Trial Outcomes & Findings for Evaluation of the Pantheris Atherectomy System (NCT NCT01937351)
NCT ID: NCT01937351
Last Updated: 2021-03-25
Results Overview
The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include: 1. Cardiovascular related death 2. Unplanned, major index limb amputation 3. Clinically driven target lesion revascularization (TLR) 4. Myocardial infarction 5. Device related events: 1. Clinically significant perforation 2. Clinically significant dissection 3. Clinically significant embolus 4. Pseudoaneurysm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
Day 0 through 6 Months
Results posted on
2021-03-25
Participant Flow
Participant milestones
| Measure |
Primary Cohort
The Primary Cohort consisted of either the 1st subject enrolled after the Roll-In cohort or the 1st subject enrolled if the site did not utilize Roll-In subjects.
The Primary Cohort was analyzed as two separate sub-cohorts: Intention-to-Treat and Per Protocol. The Intention-to-Treat Cohort includes all subjects that were enrolled. The Per Protocol Cohort includes subjects who were enrolled, and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the Intention-to-Treat Cohort.
The Primary Per Protocol Cohort was the cohort used to determine if the primary endpoints of the VISION Study were met.
|
Roll-in Cohort
Atherectomy with Pantheris System: The Roll-In Cohort consists of either the 1st subject or 1st and 2nd subjects treated at each site prior to enrollment of subjects into the Primary Cohort. Roll-Ins were designed to provide the Investigator an opportunity to gain experience with the Pantheris System (Catheter and Optical Coherence Tomography-assisted orientation) for learning curve purposes. Certain sites were exempt from enrolling in the Roll-In Cohort.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
28
|
|
Overall Study
Treated w Study Device
|
130
|
28
|
|
Overall Study
30-Day Follow-up
|
128
|
27
|
|
Overall Study
6-Month Follow-up
|
125
|
26
|
|
Overall Study
COMPLETED
|
125
|
26
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
Primary Cohort
The Primary Cohort consisted of either the 1st subject enrolled after the Roll-In cohort or the 1st subject enrolled if the site did not utilize Roll-In subjects.
The Primary Cohort was analyzed as two separate sub-cohorts: Intention-to-Treat and Per Protocol. The Intention-to-Treat Cohort includes all subjects that were enrolled. The Per Protocol Cohort includes subjects who were enrolled, and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the Intention-to-Treat Cohort.
The Primary Per Protocol Cohort was the cohort used to determine if the primary endpoints of the VISION Study were met.
|
Roll-in Cohort
Atherectomy with Pantheris System: The Roll-In Cohort consists of either the 1st subject or 1st and 2nd subjects treated at each site prior to enrollment of subjects into the Primary Cohort. Roll-Ins were designed to provide the Investigator an opportunity to gain experience with the Pantheris System (Catheter and Optical Coherence Tomography-assisted orientation) for learning curve purposes. Certain sites were exempt from enrolling in the Roll-In Cohort.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Not treated w device, per protocol fail
|
4
|
0
|
Baseline Characteristics
Evaluation of the Pantheris Atherectomy System
Baseline characteristics by cohort
| Measure |
Primary Cohort
n=134 Participants
The Primary Cohort consisted of either the 1st subject enrolled after the Roll-In cohort or the 1st subject enrolled if the site did not utilize Roll-In subjects.
The Primary Cohort was analyzed as two separate sub-cohorts: Intention-to-Treat and Per Protocol. The Intention-to-Treat Cohort includes all subjects that were enrolled. The Per Protocol Cohort includes subjects who were enrolled, and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the Intention-to Treat-Cohort.
