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The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured by comparison to Surgical Bypass data derived from a retrospective study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP1101 | Experimental | Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft |
|
| Retrospective Surgical Bypass Outcomes | No Intervention | Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion werer established to be consistent with the experimental arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP1101 | Device | Endovascular stent graft implantation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Assisted Patency | Primary Efficacy Endpoint > > Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion | 12 months |
| Duration of Stay | Duration (in days) of post-procedure hospital stay | Up to discharge |
| Rate of Avoidance of General Anesthesia | Percentage of study subjects avoiding general anesthesia | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb) | Composite endpoint of all subjects experiencing death, target vessel revascularization and/or a major amputation of the target limb (above transmetatarsals) within one month of the index procedure. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takao Ohki, MD | Jikei Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Shinshu University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34182032 | Derived | Ohki T, Kichikawa K, Yokoi H, Iida O, Yamaoka T, Maeda K, Kanaoka Y. Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery. J Vasc Surg. 2021 Dec;74(6):1958-1967.e2. doi: 10.1016/j.jvs.2021.05.056. Epub 2021 Jun 26. | |
| 28400218 |
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133 participants were enrolled into the GP1101 arm; 14 were training cases, 16 were excluded by the Case Conference Committee; total participants started was 103. Retrospective Surgical Bypass Outcomes represent historical controls (n=68).
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| ID | Title | Description |
|---|---|---|
| FG000 | GP1101 | Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft > > GP1101: Endovascular Device Implantation |
| FG001 | Retrospective Surgical Bypass Outcomes | Retrospective data collection (Apr 2012 - Apr 2014) surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GP1101 | Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft |
| BG001 | Retrospective Surgical Bypass Outcomes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Assisted Patency | Primary Efficacy Endpoint > > Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion | Posted | Count of Participants | Participants | 12 months |
|
|
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Adverse events were systematically reported on Case Report Forms
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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 | GP1101 | Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse drug reaction | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Takao Ohki | Toyko Jikei University Hospital | 81-090-2478-8304 | takohki@msn.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D003251 | Constriction, Pathologic |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | 1 month |
| Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown at 12 months. | 3 months |
| Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | 6 months |
| Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | 12 months |
| Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | 24 months |
| Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | 36 months |
| Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | 48 months |
| Rate of Avoidance of Adverse Events | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | 60 months |
| Technical Success | Placement of GP1101 with residual stenosis of less than 30% | Post-procedure |
| Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | 1 month |
| Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | 3 months |
| Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | 6 months |
| Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | 12 months |
| Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | 24 months |
| Secondary Patency | No bypass surgery and no occlusion at the target site | 1 month |
| Secondary Patency | No bypass surgery and no occlusion at the target site | 3 months |
| Secondary Patency | No bypass surgery and no occlusion at the target site | 6 months |
| Secondary Patency | No bypass surgery and no occlusion at the target site | 12 months |
| Secondary Patency | No bypass surgery and no occlusion at the target site | 24 months |
| Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | 1 month |
| Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | 3 months |
| Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | 6 months |
| Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | 12 months |
| Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | 24 months |
| Avoidance of Target Lesion Revascularization | 1 month |
| Avoidance of Target Lesion Revascularization | 3 months |
| Avoidance of Target Lesion Revascularization | 6 months |
| Avoidance of Target Lesion Revascularization | 12 months |
| Avoidance of Target Lesion Revascularization | 24 months |
| Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | 1 month |
| Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | 3 months |
| Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | 6 months |
| Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | 12 months |
| Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | 24 months |
| Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure), | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented |
| Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure) | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented |
| Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure) | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented |
| Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure) | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented |
| Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure) | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented |
| Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | 1 month |
| Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | 3 months |
| Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | 6 months |
| Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | 12 months |
| Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | 24 months |
| Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | 1 month |
| Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | 3 months |
| Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | 6 months |
| Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | 12 months |
| Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | 24 months |
| Rate of Avoidance of Blood Transfusion | Post-Procedure |
| Nagano |
| Asahi, Matsumoto |
| Japan |
| Matsuyama Red Cross Hospital | Matsuyama | Ehime | 790-8524 | Japan |
