary Access · Retrograde Femoral
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62 Participants
n=74 Participants • Twelve (12) participants had Secondary Arterial Access.
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Arterial Access Type
Primary Access · Antegrade Femoral
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12 Participants
n=74 Participants • Twelve (12) participants had Secondary Arterial Access.
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Arterial Access Type
Primary Access · Pedal
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0 Participants
n=74 Participants • Twelve (12) participants had Secondary Arterial Access.
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Arterial Access Type
Primary Access · Popliteal
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0 Participants
n=74 Participants • Twelve (12) participants had Secondary Arterial Access.
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Arterial Access Type
Secondary Access · Retrograde Femoral
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1 Participants
n=12 Participants • Twelve (12) participants had Secondary Arterial Access.
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Arterial Access Type
Secondary Access · Antegrade Femoral
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2 Participants
n=12 Participants • Twelve (12) participants had Secondary Arterial Access.
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|
Arterial Access Type
Secondary Access · Pedal
|
9 Participants
n=12 Participants • Twelve (12) participants had Secondary Arterial Access.
|
|
Arterial Access Type
Secondary Access · Popliteal
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0 Participants
n=12 Participants • Twelve (12) participants had Secondary Arterial Access.
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PRIMARY outcome
Timeframe: 24 HoursPopulation: The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=74 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Clinical Success of AngioSafe Peripheral CTO Crossing System
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65 Participants
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SECONDARY outcome
Timeframe: Procedure, evaluated directly after performing the investigational procedurePopulation: The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
Technical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=74 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Technical Success of AngioSafe Peripheral CTO Crossing System
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65 Participants
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SECONDARY outcome
Timeframe: 30 DaysPopulation: The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
Procedural Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen without a procedural complication within 30 days after the procedure. Procedural complication is defined as the need for open or repeat endovascular surgical repair in the treated limb, or a major bleeding event.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=74 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Procedural Success of AngioSafe Peripheral CTO Crossing System
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65 Participants
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SECONDARY outcome
Timeframe: Procedure, evaluated directly after performing the investigational procedurePopulation: Post-procedure IVUS evaluations were available for only 55 study participants from the Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
Post-procedure IVUS evaluation of Technical Success cases to determine if crossing was performed intraluminally.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=55 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).
Total Intraluminal
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44 Participants
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Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).
Partial Intraluminal with ≥50% of IVUS image frames Intraplaque
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7 Participants
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Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).
Partial Intraluminal with <50% of IVUS image frames Intraplaque or Extraluminal
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3 Participants
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Evaluation of Intraluminal CTO Crossing Facilitated by the Peripheral CTO Crossing System, as Assessed by an Intravascular Ultrasound (IVUS).
Not Evaluable
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1 Participants
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SECONDARY outcome
Timeframe: 24-hoursPopulation: The Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version included 53 subjects with Moderate to Severe Calcification and 21 subjects with None to Mild Calcification
Clinical Success is defined as the ability of the catheter to facilitate placement of a guidewire into the distal lumen in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner, analyzed by degree of calcification in two subgroups: None/Focal/Mild calcification, or Moderate/Severe calcification.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=74 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).
Moderate to Severe Calcification · Clinical Success
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46 Participants
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The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).
Moderate to Severe Calcification · Failure
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7 Participants
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The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).
None to Mild Calcification · Clinical Success
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19 Participants
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The Primary Endpoint (Clinical Success) in the Subgroups by the Degree of Calcification (None/Focal/Mild, and Moderate/Severe).
None to Mild Calcification · Failure
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2 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: Procedure, evaluated during the investigational procedurePopulation: Lesion crossing time was available for only 64 study participants from the Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=64 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Lesion Crossing Time, Mean
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25 min
Standard Error 4
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OTHER_PRE_SPECIFIED outcome
Timeframe: Procedure, evaluated during the investigational procedurePopulation: Lesion crossing time was available for only 64 study participants from the Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
Lesion crossing time is defined as time starting from the placement of the Peripheral CTO Crossing System at the proximal cap to the time the guidewire is placed in the distal true vessel lumen.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=64 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Lesion Crossing Time, Median
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9 min
Interval 6.0 to 16.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 30-daysPopulation: The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
The mean change in the Rutherford Clinical Classification (RCC) assessment at 30 days versus baseline. The Rutherford Clinical Classification (RCC) Scale identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. The RCC Scale Categories and associated Clinical Descriptions are as follows: 0 - Asymptomatic, 1 - Mild claudication, 2- Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=74 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Rutherford Clinical Classification (RCC) Assessment
Mean change in RCC Score
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-2.14 RCC Scores on a scale
Standard Error 0.17
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|
Rutherford Clinical Classification (RCC) Assessment
Mean RCC Score at Baseline
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3.40 RCC Scores on a scale
Standard Error 0.09
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Rutherford Clinical Classification (RCC) Assessment
Mean RCC Score at 30-Days
|
1.25 RCC Scores on a scale
Standard Error 0.20
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POST_HOC outcome
Timeframe: Procedure, evaluated directly after performing the investigational procedurePopulation: The Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version included n=55 participants with Technical Success (Outcome Measure 2), with angiographic imaging available for n=43 study participants.