The Primary Per Protocol Cohort was the cohort used to determine if the primary endpoints of the VISION Study were met.
|
Roll-In Cohort
n=28 Participants
The Roll-In Cohort consists of either the 1st subject or 1st and 2nd subjects treated at each site prior to enrollment of subjects into the Primary Cohort. Roll-Ins were designed to provide the Investigator an opportunity to gain experience with the Pantheris System (Catheter and Optical Coherence Tomography-assisted orientation) for learning curve purposes. Certain sites were exempt from enrolling in the Roll-In Cohort.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
80 participants
n=5 Participants
|
20 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
35 participants
n=5 Participants
|
8 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Unavailable
|
9 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=5 Participants
|
28 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
0 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Weight
|
179.5 pounds
STANDARD_DEVIATION 43.0 • n=5 Participants
|
199.3 pounds
STANDARD_DEVIATION 45.3 • n=7 Participants
|
182.9 pounds
STANDARD_DEVIATION 44.0 • n=5 Participants
|
|
Height
|
66.8 inches
STANDARD_DEVIATION 3.8 • n=5 Participants
|
66.5 inches
STANDARD_DEVIATION 4.1 • n=7 Participants
|
66.7 inches
STANDARD_DEVIATION 3.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 6 MonthsPopulation: Per Protocol: Four Subjects withdrew, 1 subject died (non-CV related), so N=125 instead of 130. Intention-to-Treat: Four subjects who were not treated with Pantheris Catheter were exited from the study after the 30-day visit per protocol. Four subjects withdrew, 1 subject died (non-CV related), so N=125 instead of 134.
The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include: 1. Cardiovascular related death 2. Unplanned, major index limb amputation 3. Clinically driven target lesion revascularization (TLR) 4. Myocardial infarction 5. Device related events: 1. Clinically significant perforation 2. Clinically significant dissection 3. Clinically significant embolus 4. Pseudoaneurysm
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=125 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=125 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Primary Safety Endpoint
|
82.4 percentage of subjects
|
82.4 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 0Population: Analyses were performed on 'Primary Cohort: Per Protocol' and 'Primary Cohort: Intention-to-Treat', and results were calculated based on number of lesions that were treated.
The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis \<50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=164 lesions
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=168 lesions
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Primary Effectiveness Endpoint: Technical Success
|
96.3 percentage of lesions
|
94.0 percentage of lesions
|
SECONDARY outcome
Timeframe: Day 0 through Day 30Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=130 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=134 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Safety Endpoint
|
93.1 percentage of subjects
|
93.3 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 0 through 30 daysFreedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=130 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=134 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Safety Endpoint
|
97.7 Percentage of subjects
Interval 93.4 to 99.5
|
97.8 Percentage of subjects
Interval 93.6 to 99.5
|
SECONDARY outcome
Timeframe: Day 0 through 6 MonthsPopulation: Per Protocol: Four Subjects withdrew, 1 subject died (non-CV related), so N=125 instead of 130. Intention-to-Treat: Four subjects who were not treated with Pantheris Catheter were exited from the study after the 30-day visit per protocol. Four subjects withdrew, 1 subject died (non-CV related), so N=125 instead of 134.
Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=125 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=125 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Safety Endpoint
|
91.2 Percentage of subjects
Interval 84.8 to 95.5
|
91.2 Percentage of subjects
Interval 84.8 to 95.5
|
SECONDARY outcome
Timeframe: Day 0Population: Intention-to-Treat: Angiograms post-adjunctive treatment were not available for one subject. So N=133 participants analyzed instead of 134.
Procedural success defined as the percent of target lesions that have residual diameter stenosis \< 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory.
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=164 Number of lesions
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=167 Number of lesions
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Effectiveness Endpoint: Procedural Success
|
78.7 percentage of lesions
|
79.0 percentage of lesions
|
SECONDARY outcome
Timeframe: Day 30Population: Per Protocol: Data unknown for 18 subjects. Intention-to-Treat: Data unknown for 18 subjects.
Ankle-Brachial Index (ABI) at 30 days. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=112 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=116 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Effectiveness Endpoint: ABI
|
0.95 Index
Standard Deviation 0.16
|
0.95 Index
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Day 30Population: Per Protocol: Data unknown for 9 subjects. Intention-to-Treat: Data unknown for 9 subjects.