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | 802-8555 | Japan |
| Tokeidai Memorial Hospital | Sapporo | Hokkaido | 060-0031 | Japan |
| Kansai Rousai Hospital | Amagasaki | Hyōgo | 660-8511 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Kobe Rosai Hospital | Kobe | Hyōgo | 651-0053 | Japan |
| Hyogo College of Medicine Hospital | Nishinomiya | Hyōgo | 663-8501 | Japan |
| National Hospital Organaization Kanazawa Medical Center | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Sendai Kousei Hospital | Sendai | Miyagi | 980-0873 | Japan |
| Kishiwada Tokushukai Hospital | Kishiwada | Osaka | 596-8522 | Japan |
| National Cerebral and Cardiovascular Center | Suita | Osaka | 565-8565 | Japan |
| Nara Medical University Hospital | Nara | 634-8522 | Japan |
| Jikei Medical University Hospital | Tokyo | Japan |
| Ohki T, Kichikawa K, Yokoi H, Uematsu M, Yamaoka T, Maeda K, Kanaoka Y. Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions. J Vasc Surg. 2017 Jul;66(1):130-142.e1. doi: 10.1016/j.jvs.2017.01.065. Epub 2017 Apr 8. |
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Height was not measured in the Retrospective Surgical Bypass Outcomes arm | Mean | Standard Deviation | centimeter |
|
| Weight | Weight was not measured in the Retrospective Surgical Bypass Outcomes arm | Mean | Standard Deviation | kilograms |
|
| BMI | Body Mass Index | BMI was not measured in the Retrospective Surgical Bypass Outcomes arm | Mean | Standard Deviation | kg/㎡ |
|
| Smoking History | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Dyslipidemia | Count of Participants | Participants |
|
| Carotid Disease | Count of Participants | Participants |
|
| Coronary Artery Disease | Count of Participants | Participants |
|
| Myocardial Infarction | Count of Participants | Participants |
|
| Congestive Heart Failure | Count of Participants | Participants |
|
| Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Study Limb | Count of Participants | Participants |
|
| Ankle Brachial Index (ABI) | Eligibility met by TBI for one subject. | Mean | Standard Deviation | Ratio |
|
| Rutherford Category | Count of Participants | Participants |
|
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| Primary | Duration of Stay | Duration (in days) of post-procedure hospital stay | Posted | Median | 95% Confidence Interval | Days | Up to discharge |
|
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| Primary | Rate of Avoidance of General Anesthesia | Percentage of study subjects avoiding general anesthesia | Posted | Count of Participants | Participants | Day 0 |
|
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|
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| Secondary | Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb) | Composite endpoint of all subjects experiencing death, target vessel revascularization and/or a major amputation of the target limb (above transmetatarsals) within one month of the index procedure. | Posted | Count of Participants | Participants | 1 month |
|
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| Secondary | Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | percent of participants | 1 month |
|
|
|
| Secondary | Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown at 12 months. | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Percent of participants | 3 months |
|
|
|
| Secondary | Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | percent of participants | 6 months |
|
|
|
| Secondary | Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | percent of participants | 12 months |
|
|
|
| Secondary | Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | Not Posted | 24 months | Participants |
| Secondary | Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | Not Posted | 36 months | Participants |
| Secondary | Percent of Participants Not Experiencing an Adverse Event | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | Not Posted | 48 months | Participants |
| Secondary | Rate of Avoidance of Adverse Events | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown | Not Posted | 60 months | Participants |
| Secondary | Technical Success | Placement of GP1101 with residual stenosis of less than 30% | Posted | Count of Participants | Participants | Post-procedure |
|
|
|
| Secondary | Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 1 month |
|
|
|
| Secondary | Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 3 months |
|
|
|
| Secondary | Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 6 months |
|
|
|
| Secondary | Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 12 months |
|
|
|
| Secondary | Primary Patency | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization | Not Posted | 24 months | Participants |
| Secondary | Secondary Patency | No bypass surgery and no occlusion at the target site | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 1 month |
|
|
|
| Secondary | Secondary Patency | No bypass surgery and no occlusion at the target site | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 3 months |
|
|
|
| Secondary | Secondary Patency | No bypass surgery and no occlusion at the target site | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 6 months |
|
|
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| Secondary | Secondary Patency | No bypass surgery and no occlusion at the target site | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 12 months |
|
|
|
| Secondary | Secondary Patency | No bypass surgery and no occlusion at the target site | Not Posted | 24 months | Participants |
| Secondary | Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 1 month |
|
|
|
| Secondary | Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 3 months |
|
|
|
| Secondary | Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 6 months |
|
|
|
| Secondary | Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 12 months |
|
|
|
| Secondary | Rate of Avoidance of Stent Fracture | X-ray for stent fracture evaluated by Core Lab | Not Posted | 24 months | Participants |
| Secondary | Avoidance of Target Lesion Revascularization | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 1 month |
|
|
|
| Secondary | Avoidance of Target Lesion Revascularization | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 3 months |
|
|
|
| Secondary | Avoidance of Target Lesion Revascularization | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 6 months |
|
|
|
| Secondary | Avoidance of Target Lesion Revascularization | Kaplan-Meier estimate done at end of follow-up visit window | Posted | Number | 95% Confidence Interval | Probability of having an event | 12 months |
|
|
|
| Secondary | Avoidance of Target Lesion Revascularization | Not Posted | 24 months | Participants |
| Secondary | Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | Posted | Count of Participants | Participants | 1 month |
|
|
|
|
| Secondary | Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | Posted | Count of Participants | Participants | 12 months |
|
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| Secondary | Clinical Success | The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | Not Posted | 24 months | Participants |
| Secondary | Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure), | Posted | Mean | Standard Deviation | ABI | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented |
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| Secondary | Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure) | Posted | Mean | Standard Deviation | ABI | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented |
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| Secondary | Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure) | Posted | Mean | Standard Deviation | ABI | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented |
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| Secondary | Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure) | Posted | Mean | Standard Deviation | ABI | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented |
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| Secondary | Change in Ankle-Brachial Index From Baseline | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure) | Not Posted | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented | Participants |
| Secondary | Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Secondary | Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Secondary | Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Vascular Quality of Life Questionnaire - VascuQOL | VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores. | Not Posted | 24 months | Participants |
| Secondary | Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
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| Secondary | Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Secondary | Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Walking Impairment Questionnaire-WIQ | WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100. | Not Posted | 24 months | Participants |
| Secondary | Rate of Avoidance of Blood Transfusion | Posted | Count of Participants | Participants | Post-Procedure |
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| 47 |
| 103 |
| 41 |
| 103 |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Angina pectoris aggravated | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Anginal attack | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Atrial fibrillation paroxysmal | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Non-sustained ventricular tachycardia | Cardiac disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Bilateral cataracts | Eye disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Cataract aggravated | Eye disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Left cataract | Eye disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Right cataract | Eye disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Acute gastritis | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Haemorrhage of digestive tract | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Right inguinal hernia | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Small intestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Arterial stent occlusion | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Device occlusion | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Hepatic function disorder | Hepatobiliary disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Allergic reaction to antibiotics | Immune system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Acute pneumonia | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| Influenza A virus infection | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| Periodontitis | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| Pulmonary aspergillosis | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| Cataract operation complication | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| Chronic subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| In-stent peripheral artery restenosis | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| Malleolar fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| Peripheral artery restenosis | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| Poisoning by hypnotic | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 15.1 | Systematic Assessment |
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| CRP increased | Investigations | MedDRA Version 15.1 | Systematic Assessment |
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| Potassium abnormal | Investigations | MedDRA Version 15.1 | Systematic Assessment |
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| Sugar blood level increased | Investigations | MedDRA Version 15.1 | Systematic Assessment |
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| Insulin hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Loss of control of blood sugar | Metabolism and nutrition disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Systematic Assessment |
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| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Systematic Assessment |
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| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Systematic Assessment |
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| Malignant neoplasm of lateral wall of oropharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Systematic Assessment |
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| Carotid artery occlusion | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Syncope vasovagal | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Renal failure chronic aggravated | Renal and urinary disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Interstitial pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Femoral artery occlusion | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Iliac artery stenosis | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Thromboembolism | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Vascular occlusion | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Implant site pain | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA Version 15.1 | Systematic Assessment |
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| Common cold | Infections and infestations | MedDRA Version 15.1 | Systematic Assessment |
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| Hypertension aggravated | Vascular disorders | MedDRA Version 15.1 | Systematic Assessment |
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Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| Category 2 - Moderate Claudication |
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| Category 3 - Severe Claudication |
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| Category 4 - Ischemic Rest Pain |
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| Category 5 - Minor Tissue Loss |
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| Category 6- Major Tissue Loss |
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