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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Endovascular stent graft implantation
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Shinshu University Hospital
Nagano, Asahi, Matsumoto, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
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
Time frame: 12 months
Duration of Stay
Duration (in days) of post-procedure hospital stay
Time frame: Up to discharge
Rate of Avoidance of General Anesthesia
Percentage of study subjects avoiding general anesthesia
Time frame: Day 0
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.
Time frame: 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
Time frame: 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.
Time frame: 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
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Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Tokeidai Memorial Hospital
Sapporo, Hokkaido, Japan
Kansai Rousai Hospital
Amagasaki, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kobe Rosai Hospital
Kobe, Hyōgo, Japan
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, Japan
National Hospital Organaization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, Japan
...and 5 more locations
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 60 months
Technical Success
Placement of GP1101 with residual stenosis of less than 30%
Time frame: Post-procedure
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 1 month
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 3 months
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 6 months
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 12 months
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 24 months
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 1 month
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 3 months
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 6 months
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 12 months
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 24 months
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 1 month
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 3 months
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 6 months
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 12 months
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 24 months
Avoidance of Target Lesion Revascularization
Time frame: 1 month
Avoidance of Target Lesion Revascularization
Time frame: 3 months
Avoidance of Target Lesion Revascularization
Time frame: 6 months
Avoidance of Target Lesion Revascularization
Time frame: 12 months
Avoidance of Target Lesion Revascularization
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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),
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Rate of Avoidance of Blood Transfusion
Time frame: Post-Procedure