Multi-center Study for Stent Graft System for Peripheral Artery (VJH11-01)

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

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 Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: GP1101

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Nara, Japan, 634-8522
    • Nara Medical University Hospital
  • Tokyo, Japan
    • Jikei Medical University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
      • Nagoya University Hospital
  • Asahi, Matsumoto
    • Nagano, Asahi, Matsumoto, Japan
      • Shinshu University Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 790-8524
      • Matsuyama Red Cross Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0031
      • Tokeidai Memorial Hospital
  • Hyogo
    • Amagasaki, Hyogo, Japan, 660-8511
      • Kansai Rousai Hospital
    • Kobe, Hyogo, Japan, 650-0017
      • Kobe University Hospital
    • Kobe, Hyogo, Japan, 651-0053
      • Kobe Rosai Hospital
    • Nishinomiya, Hyogo, Japan, 663-8501
      • Hyogo College of Medicine Hospital
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8650
      • National Hospital Organaization Kanazawa Medical Center
  • Miyagi
    • Sendai, Miyagi, Japan, 980-0873
      • Sendai Kousei Hospital
  • Osaka
    • Kishiwada, Osaka, Japan, 596-8522
      • Kishiwada Tokushukai Hospital
    • Suita, Osaka, Japan, 565-8565
      • National Cerebral and Cardiovascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Takao Ohki, MD, Jikei Medical University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: April 9, 2012
• First Submitted That Met QC Criteria: April 10, 2012
• First Posted (Estimate): April 11, 2012

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Occlusion; Stenosis; Symptomatic PAD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: JPS 16-02 / VJH11-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO