Multi-center Study for Stent Graft System for Peripheral Artery

Peripheral Arterial Disease Clinical Trial

— VJH11-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575808
• Other study ID #: JPS 16-02 / VJH11-01
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: February 2019

Study information

• Verified date: May 2023
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: February 2019
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• GP1101
Endovascular stent graft implantation

Locations

Country	Name	City	State
Japan	Kansai Rousai Hospital	Amagasaki	Hyogo
Japan	National Hospital Organaization Kanazawa Medical Center	Kanazawa	Ishikawa
Japan	Kishiwada Tokushukai Hospital	Kishiwada	Osaka
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Kobe Rosai Hospital	Kobe	Hyogo
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Matsuyama Red Cross Hospital	Matsuyama	Ehime
Japan	Shinshu University Hospital	Nagano	Asahi, Matsumoto
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Nara Medical University Hospital	Nara
Japan	Hyogo College of Medicine Hospital	Nishinomiya	Hyogo
Japan	Tokeidai Memorial Hospital	Sapporo	Hokkaido
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka
Japan	Jikei Medical University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 months
Primary	Duration of Stay	Duration (in days) of post-procedure hospital stay	Up to discharge
Primary	Rate of Avoidance of General Anesthesia	Percentage of study subjects avoiding general anesthesia	Day 0
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.	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	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.	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	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	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	24 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	36 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	48 months
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	60 months
Secondary	Technical Success	Placement of GP1101 with residual stenosis of less than 30%	Post-procedure
Secondary	Primary Patency	Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization	1 month
Secondary	Primary Patency	Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization	3 months
Secondary	Primary Patency	Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization	6 months
Secondary	Primary Patency	Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization	12 months
Secondary	Primary Patency	Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization	24 months
Secondary	Secondary Patency	No bypass surgery and no occlusion at the target site	1 month
Secondary	Secondary Patency	No bypass surgery and no occlusion at the target site	3 months
Secondary	Secondary Patency	No bypass surgery and no occlusion at the target site	6 months
Secondary	Secondary Patency	No bypass surgery and no occlusion at the target site	12 months
Secondary	Secondary Patency	No bypass surgery and no occlusion at the target site	24 months
Secondary	Rate of Avoidance of Stent Fracture	X-ray for stent fracture evaluated by Core Lab	1 month
Secondary	Rate of Avoidance of Stent Fracture	X-ray for stent fracture evaluated by Core Lab	3 months
Secondary	Rate of Avoidance of Stent Fracture	X-ray for stent fracture evaluated by Core Lab	6 months
Secondary	Rate of Avoidance of Stent Fracture	X-ray for stent fracture evaluated by Core Lab	12 months
Secondary	Rate of Avoidance of Stent Fracture	X-ray for stent fracture evaluated by Core Lab	24 months
Secondary	Avoidance of Target Lesion Revascularization		1 month
Secondary	Avoidance of Target Lesion Revascularization		3 months
Secondary	Avoidance of Target Lesion Revascularization		6 months
Secondary	Avoidance of Target Lesion Revascularization		12 months
Secondary	Avoidance of Target Lesion Revascularization		24 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.	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.	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.	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.	12 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.	24 months
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),	Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented
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)	Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented
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)	Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented
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)	Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented
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)	Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented
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.	1 month
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.	3 months
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.	6 months
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.	12 months
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.	24 months
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.	1 month
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.	3 months
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.	6 months
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.	12 months
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.	24 months
Secondary	Rate of Avoidance of Blood Transfusion		Post-Procedure