Angiographic images were post-processed and analyzed to demonstrate angiographic visibility of intraplaque channel formation and to quantify the track width.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=43 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Post-CTO-Crossing Track Dimensions: Width
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2.87 mm
Standard Deviation 0.74
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POST_HOC outcome
Timeframe: Procedure, evaluated directly after performing the investigational procedurePopulation: The Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version included n=55 participants with Technical Success (Outcome Measure 2), with IVUS imaging available for n=44 study participants.
Intravascular Ultrasounds (IVUS) images were post-processed and analyzed to demonstrate IVUS-confirmation of intraplaque channel formation and to quantify the track diameter.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=44 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Post-CTO-Crossing Track Dimensions: Diameter
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2.78 mm
Standard Deviation 0.73
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POST_HOC outcome
Timeframe: Procedure, evaluated directly after performing the investigational procedurePopulation: The Full Analysis Set (FAS) (n=74) of all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version included n=55 participants with Technical Success (Outcome Measure 2), with IVUS imaging available for n=44 study participants.
Intravascular Ultrasounds (IVUS) images were post-processed and analyzed to demonstrate IVUS-confirmation of intraplaque channel formation, and to quantify the track dimensions.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=44 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
|
|---|---|
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Post-CTO-Crossing Track Dimensions: Cross Sectional Area
|
6.71 mm^2
Standard Deviation 3.7
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 30-daysPopulation: The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
The mean change in Pain Numeric Rating Scale (NRS) assessment at 30-days versus baseline. The Pain Numeric Rating Scale (Pain NRS) is a unidimensional measure of pain intensity in adults. The NRS is anchored by terms describing pain severity extremes, where 0 represents no pain and 10 represents the worst pain possible. The NRS Ratings and associated Clinical Descriptions are as follows: 0 - No Pain, 1-3 - Mild Pain, 4-6 - Moderate Pain, 7-9 - Severe Pain, 10 - Worst Pain Possible.
Outcome measures
| Measure |
Full Analysis Set (FAS), All Study Participants With Reported Outcome Measures
n=74 Participants
The Full Analysis Set (FAS) (n=74) includes all study participants analyzed for effectiveness with reported Outcome Measures under the final Study Protocol version.
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|---|---|
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Pain Numeric Rating Scale (NRS) Assessment
Mean change in Pain NRS Rating
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-3.17 Pain NRS Scores on a scale
Standard Error 0.39
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Pain Numeric Rating Scale (NRS) Assessment
Mean Pain NRS Rating at Baseline
|
5.24 Pain NRS Scores on a scale
Standard Error 0.36
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|
Pain Numeric Rating Scale (NRS) Assessment
Mean Pain NRS Rating at 30-days
|
2.06 Pain NRS Scores on a scale
Standard Error 0.33
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Adverse Events
All Study Participants
Serious adverse events
| Measure |
All Study Participants
n=79 participants at risk
All study participants (n=79), including: n=74 participants treated the investigational device under the final Study Protocol version, n=4 participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the investigational device, and n=1 participant enrolled as a "roll-in" subject under a prior version of the Study Protocol, are included in safety analysis of Adverse Events.
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|---|---|
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Surgical and medical procedures
Ansel sheath complication
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1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Blood and lymphatic system disorders
Anemia
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1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Surgical and medical procedures
Balloon failure
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1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
General disorders
Death
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Cardiac disorders
Hypertension
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Infections and infestations
Infection
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
General disorders
Pain
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Surgical and medical procedures
Pseudoaneurysm
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
Other adverse events
| Measure |
All Study Participants
n=79 participants at risk
All study participants (n=79), including: n=74 participants treated the investigational device under the final Study Protocol version, n=4 participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the investigational device, and n=1 participant enrolled as a "roll-in" subject under a prior version of the Study Protocol, are included in safety analysis of Adverse Events.
|
|---|---|
|
General disorders
Acute digital ischemia
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Vascular disorders
Arterial blush
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Surgical and medical procedures
Arterial dissection
|
15.2%
12/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Surgical and medical procedures
Arterial perforation
|
5.1%
4/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Vascular disorders
Arteriovenous fistula
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Cardiac disorders
Bradycardia
|
2.5%
2/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
General disorders
Rutherford Declines
|
2.5%
2/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
General disorders
Edema
|
8.9%
7/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
General disorders
Hematoma
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Blood and lymphatic system disorders
Hematuria
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Cardiac disorders
Hypertension
|
2.5%
2/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Cardiac disorders
Hypotension
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Infections and infestations
Infection
|
2.5%
2/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Psychiatric disorders
Major depression
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
General disorders
Nausea
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
General disorders
Pain
|
10.1%
8/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Cardiac disorders
Tachycardia
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
|
Vascular disorders
Total occlusion
|
1.3%
1/79 • 30-days
AEs are reported for all study participants (n=79) including the primary analysis population (Full Analysis Set (FAS, n=74), participants enrolled under a prior version of the Study Protocol and treated with an earlier iteration of the device (n=4), and a participant enrolled as a "roll-in" subject under a prior version of the Study Protocol (n=1). Combined AE reporting for all 79 study participants was pre-specified in the study Statistical Analysis Plan (SAP).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place