Peripheral Arterial Disease
Conditions
Keywords
Symptomatic PAD, Stenosis, Occlusion
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.
Interventions
DEVICEGP1101
Endovascular stent graft implantation
Sponsors
W.L.Gore & Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Assisted Patency | 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 | Up to discharge | Duration (in days) of post-procedure hospital stay |
| Rate of Avoidance of General Anesthesia | Day 0 | Percentage of study subjects avoiding general anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Post-procedure | Placement of GP1101 with residual stenosis of less than 30% |
| Primary Patency | 1 month | Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization |
| Secondary Patency | 1 month | No bypass surgery and no occlusion at the target site |
| Rate of Avoidance of Stent Fracture | 1 month | X-ray for stent fracture evaluated by Core Lab |
| Avoidance of Target Lesion Revascularization | 1 month | — |
| Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb) | 1 month | 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. |
| Change in Ankle-Brachial Index From Baseline | Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented | Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure), |
| Vascular Quality of Life Questionnaire - VascuQOL | 1 month | 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. |
| Walking Impairment Questionnaire-WIQ | 1 month | 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. |
| Rate of Avoidance of Blood Transfusion | Post-Procedure | — |
| Clinical Success | 1 month | 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. |
| Percent of Participants Not Experiencing an Adverse Event | 1 month | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown |
| Rate of Avoidance of Adverse Events | 60 months | % Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown |
Countries
Japan
Participant flow
Pre-assignment details
133 participants were enrolled into the GP1101 arm; 14 were training cases, 16 were excluded by the Case Conference Committee; total participants started was 103. Retrospective Surgical Bypass Outcomes represent historical controls (n=68).
Participants by arm
| Arm | Count |
|---|---|
| GP1101 Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft | 103 |
| 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 were established to be consistent with the experimental arm. | 68 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | GP1101 | Total | Retrospective Surgical Bypass Outcomes |
|---|---|---|---|
| Age, Continuous | 74.2 years STANDARD_DEVIATION 7 | 73.4 years STANDARD_DEVIATION 7.6 | 72.3 years STANDARD_DEVIATION 8.3 |
| Ankle Brachial Index (ABI) | 0.64 Ratio STANDARD_DEVIATION 0.12 | 0.57 Ratio STANDARD_DEVIATION 0.18 | 0.47 Ratio STANDARD_DEVIATION 0.2 |
| BMI | 22.5 kg/㎡ STANDARD_DEVIATION 2.83 | 22.5 kg/㎡ STANDARD_DEVIATION 2.83 | — |
| Carotid Disease History of Carotid Disease = No | 90 Participants | 152 Participants | 62 Participants |
| Carotid Disease History of Carotid Disease = Yes | 13 Participants | 19 Participants | 6 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) History of COPD = No | 93 Participants | 157 Participants | 64 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) History of COPD = Yes | 10 Participants | 14 Participants | 4 Participants |
| Congestive Heart Failure HIstory of Congestive Heart Failure = No | 99 Participants | 164 Participants | 65 Participants |
| Congestive Heart Failure History of Congestive Heart Failure = Yes | 4 Participants | 7 Participants | 3 Participants |
| Coronary Artery Disease History of Coronary Artery Disease = No | 61 Participants | 108 Participants | 47 Participants |
| Coronary Artery Disease History of Coronary Artery Disease = Yes | 42 Participants | 63 Participants | 21 Participants |
| Diabetes Mellitus History of Diabetes Mellitus = No | 41 Participants | 75 Participants | 34 Participants |
| Diabetes Mellitus History of Diabetes Mellitus = Yes | 62 Participants | 96 Participants | 34 Participants |
| Dyslipidemia History of Dyslipidemia = No | 39 Participants | 75 Participants | 36 Participants |
| Dyslipidemia History of Dyslipidemia = Yes | 64 Participants | 96 Participants | 32 Participants |
| Height | 161.9 centimeter STANDARD_DEVIATION 8.48 | 161.9 centimeter STANDARD_DEVIATION 8.48 | — |
| Hypertension History of Hypertension = No | 12 Participants | 21 Participants | 9 Participants |
| Hypertension History of Hypertension = Yes | 91 Participants | 150 Participants | 59 Participants |
| Myocardial Infarction History of Myocardial Infarction - No | 91 Participants | 152 Participants | 61 Participants |
| Myocardial Infarction History of Myocardial Infarction = Yes | 12 Participants | 19 Participants | 7 Participants |
| Region of Enrollment Japan | 103 participants | 171 participants | 68 participants |
| Rutherford Category Category 0 - Asymptomatic | 0 Participants | 0 Participants | 0 Participants |
| Rutherford Category Category 1 - Mild Claudication | 0 Participants | 0 Participants | 0 Participants |
| Rutherford Category Category 2 - Moderate Claudication | 45 Participants | 52 Participants | 7 Participants |
| Rutherford Category Category 3 - Severe Claudication | 55 Participants | 99 Participants | 44 Participants |
| Rutherford Category Category 4 - Ischemic Rest Pain | 1 Participants | 8 Participants | 7 Participants |
| Rutherford Category Category 5 - Minor Tissue Loss | 2 Participants | 12 Participants | 10 Participants |
| Rutherford Category Category 6- Major Tissue Loss | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 35 Participants | 17 Participants |
| Sex: Female, Male Male | 85 Participants | 136 Participants | 51 Participants |
| Smoking History Current Smoker | 29 Participants | 52 Participants | 23 Participants |
| Smoking History Not a Current Smoker | 74 Participants | 119 Participants | 45 Participants |
| Study Limb Left | 47 Participants | 83 Participants | 36 Participants |
| Study Limb Right | 56 Participants | 88 Participants | 32 Participants |
| Weight | 59.2 kilograms STANDARD_DEVIATION 10.03 | 59.2 kilograms STANDARD_DEVIATION 10.03 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 41 / 103 |
| serious Total, serious adverse events | 47 / 103 |
Outcome results
Primary
Duration of Stay
Duration (in days) of post-procedure hospital stay
Time frame: Up to discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GP1101 | Duration of Stay | 2.0 Days |
| Retrospective Surgical Bypass Outcomes | Duration of Stay | 12.5 Days |
