Peripheral Arterial DiseaseVJH11-01NCT01575808
Multi-center Study for Stent Graft System for Peripheral Artery
A study testing GP1101 in people with Peripheral Arterial Disease, run by W.L.Gore & Associates at 15 sites in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- GP1101
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 15 sitesJapan
- Study dates
- Apr 2012to Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- The ability to comply with the study protocol, follow-up requirements and required testing.
- Surgical bypass candidate
- Qualifying lesions by angiography
Who cannot join
- 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).
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- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Kansai Rousai Hospital
Amagasaki, Hyōgo, 660-8511
National Hospital Organaization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-8522
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Kobe Rosai Hospital
Kobe, Hyōgo, 651-0053
Matsuyama Red Cross Hospital
Matsuyama, Ehime, 790-8524
Shinshu University Hospital
Nagano, Asahi, Matsumoto
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Nara Medical University Hospital
Nara, 634-8522
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, 663-8501
Tokeidai Memorial Hospital
Sapporo, Hokkaido, 060-0031
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873
National Cerebral and Cardiovascular Center
Suita, Osaka, 565-8565
Jikei Medical University Hospital
Tokyo
About this study
Official title: 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- GP1101
- Keywords
- Symptomatic PAD, Stenosis, Occlusion
- Medical subject headings
- Peripheral Arterial Disease, Constriction, Pathologic, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP1101Device
Also called Gore VIABAHN Endoprosthesis
Endovascular stent graft implantation
| Study group | Role | What they receive |
|---|---|---|
| GP1101 | Experimental | Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft Receives: Device: GP1101 |
| Retrospective Surgical Bypass Outcomes | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Duration of Stay
Duration (in days) of post-procedure hospital stay
Measured: Up to discharge
Rate of Avoidance of General Anesthesia
Percentage of study subjects avoiding general anesthesia
Measured: Day 0
Secondary outcomes (51)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 60 months
Technical Success
Placement of GP1101 with residual stenosis of less than 30%
Measured: Post-procedure
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Measured: 1 month
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Measured: 3 months
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Measured: 6 months
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Measured: 12 months
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Measured: 24 months
Secondary Patency
No bypass surgery and no occlusion at the target site
Measured: 1 month
Secondary Patency
No bypass surgery and no occlusion at the target site
Measured: 3 months
Secondary Patency
No bypass surgery and no occlusion at the target site
Measured: 6 months
Secondary Patency
No bypass surgery and no occlusion at the target site
Measured: 12 months
Secondary Patency
No bypass surgery and no occlusion at the target site
Measured: 24 months
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Measured: 1 month
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Measured: 3 months
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Measured: 6 months
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Measured: 12 months
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Measured: 24 months
Avoidance of Target Lesion Revascularization
Measured: 1 month
Avoidance of Target Lesion Revascularization
Measured: 3 months
Avoidance of Target Lesion Revascularization
Measured: 6 months
Avoidance of Target Lesion Revascularization
Measured: 12 months
Avoidance of Target Lesion Revascularization
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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),
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Rate of Avoidance of Blood Transfusion
Measured: Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2014
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takao Ohki, MD, Principal investigator, Jikei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575808
- Sponsor's protocol ID
- JPS 16-02 / VJH11-01
- Acronym
- VJH11-01
- Status last verified
- May 2023
- First submitted
- 9 Apr 2012
- Last updated
- 12 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 34182032Ohki 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.
PubMed 28400218
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01575808
- Acronym / sponsor ID
- VJH11-01 / JPS 16-02 / VJH11-01
- Conditions
- Peripheral Arterial Disease
- Keywords
- Symptomatic PAD, Stenosis, Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Posted 8 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP1101 | Experimental | Device: GP1101Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft |
| Retrospective Surgical Bypass Outcomes | No intervention | –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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP1101Also: Gore VIABAHN EndoprosthesisEndovascular stent graft implantation | Device | GP1101 |
Primary outcome
Primary Assisted Patency
Time frame: 12 months
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
Duration of Stay
Time frame: Up to discharge
Duration (in days) of post-procedure hospital stay
Rate of Avoidance of General Anesthesia
Time frame: Day 0
Percentage of study subjects avoiding general anesthesia
51 secondary outcomes
Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)
Time frame: 1 month
Percent of Participants Not Experiencing an Adverse Event
Time frame: 1 month
Percent of Participants Not Experiencing an Adverse Event
Time frame: 3 months
Percent of Participants Not Experiencing an Adverse Event
Time frame: 6 months
Percent of Participants Not Experiencing an Adverse Event
Time frame: 12 months
Percent of Participants Not Experiencing an Adverse Event
Time frame: 24 months
Percent of Participants Not Experiencing an Adverse Event
Time frame: 36 months
Percent of Participants Not Experiencing an Adverse Event
Time frame: 48 months
Rate of Avoidance of Adverse Events
Time frame: 60 months
Technical Success
Time frame: Post-procedure
Primary Patency
Time frame: 1 month
Primary Patency
Time frame: 3 months
Primary Patency
Time frame: 6 months
Primary Patency
Time frame: 12 months
Primary Patency
Time frame: 24 months
Secondary Patency
Time frame: 1 month
Secondary Patency
Time frame: 3 months
Secondary Patency
Time frame: 6 months
Secondary Patency
Time frame: 12 months
Secondary Patency
Time frame: 24 months
Rate of Avoidance of Stent Fracture
Time frame: 1 month
Rate of Avoidance of Stent Fracture
Time frame: 3 months
Rate of Avoidance of Stent Fracture
Time frame: 6 months
Rate of Avoidance of Stent Fracture
Time frame: 12 months
Rate of Avoidance of Stent Fracture
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
Time frame: 1 month
Clinical Success
Time frame: 3 months
Clinical Success
Time frame: 6 months
Clinical Success
Time frame: 12 months
Clinical Success
Time frame: 24 months
Change in Ankle-Brachial Index From Baseline
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented
Change in Ankle-Brachial Index From Baseline
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented
Change in Ankle-Brachial Index From Baseline
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented
Change in Ankle-Brachial Index From Baseline
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented
Change in Ankle-Brachial Index From Baseline
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34182032Ohki 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.
- Derived from this study: PubMed 28400218Ohki 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.
- Individual participant dataSharing planned: No
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Arterial Thromboembolism, Venous Thromboembolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takao Ohki, MD principal investigator
Jikei Medical University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP1101 in people with Peripheral Arterial Disease, run by W.L.Gore & Associates at 15 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Assisted Patency (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01575808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.