Rutherford Classification at 30 days. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=121 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=125 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 0 - Asymptomatic
|
52.9 Percentage of subjects
|
52.8 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 1 - Mild Claudication
|
31.4 Percentage of subjects
|
31.2 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 2 - Moderate Claudication
|
10.7 Percentage of subjects
|
10.4 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 3 - Severe Claudication
|
4.1 Percentage of subjects
|
4.8 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 4 - Ischemic Rest Pain
|
0 Percentage of subjects
|
0 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 5 - Minor Tissue Loss
|
0.8 Percentage of subjects
|
0.8 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 6 - Major Tissue Loss
|
0 Percentage of subjects
|
0 Percentage of subjects
|
SECONDARY outcome
Timeframe: Day 30Population: Per Protocol: Baseline: Data unknown for 5 subjects. Per Protocol: 30-Day: Data unknown for 10 subjects. Intention-to-Treat: Baseline: Data unknown for 5 subjects. Intention-to-Treat: 30-Day: Data unknown for 10 subjects.
Change in Quality of Life measures between Baseline and 30 days using 12-Item Short Form Survey (SF-12). There are two components of the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=130 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=134 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Mean SF-12 Mental Component Score: Baseline
|
50.0 Score on a scale
Standard Deviation 10.3
|
50.3 Score on a scale
Standard Deviation 10.3
|
|
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Mean SF-12 Mental Component Score: 30-Day
|
52.1 Score on a scale
Standard Deviation 9.3
|
52.4 Score on a scale
Standard Deviation 9.3
|
|
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Mean SF-12 Physical Component Score: Baseline
|
35.6 Score on a scale
Standard Deviation 8.7
|
35.5 Score on a scale
Standard Deviation 8.6
|
|
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Mean SF-12 Physical Component Score: 30-Day
|
41.5 Score on a scale
Standard Deviation 10.5
|
41.5 Score on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Day 30Population: Per Protocol: 30-Day: Data unknown for 8 subjects. Intention-to-Treat: 30-Day: Data unknown for 8 subjects.
Change in Quality of Life measures between Baseline and 30 days using Vascular Quality of Life Questionnaire (VascuQoL). The VascuQoL is a disease-specific questionnaire developed to assess chronic limb ischemia. VascuQol uses a seven-point scale, with 1 representing the worst score and 7 representing the best score.
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=130 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=134 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Mean VascuQoL Score at Baseline
|
4.1 score on a scale
Standard Deviation 1.2
|
4.1 score on a scale
Standard Deviation 1.2
|
|
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Mean VascuQoL Score at 30 Days
|
5.4 score on a scale
Standard Deviation 1.5
|
5.4 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 6 MonthPopulation: Per Protocol: Data unknown for 13 subjects. Intention-to-Treat: Four subjects who were not treated with Pantheris Catheter were exited from the study after the 30-day visit per protocol. Data unknown for remaining 13 subjects.
Ankle-Brachial Index (ABI) at 6 months. ABI is the ratio of blood pressure in the lower legs to the blood pressure in the arms. ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease).
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=117 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=117 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Effectiveness Endpoint: ABI
|
0.85 Index
Standard Deviation 0.23
|
0.85 Index
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 6 MonthPopulation: Per Protocol: Data unknown for 10 subjects. Intention-to-Treat: Four subjects who were not treated with Pantheris Catheter were exited from the study after the 30-day visit per protocol. Data unknown for remaining 10 subjects.
Rutherford Classification at 6 months. Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: asymptomatic, to Class 6: major tissue loss.
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=120 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=120 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 0 - Asymptomatic
|
41.7 Percentage of subjects
|
41.7 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 1 - Mild Claudication
|
29.2 Percentage of subjects
|
29.2 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 2 - Moderate Claudication
|
14.2 Percentage of subjects
|
14.2 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 3 - Severe Claudication
|
11.7 Percentage of subjects
|
11.7 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 4 - Ischemic Rest Pain
|
1.7 Percentage of subjects
|
1.7 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 5 - Minor Tissue Loss
|
1.7 Percentage of subjects
|
1.7 Percentage of subjects
|
|
Secondary Effectiveness Endpoint: Rutherford Classification
Rutherford Classification: 6 - Major Tissue Loss
|
0 Percentage of subjects
|
0 Percentage of subjects
|
SECONDARY outcome
Timeframe: 6 MonthPopulation: Per Protocol: Baseline: Data unknown for 5 subjects. Per Protocol: 6-Month: Data unknown for 13 subjects. Intention-to-Treat: Baseline: Data unknown for 5 subjects. Intention-to-Treat: 6-Month: Four subjects who were not treated with Pantheris Catheter were exited from the study after the 30-day visit per protocol. Data unknown for remaining 13 subjects.
