Clinical trial NCT01575808: Multi-center Study for Stent Graft System for Peripheral Artery
Official title: The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Symptomatic PAD
Stenosis
Occlusion
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 133
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Primary Assisted Patency
timeFrame: 12 months
measure: Duration of Stay
timeFrame: Up to discharge
measure: Rate of Avoidance of General Anesthesia
timeFrame: Day 0
Secondary outcomes:
measure: Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)
timeFrame: 1 month
measure: Percent of Participants Not Experiencing an Adverse Event
timeFrame: 1 month
measure: Percent of Participants Not Experiencing an Adverse Event
timeFrame: 3 months
measure: Percent of Participants Not Experiencing an Adverse Event
timeFrame: 6 months
measure: Percent of Participants Not Experiencing an Adverse Event
timeFrame: 12 months
measure: Percent of Participants Not Experiencing an Adverse Event
timeFrame: 24 months
measure: Percent of Participants Not Experiencing an Adverse Event
timeFrame: 36 months
measure: Percent of Participants Not Experiencing an Adverse Event
timeFrame: 48 months
measure: Rate of Avoidance of Adverse Events
timeFrame: 60 months
measure: Technical Success
timeFrame: Post-procedure
measure: Primary Patency
timeFrame: 1 month
measure: Primary Patency
timeFrame: 3 months
measure: Primary Patency
timeFrame: 6 months
measure: Primary Patency
timeFrame: 12 months
measure: Primary Patency
timeFrame: 24 months
measure: Secondary Patency
timeFrame: 1 month
measure: Secondary Patency
timeFrame: 3 months
measure: Secondary Patency
timeFrame: 6 months
measure: Secondary Patency
timeFrame: 12 months
measure: Secondary Patency
timeFrame: 24 months
measure: Rate of Avoidance of Stent Fracture
timeFrame: 1 month
measure: Rate of Avoidance of Stent Fracture
timeFrame: 3 months
measure: Rate of Avoidance of Stent Fracture
timeFrame: 6 months
measure: Rate of Avoidance of Stent Fracture
timeFrame: 12 months
measure: Rate of Avoidance of Stent Fracture
timeFrame: 24 months
measure: Avoidance of Target Lesion Revascularization
timeFrame: 1 month
measure: Avoidance of Target Lesion Revascularization
timeFrame: 3 months
measure: Avoidance of Target Lesion Revascularization
timeFrame: 6 months
measure: Avoidance of Target Lesion Revascularization
timeFrame: 12 months
measure: Avoidance of Target Lesion Revascularization
timeFrame: 24 months
measure: Clinical Success
timeFrame: 1 month
measure: Clinical Success
timeFrame: 3 months
measure: Clinical Success
timeFrame: 6 months
measure: Clinical Success
timeFrame: 12 months
measure: Clinical Success
timeFrame: 24 months
measure: Change in Ankle-Brachial Index From Baseline
timeFrame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented
measure: Change in Ankle-Brachial Index From Baseline
timeFrame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented
measure: Change in Ankle-Brachial Index From Baseline
timeFrame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented
measure: Change in Ankle-Brachial Index From Baseline
timeFrame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented
measure: Change in Ankle-Brachial Index From Baseline
timeFrame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented
measure: Vascular Quality of Life Questionnaire - VascuQOL
timeFrame: 1 month
measure: Vascular Quality of Life Questionnaire - VascuQOL
timeFrame: 3 months
measure: Vascular Quality of Life Questionnaire - VascuQOL
timeFrame: 6 months
measure: Vascular Quality of Life Questionnaire - VascuQOL
timeFrame: 12 months
measure: Vascular Quality of Life Questionnaire - VascuQOL
timeFrame: 24 months
measure: Walking Impairment Questionnaire-WIQ
timeFrame: 1 month
measure: Walking Impairment Questionnaire-WIQ
timeFrame: 3 months
measure: Walking Impairment Questionnaire-WIQ
timeFrame: 6 months
measure: Walking Impairment Questionnaire-WIQ
timeFrame: 12 months
measure: Walking Impairment Questionnaire-WIQ
timeFrame: 24 months
measure: Rate of Avoidance of Blood Transfusion
timeFrame: Post-Procedure
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Nagano
country: Japan
facility: Shinshu University Hospital
state: Asahi, Matsumoto
city: Matsuyama
country: Japan
facility: Matsuyama Red Cross Hospital
state: Ehime
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Tokeidai Memorial Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Kansai Rousai Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe Rosai Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: National Hospital Organaization Kanazawa Medical Center
state: Ishikawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Nara
country: Japan
facility: Nara Medical University Hospital
city: Tokyo
country: Japan
facility: Jikei Medical University Hospital
Study officials:
affiliation: Jikei Medical University Hospital
name: Takao Ohki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.