Peripheral Arterial Disease
Conditions
Keywords
Atherectomy, Optical Coherence Tomography, Lumivascular
Brief summary
A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased lower extremity arteries.
Detailed description
The trial will enroll up to 173 subjects diagnosed with peripheral arterial disease of the lower extremities at up to 20 sites (up to 3 international sites), including 133 Intention to Treat subjects and up to 2 additional Roll-In subjects at each site (up to 40 Roll-In subjects total). The primary disease must be located in reference vessel diameters ≥ 2.5 mm and ≤ 7.0 mm. Trial success is focused on safety including rates of major adverse events through 6 months as adjudicated by a Clinical Events Committee. Effectiveness will be evaluated using technical success, defined as the percent of target lesions that have a residual diameter stenosis \<50% post-treatment with the Pantheris device alone as assessed by Angiographic Core Lab.
Interventions
DEVICEPantheris System
Atherectomy using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.
Sponsors
Avinger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old; * Subject is a candidate for percutaneous intervention for peripheral arterial disease in the legs; * Subject is willing and able to give informed consent; * Documented symptomatic atherosclerotic peripheral arterial disease Rutherford Classification 2-5; * Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by visual estimation; * Subject has de novo target lesion(s) with stenosis \>70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device; * Target lesion length ≤ 15 cm (may be two tandem lesions that do not exceed 15cm in total length); * Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days and 6 months; * At least one patent tibial run-off vessel at baseline. Inclusion Criteria for the 24-month follow up: * Completed the 6-month follow-up visit * Re-consented prior to the 24-month follow-up visit
Exclusion criteria
* Subject is pregnant or breast feeding; * Rutherford Class 0 to 1 (asymptomatic and mild claudication); * Rutherford Class 6 (critical limb ischemia); * Moderate to severe calcification of the target lesion; * Acute ischemia and/or acute thrombosis of the Superficial Femoral Artery (SFA)-Popliteal segment; * In-stent restenosis within the target lesion; * Target lesion with any type of stent or graft; * Target lesion in the iliac artery; * Target lesion stenosis \<70%; * Subjects with significant (≥70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion; * Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure; * Planned endovascular or surgical procedure 30 days after the index procedure; * Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure; * Subjects with active systemic infections whether they are being currently treated or not; * Subjects on chronic hemodialysis or creatinine level \>2.0mg/dL; * Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months; * Evidence or history of aneurysmal target vessel within the past 2 months; * History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days; * Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated; * Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated; * History of heparin-induced thrombocytopenia (HIT); * Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2, known coagulopathy, or International Normalized Ratio (INR) \>1.5; * Any thrombolytic therapy within 2 weeks of the index procedure; * Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject; * Subjects or their legal guardians who have not or will not sign the Informed Consent; * Subjects who are unwilling or unable to comply with the follow-up study requirements; * Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | Day 0 through 6 Months | 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 |
| Primary Effectiveness Endpoint: Technical Success | Day 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoint: ABI | Day 30 | 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). |
| Secondary Effectiveness Endpoint: Rutherford Classification | Day 30 | 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. |
| Secondary Safety Endpoint | Day 0 through Day 30 | Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC. |
| Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL) | Day 30 | 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. |
| Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12) | Day 30 | 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). |
| Secondary Effectiveness Endpoint: Procedural Success | Day 0 | 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. |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 134 |
| Roll-In Cohort 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. | 28 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Not treated w device, per protocol fail | 4 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Primary Cohort | Roll-In Cohort | Total |
|---|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 10.5 | 66.7 years STANDARD_DEVIATION 10.5 | 67.3 years STANDARD_DEVIATION 10.5 |
| Height | 66.8 inches STANDARD_DEVIATION 3.8 | 66.5 inches STANDARD_DEVIATION 4.1 | 66.7 inches STANDARD_DEVIATION 3.8 |
| Race/Ethnicity, Customized African American | 35 participants | 8 participants | 43 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Caucasian | 80 participants | 20 participants | 100 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 8 participants | 0 participants | 8 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Unknown or Unavailable | 9 participants | 0 participants | 9 participants |
| Region of Enrollment Germany | 7 participants | 0 participants | 7 participants |
| Region of Enrollment United States | 127 participants | 28 participants | 155 participants |
| Sex: Female, Male Female | 58 Participants | 13 Participants | 71 Participants |
| Sex: Female, Male Male | 76 Participants | 15 Participants | 91 Participants |
| Weight | 179.5 pounds STANDARD_DEVIATION 43 | 199.3 pounds STANDARD_DEVIATION 45.3 | 182.9 pounds STANDARD_DEVIATION 44 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 134 |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 89 / 134 |
Outcome results
Primary
Primary Effectiveness Endpoint: Technical Success
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.
Time frame: Day 0
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort: Per Protocol | Primary Effectiveness Endpoint: Technical Success | 96.3 percentage of lesions |
| Primary Cohort: Intention-to-Treat | Primary Effectiveness Endpoint: Technical Success | 94.0 percentage of lesions |
Primary
Primary Safety Endpoint
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
Time frame: Day 0 through 6 Months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort: Per Protocol | Primary Safety Endpoint | 82.4 percentage of subjects |
| Primary Cohort: Intention-to-Treat | Primary Safety Endpoint | 82.4 percentage of subjects |
Secondary
Secondary Effectiveness Endpoint: ABI
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).