Change in Quality of Life measures between Baseline and 6 Months using 12-Item Short Form Survey (SF-12). There are two components of the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each yields scores from 0 (representing the worst possible debilitation) to 100 (representing no reduction in quality of life).
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=130 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
|
Primary Cohort: Intention-to-Treat
n=134 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
|
|---|---|---|
|
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Mean SF-12 Mental Component Score: Baseline
|
50.0 score on a scale
Standard Deviation 10.3
|
50.3 score on a scale
Standard Deviation 10.3
|
|
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Mean SF-12 Mental Component Score: 6-Month
|
51.0 score on a scale
Standard Deviation 11.0
|
51.0 score on a scale
Standard Deviation 11.0
|
|
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Mean SF-12 Physical Component Score: Baseline
|
35.6 score on a scale
Standard Deviation 8.7
|
35.5 score on a scale
Standard Deviation 8.6
|
|
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
Mean SF-12 Physical Component Score: 6-Month
|
39.3 score on a scale
Standard Deviation 9.7
|
39.3 score on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 6 MonthPopulation: Per Protocol: 6-Month: Data unknown for 13 subjects. Intention-to-Treat: 6-Month: Four subjects who were not treated with Pantheris Catheter were exited from the study after the 30-day visit per protocol. Data unknown for remaining 13 subjects.
Change in Quality of Life measures between Baseline and 6 months using Vascular Quality of Life Questionnaire (VascuQoL). The VascuQoL is a disease-specific questionnaire developed to assess chronic limb ischemia. VascuQol uses a seven-point scale, with 1 representing the worst score and 7 representing the best score.
Outcome measures
| Measure |
Primary Cohort: Per Protocol
n=130 Participants
The 'Primary Cohort: Per Protocol' includes subjects who were enrolled (excluding Roll-in subjects), and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the 'Primary Cohort: Intention-to-Treat'.
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Primary Cohort: Intention-to-Treat
n=134 Participants
The 'Primary Cohort: Intention-to-Treat' includes all subjects enrolled in the study, excluding Roll-in subjects.
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|---|---|---|
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Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Mean VascuQoL Score at Baseline
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4.1 score on a scale
Standard Deviation 1.2
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4.1 score on a scale
Standard Deviation 1.2
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Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
Mean VascuQoL Score at 6 Months
|
5.0 score on a scale
Standard Deviation 1.5
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5.0 score on a scale
Standard Deviation 1.5
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Adverse Events
Primary Cohort
Serious events: 89 serious events
Other events: 22 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Primary Cohort
n=22 participants at risk；n=134 participants at risk
Pantheris System
|
|---|---|
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Vascular disorders
Clinically Driven Target Lesion Revascularization
|
7.5%
10/134 • Number of events 10 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
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Cardiac disorders
Myocardial Infarction
|
2.2%
3/134 • Number of events 3 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
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|
Vascular disorders
Clinically Driven Target Vessel Revascularization
|
1.5%
2/134 • Number of events 2 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
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Surgical and medical procedures
Access Site Complication
|
2.2%
3/134 • Number of events 3 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
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Injury, poisoning and procedural complications
Bleeding (other than access site)
|
2.2%
3/134 • Number of events 3 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Cardiac disorders
Hypotension, sustained
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
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Infections and infestations
Infection
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Loss of distal collateral flow
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Pain, new onset or worsening from baseline
|
2.2%
3/134 • Number of events 3 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Surgical and medical procedures
Perforation, NHLBI Type I or II
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Emboli requiring intervention to resolve acutely
|
2.2%
3/134 • Number of events 3 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Vessel dissection, Grade C or greater
|
2.2%
3/134 • Number of events 3 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Pseudoaneurysm defined as device related disruption of the arterial wall
|
1.5%
2/134 • Number of events 2 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
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|
Surgical and medical procedures
Vessel dissection, Grade A or B
|
3.0%
4/134 • Number of events 4 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
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|
Vascular disorders
Thrombosis
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Surgical and medical procedures
Unplanned Limb Amputation (Minor or Non-Target Limb)
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Other, Abrasion/Cellutitis (R) UE
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Other, Acute Bronchitis
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Acute Bronchitis
