Multi-center Study for Stent Graft System for Peripheral Artery

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: GP1101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rutherford 2-5 category Subject has read, understood and signed written informed consent which has been reviewed and approved by the Institutional Review Board (IRB). At least 20 years of age. Ankle-brachial index (ABI) in the study limb in the non-invasive lower extremity arterial studies within 30 days prior to study procedure or at the time of study procedure is less than or equal to 0.9, or toe-brachial index (TBI) is less than or equal to 0.5. Male, infertile female, or female of child-bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure. Projected life expectancy of greater than 2 years. The ability to comply with the study protocol, follow-up requirements and required testing. Surgical bypass candidate Qualifying lesions by angiography Exclusion Criteria: Untreated flow-limiting aortoiliac disease. Any previous stenting or surgery in the target vessel(i.e. femoro-popliteal artery). Vascular access/catheterization in the target or contralateral limb within 30 days of study enrollment. Planned surgery or intervention within 30 days after study procedure. Femoral artery or popliteal artery aneurysm > 1.5 X healthy adjacent vessel diameter. Non-atherosclerotic disease resulting in stenosis and/or occlusion (e.g., embolism, Buerger's disease, vasculitis). Severe medical comorbidities (untreated CAD/CHF (Congestive Heart Failure), severe COPD (Chronic Obstructive Pulmonary Disease), severe dementia, NYHA (New York Heart Association) 3/4, severe hypertension, etc.) Any medical condition that would preclude post-procedural ambulation or completion of study follow-up. Rutherford 5 patients with active infection. Serum creatinine >2.5 mg/dL within 30 days prior to study procedure. Rutherford 6 category in the study or non-study limb or major tissue loss extending above the proximal phalanx level. Rutherford 5 characteristics in non-study limb. Major distal amputation (above the transmetatarsal) in the study or non-study limb. Active infection that could adversely impact patient outcomes in the study, or any patient with septicemia or bacteremia. Any previously known coagulation disorder, including hypercoagulability. Morbid obesity or operative scarring that precludes percutaneous approach Contraindication to anticoagulation or antiplatelet Known allergies to stent/stent-graft components, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (HIT) type II. Current peritoneal or hemodialysis Participation in another clinical trial (except F/P device clinical trial) up to 3 months prior to study enrollment. Enrollment in a F/P device clinical trial within the last 12 months. Interventional or surgical treatment on arteries distal to the target vessel for this study within the past 12 months. Any other factor identified by the Principal Investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GP1101<br>Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft | Device: GP1101<br>* Endovascular stent graft implantation<br>* Other names: Gore VIABAHN Endoprosthesis;|
| No Intervention: Retrospective Surgical Bypass Outcomes<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptomatic PAD, Stenosis, Occlusion