Time frame: 6 Month
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: ABI | 0.85 Index | Standard Deviation 0.23 |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: ABI | 0.85 Index | Standard Deviation 0.23 |
Secondary
Secondary Effectiveness Endpoint: ABI
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).
Time frame: Day 30
Population: Per Protocol: Data unknown for 18 subjects. Intention-to-Treat: Data unknown for 18 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: ABI | 0.95 Index | Standard Deviation 0.16 |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: ABI | 0.95 Index | Standard Deviation 0.16 |
Secondary
Secondary Effectiveness Endpoint: Procedural Success
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.
Time frame: Day 0
Population: Intention-to-Treat: Angiograms post-adjunctive treatment were not available for one subject. So N=133 participants analyzed instead of 134.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Procedural Success | 78.7 percentage of lesions |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Procedural Success | 79.0 percentage of lesions |
Secondary
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
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).
Time frame: Day 30
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Intention-to-Treat | 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 10.4 |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12) | Mean SF-12 Mental Component Score: Baseline | 50.3 Score on a scale | Standard Deviation 10.3 |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12) | Mean SF-12 Physical Component Score: Baseline | 35.5 Score on a scale | Standard Deviation 8.6 |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12) | Mean SF-12 Mental Component Score: 30-Day | 52.4 Score on a scale | Standard Deviation 9.3 |
Secondary
Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12)
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).
Time frame: 6 Month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Intention-to-Treat | 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 |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12) | Mean SF-12 Mental Component Score: Baseline | 50.3 score on a scale | Standard Deviation 10.3 |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Quality of Life - 12-Item Short Form Survey (SF-12) | Mean SF-12 Physical Component Score: Baseline | 35.5 score on a scale | Standard Deviation 8.6 |
| Primary Cohort: Intention-to-Treat | 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 |
Secondary
Secondary Effectiveness Endpoint: Rutherford Classification
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.
Time frame: Day 30
Population: Per Protocol: Data unknown for 9 subjects. Intention-to-Treat: Data unknown for 9 subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 1 - Mild Claudication | 31.4 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 4 - Ischemic Rest Pain | 0 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 2 - Moderate Claudication | 10.7 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 5 - Minor Tissue Loss | 0.8 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 0 - Asymptomatic | 52.9 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 6 - Major Tissue Loss | 0 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 3 - Severe Claudication | 4.1 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 6 - Major Tissue Loss | 0 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 0 - Asymptomatic | 52.8 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 2 - Moderate Claudication | 10.4 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 3 - Severe Claudication | 4.8 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 4 - Ischemic Rest Pain | 0 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 5 - Minor Tissue Loss | 0.8 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 1 - Mild Claudication | 31.2 Percentage of subjects |
Secondary
Secondary Effectiveness Endpoint: Rutherford Classification
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.
Time frame: 6 Month
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 2 - Moderate Claudication | 14.2 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 4 - Ischemic Rest Pain | 1.7 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 1 - Mild Claudication | 29.2 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 5 - Minor Tissue Loss | 1.7 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 3 - Severe Claudication | 11.7 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 6 - Major Tissue Loss | 0 Percentage of subjects |
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 0 - Asymptomatic | 41.7 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 6 - Major Tissue Loss | 0 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 0 - Asymptomatic | 41.7 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 1 - Mild Claudication | 29.2 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 2 - Moderate Claudication | 14.2 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 3 - Severe Claudication | 11.7 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 4 - Ischemic Rest Pain | 1.7 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Rutherford Classification | Rutherford Classification: 5 - Minor Tissue Loss | 1.7 Percentage of subjects |
Secondary
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
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.
Time frame: Day 30
Population: Per Protocol: 30-Day: Data unknown for 8 subjects. Intention-to-Treat: 30-Day: Data unknown for 8 subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL) | Mean VascuQoL Score at Baseline | 4.1 score on a scale | Standard Deviation 1.2 |
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL) | Mean VascuQoL Score at Baseline | 4.1 score on a scale | Standard Deviation 1.2 |
| Primary Cohort: Intention-to-Treat | 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 |
Secondary
Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL)
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.
Time frame: 6 Month
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort: Per Protocol | Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL) | Mean VascuQoL Score at Baseline | 4.1 score on a scale | Standard Deviation 1.2 |
| Primary Cohort: Per Protocol | 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 |
| Primary Cohort: Intention-to-Treat | Secondary Effectiveness Endpoint: Vascular Quality of Life Questionnaire (VascuQoL) | Mean VascuQoL Score at Baseline | 4.1 score on a scale | Standard Deviation 1.2 |
| Primary Cohort: Intention-to-Treat | 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 |
Secondary
Secondary Safety Endpoint
Freedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.
Time frame: Day 0 through 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort: Per Protocol | Secondary Safety Endpoint | 97.7 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Safety Endpoint | 97.8 Percentage of subjects |
Secondary
Secondary Safety Endpoint
Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.
Time frame: Day 0 through Day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort: Per Protocol | Secondary Safety Endpoint | 93.1 percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Safety Endpoint | 93.3 percentage of subjects |
Secondary
Secondary Safety Endpoint
Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.
Time frame: Day 0 through 6 Months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort: Per Protocol | Secondary Safety Endpoint | 91.2 Percentage of subjects |
| Primary Cohort: Intention-to-Treat | Secondary Safety Endpoint | 91.2 Percentage of subjects |