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.5%
2/134 • Number of events 2 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Blood and lymphatic system disorders
Acute on Chronic Anemia
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Renal and urinary disorders
Acute on Chronic Kidney Injury
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Cardiac disorders
Acute on Chronic Systolic Congestive Heart Failure Exacerbation
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Renal and urinary disorders
Acute Renal Failure (CR 1.06)
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Altered Mental Status Due to Hypoglycemia
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Atypical Chest Pain
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Cardiac disorders
Bradycardia
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
BTK PAD RLE
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Skin and subcutaneous tissue disorders
Burn to Left Heel
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Chest Pain
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Chest Pain Syndrome of Unknown Etiology
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Cardiac disorders
Congestive Heart Failure
|
1.5%
2/134 • Number of events 2 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Community Acquired RUL Pneumonia
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Musculoskeletal and connective tissue disorders
Degenerative Joint Disease
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Cardiac disorders
Diastolic Heart Failure
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Difficulty Swallowing
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Dyspnea
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Dyspnea on Extertion
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Cardiac disorders
Episodic Atrial Fibrillation
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Infections and infestations
Gangrenous Changes to Bilateral Metatarsals
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Injury, poisoning and procedural complications
Head Trauma S/P Substantial Fall
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Hypertensive Crisis
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Hypoglycemia
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Hypokalemia
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Intermittent Chest Discomfort
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Intervention Of Contralateral Leg
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Musculoskeletal and connective tissue disorders
Left Patella Fracture
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Blood and lymphatic system disorders
Mild Leukocytosis
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Multi-organ Failure
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Nausea
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Non Target Revascularization
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Cardiac disorders
NSTEMI
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
PAD-LSFA
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Pain - Right Upper Chest
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Infections and infestations
Pneumonia
|
0.75%
1/134 • Number of events 2 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Infections and infestations
Poor Healing Bilateral TMA Wounds Including Infection and Dehiscence
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Pseudoaneurysm at Non-Index Procedure
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Reperfusion Edema
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Cardiac disorders
Respiratory Failure
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Blood and lymphatic system disorders
Right Anterior Tibia Hematoma
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Right Leg Ischemia
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Infections and infestations
RLE Abscess on Shin
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Infections and infestations
Septic Schock
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Shortness of Breath Due to Influenza A
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Stenosis Contralateral (Right) Leg
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Vascular disorders
Stenosis of Left Common Fem Artery Following Procedure
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Surgical and medical procedures
TIA Before Admission
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Skin and subcutaneous tissue disorders
Ulcer Right Heel
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Surgical and medical procedures
Unplanned, Nontarget Limb Intervention
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Urinary Retension
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Infections and infestations
Urinary Tract Infection
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
General disorders
Vomiting
|
0.75%
1/134 • Number of events 1 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
Other adverse events
| Measure |
Primary Cohort
n=22 participants at risk；n=134 participants at risk
Pantheris System
|
|---|---|
|
General disorders
Pain, New Onset or Worsening from Baseline
|
63.6%
14/22 • Number of events 17 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
|
Surgical and medical procedures
Access Site Complication
|
36.4%
8/22 • Number of events 8 • All subjects between enrollment and 6 month follow-up.
There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the earliest of (a)publication of results, (b)receipt of notice stating that Study has been terminated or (c)18 months after completion or termination, Institution/Investigator (IN) shall have right to publish information \& data collected or produced, provided that drafts are provided to Sponsor (SP) at least 60 days prior to the first submission. SP shall comment within 45 days. IN shall delay publication/presentation to enable SP to secure patent or other proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER