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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pantheris Treatment Arm | Experimental | Intervention: Atherectomy using the Pantheris system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantheris System | Device | Atherectomy using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 0 through 6 Months |
| 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. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoint | Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC. | Day 0 through Day 30 |
| Secondary Safety Endpoint |
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Inclusion Criteria:
Inclusion Criteria for the 24-month follow up:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gray Bennett, MD | Jackson Heart Clinic | Principal Investigator |
| Billy Crowder, MD | Jackson Heart Clinic | Principal Investigator |
| Arne Schwindt, MD | Muenster Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Bernard's Medical Center | Jonesboro | Arkansas | 72401 | United States | ||
| Arkansas Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28393673 | Derived | Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, Tedder B, Davis TP, Cawich IM, Gammon RS, Muck PE, Pigott JP, Dishmon DA, Lopez LA, Golzar JA, Chamberlin JR, Moulton MJ, Zakir RM, Kaki AK, Fishbein GJ, McDaniel HB, Hezi-Yamit A, Simpson JB, Desai A. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther. 2017 Jun;24(3):355-366. doi: 10.1177/1526602817701720. Epub 2017 Apr 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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Freedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.
| Day 0 through 30 days |
| Secondary Safety Endpoint | Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC. | Day 0 through 6 Months |
| 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. | Day 0 |
| 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). | Day 30 |
| 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. | Day 30 |
| 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). | Day 30 |
| 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. | Day 30 |
| 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). | 6 Month |
| 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. | 6 Month |
| 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). | 6 Month |
| 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. | 6 Month |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Cedars Sinai Medical Center/Cardiovascular Research Foundation of Southern California | West Hollywood | California | 90048 | United States |
| Medstar Washington Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| Coastal Vascular and Interventional | Pensacola | Florida | 32501 | United States |
| Alexian Brothers Medical Center, Cardiovascular Associates | Elk Grove Village | Illinois | 60007 | United States |
| Advocate Christ Hospital and Medical Center | Oak Lawn | Illinois | 60453 | United States |
| St. Joseph's Hospital | Fort Wayne | Indiana | 46802 | United States |
| Detroit Medical Center Cardiovascular Institute Harper-Hutzel Hospital | Detroit | Michigan | 48201 | United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| St. Dominic Hospital | Jackson | Mississippi | 39216 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| St. Peters University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Hatton Institute for Research and Education, Good Samaritan Hospital - Bethesda North | Cincinnati | Ohio | 45220 | United States |
| Dayton Heart Center/Good Samaritan Hospital | Dayton | Ohio | 45414 | United States |
| Jobst Vascular Center | Toledo | Ohio | 43606 | United States |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Methodist Hospital | Memphis | Tennessee | 38116 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| Muenster Hospital | Münster | 48145 | Germany |
| FG001 | 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. |
|
| Treated w Study Device | Per Protocol |
|
| 30-Day Follow-up |
|
| 6-Month Follow-up |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The study consisted of Roll-In Cohort and a Primary Analysis Cohort. Up to 2 Roll-In subjects could be treated at each study site prior to initiation of enrollment in the Primary Analysis Cohort.Roll-In subjects were designed to provide the Investigator an opportunity to gain experience with the Pantheris System for learning curve purposes.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Subject age in years | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | pounds |
| |||||||||||||||
| Height | Mean | Standard Deviation | inches |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| 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. | Posted | Number | percentage of subjects | Day 0 through 6 Months |
|
|
| |||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of lesions | Day 0 | lesions | lesions |
|
| ||||||||||||||||||||||||||||
| 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. | Posted | Number | percentage of subjects | Day 0 through Day 30 |
|
| |||||||||||||||||||||||||||||||
| 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. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 0 through 30 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Secondary Safety Endpoint | Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC. | 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. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 0 through 6 Months |
|
| |||||||||||||||||||||||||||||
| 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. | Intention-to-Treat: Angiograms post-adjunctive treatment were not available for one subject. So N=133 participants analyzed instead of 134. | Posted | Number | percentage of lesions | Day 0 | Number of lesions | Number of lesions |
|
| ||||||||||||||||||||||||||||
| 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). | Per Protocol: Data unknown for 18 subjects. Intention-to-Treat: Data unknown for 18 subjects. | Posted | Mean | Standard Deviation | Index | Day 30 |
|
| |||||||||||||||||||||||||||||
| 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. | Per Protocol: Data unknown for 9 subjects. Intention-to-Treat: Data unknown for 9 subjects. | Posted | Number | Percentage of subjects | Day 30 |
|
| ||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Day 30 |
| ||||||||||||||||||||||||||||||
| 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. | Per Protocol: 30-Day: Data unknown for 8 subjects. Intention-to-Treat: 30-Day: Data unknown for 8 subjects. | Posted | Mean | Standard Deviation | score on a scale | Day 30 |
|
| |||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | Index | 6 Month |
|
| |||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Percentage of subjects | 6 Month |
| |||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Month |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Month |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Cohort | Pantheris System | 5 | 134 | 89 | 134 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically Driven Target Lesion Revascularization | Vascular disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Clinically Driven Target Vessel Revascularization | Vascular disorders | Systematic Assessment |
| ||
| Access Site Complication | Surgical and medical procedures | Systematic Assessment |
| ||
| Bleeding (other than access site) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hypotension, sustained | Cardiac disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Loss of distal collateral flow | Vascular disorders | Systematic Assessment |
| ||
| Pain, new onset or worsening from baseline | Vascular disorders | Systematic Assessment |
| ||
| Perforation, NHLBI Type I or II | Surgical and medical procedures | Systematic Assessment |
| ||
| Emboli requiring intervention to resolve acutely | Vascular disorders | Systematic Assessment |
| ||
| Vessel dissection, Grade C or greater | Vascular disorders | Systematic Assessment |
| ||
| Pseudoaneurysm defined as device related disruption of the arterial wall | Vascular disorders | Systematic Assessment |
| ||
| Vessel dissection, Grade A or B | Surgical and medical procedures | Systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Unplanned Limb Amputation (Minor or Non-Target Limb) | Surgical and medical procedures | Systematic Assessment |
| ||
| Other, Abrasion/Cellutitis (R) UE | Vascular disorders | Systematic Assessment |
| ||
| Other, Acute Bronchitis | General disorders | Systematic Assessment |
| ||
| Acute Bronchitis | General disorders | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute on Chronic Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute on Chronic Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute on Chronic Systolic Congestive Heart Failure Exacerbation | Cardiac disorders | Systematic Assessment |
| ||
| Acute Renal Failure (CR 1.06) | Renal and urinary disorders | Systematic Assessment |
| ||
| Altered Mental Status Due to Hypoglycemia | General disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atypical Chest Pain | General disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
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| BTK PAD RLE | Vascular disorders | Systematic Assessment |
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| Burn to Left Heel | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Chest Pain Syndrome of Unknown Etiology | General disorders | Systematic Assessment |
| ||
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Community Acquired RUL Pneumonia | General disorders | Systematic Assessment |
| ||
| Degenerative Joint Disease | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Diastolic Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Difficulty Swallowing | General disorders | Systematic Assessment |
| ||
| Dyspnea | General disorders | Systematic Assessment |
| ||
| Dyspnea on Extertion | General disorders | Systematic Assessment |
| ||
| Episodic Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Gangrenous Changes to Bilateral Metatarsals | Infections and infestations | Systematic Assessment |
| ||
| Head Trauma S/P Substantial Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypertensive Crisis | General disorders | Systematic Assessment |
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| Hypoglycemia | General disorders | Systematic Assessment |
| ||
| Hypokalemia | General disorders | Systematic Assessment |
| ||
| Intermittent Chest Discomfort | General disorders | Systematic Assessment |
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| Intervention Of Contralateral Leg | Vascular disorders | Systematic Assessment |
| ||
| Left Patella Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Mild Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Multi-organ Failure | General disorders | Systematic Assessment |
| ||
| Nausea | General disorders | Systematic Assessment |
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| Non Target Revascularization | Vascular disorders | Systematic Assessment |
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| NSTEMI | Cardiac disorders | Systematic Assessment |
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| PAD-LSFA | Vascular disorders | Systematic Assessment |
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| Pain - Right Upper Chest | General disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Poor Healing Bilateral TMA Wounds Including Infection and Dehiscence | Infections and infestations | Systematic Assessment |
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| Pseudoaneurysm at Non-Index Procedure | Vascular disorders | Systematic Assessment |
| ||
| Reperfusion Edema | Vascular disorders | Systematic Assessment |
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| Respiratory Failure | Cardiac disorders | Systematic Assessment |
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| Right Anterior Tibia Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
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| Right Leg Ischemia | Vascular disorders | Systematic Assessment |
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| RLE Abscess on Shin | Infections and infestations | Systematic Assessment |
| ||
| Septic Schock | Infections and infestations | Systematic Assessment |
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| Shortness of Breath Due to Influenza A | General disorders | Systematic Assessment |
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| Stenosis Contralateral (Right) Leg | Vascular disorders | Systematic Assessment |
| ||
| Stenosis of Left Common Fem Artery Following Procedure | Vascular disorders | Systematic Assessment |
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| TIA Before Admission | Surgical and medical procedures | Systematic Assessment |
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| Ulcer Right Heel | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Unplanned, Nontarget Limb Intervention | Surgical and medical procedures | Systematic Assessment |
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| Urinary Retension | General disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Vomiting | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain, New Onset or Worsening from Baseline | General disorders | Systematic Assessment |
| ||
| Access Site Complication | Surgical and medical procedures | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Lawson | Avinger | 650.241.7030 | tlawson@avinger.com |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
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| Male |
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| African American |
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| Other |
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| Unknown or Unavailable |
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