Comparison: Hypothesis is that the post-procedure hospital stay duration for GP1101 is superior to the post-procedure hospital stay for the retrospective surgical bypass group.p-value: <0.0001Wilcoxon (Mann-Whitney)
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP1101 | Primary Assisted Patency | 91 Participants |
Comparison: A literature-based Surgical Bypass Efficacy Goal of 65% was compared to the percentage of subjects maintaining primary assisted patency at 12 months. A one-sided z-test using a Type I error of 5% was performed to test the hypotheses that the 12-month primary assisted patency probability of GP1101 is superior to the SBEG of 65%.p-value: <0.0001z-test
Primary
Rate of Avoidance of General Anesthesia
Percentage of study subjects avoiding general anesthesia
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP1101 | Rate of Avoidance of General Anesthesia | 103 Participants |
| Retrospective Surgical Bypass Outcomes | Rate of Avoidance of General Anesthesia | 17 Participants |
Comparison: The hypothesis is that the rate of avoidance of general anesthesia for GP1101 is superior to the rate of avoidance of general anesthesis for the retrospective surgical bypass group.p-value: <0.000195% CI: [96.5, 100]Fisher Exact
Secondary
Avoidance of Target Lesion Revascularization
Time frame: 24 months
Secondary
Avoidance of Target Lesion Revascularization
Time frame: 1 month
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Avoidance of Target Lesion Revascularization | 100.0 Probability of having an event |
Secondary
Avoidance of Target Lesion Revascularization
Time frame: 3 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Avoidance of Target Lesion Revascularization | 99.0 Probability of having an event |
Secondary
Avoidance of Target Lesion Revascularization
Time frame: 6 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Avoidance of Target Lesion Revascularization | 95.1 Probability of having an event |
Secondary
Avoidance of Target Lesion Revascularization
Time frame: 12 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Avoidance of Target Lesion Revascularization | 93.1 Probability of having an event |
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)
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Change in Ankle-Brachial Index From Baseline | 0.94 ABI | Standard Deviation 0.171 |
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)
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Change in Ankle-Brachial Index From Baseline | 0.95 ABI | Standard Deviation 0.137 |
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)
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Change in Ankle-Brachial Index From Baseline | 0.97 ABI | Standard Deviation 0.137 |
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),
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Change in Ankle-Brachial Index From Baseline | 0.98 ABI | Standard Deviation 0.118 |
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)
Time frame: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented
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.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP1101 | Clinical Success | 100 Participants |
95% CI: [91.7, 99.4]
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.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP1101 | Clinical Success | 98 Participants |
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP1101 | Clinical Success | 97 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP1101 | Clinical Success | 90 Participants |
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.
Time frame: 24 months
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.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP1101 | Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb) | 103 Participants |
95% CI: [96.5, 100]
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
Time frame: 12 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Percent of Participants Not Experiencing an Adverse Event | 90.9 percent of participants |
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
Time frame: 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
Time frame: 48 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 at 12 months.
Time frame: 3 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Percent of Participants Not Experiencing an Adverse Event | 97.1 Percent of participants |
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
Time frame: 1 month
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Percent of Participants Not Experiencing an Adverse Event | 97.1 percent of participants |
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
Time frame: 6 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Percent of Participants Not Experiencing an Adverse Event | 95.1 percent of participants |
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
Time frame: 24 months
Secondary
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 3 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Primary Patency | 97.1 Probability of having an event |
Secondary
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 1 month
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Primary Patency | 99.0 Probability of having an event |
Secondary
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 24 months
Secondary
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 12 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Primary Patency | 92.1 Probability of having an event |
Secondary
Primary Patency
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Time frame: 6 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Primary Patency | 92.1 Probability of having an event |
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
Time frame: 60 months
Secondary
Rate of Avoidance of Blood Transfusion
Time frame: Post-Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP1101 | Rate of Avoidance of Blood Transfusion | 103 Participants |
95% CI: [96.5, 100]
Secondary
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 24 months
Secondary
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 12 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Rate of Avoidance of Stent Fracture | 100.0 Probability of having an event |
Secondary
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 6 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Rate of Avoidance of Stent Fracture | 100.0 Probability of having an event |
Secondary
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 3 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Rate of Avoidance of Stent Fracture | 100.0 Probability of having an event |
Secondary
Rate of Avoidance of Stent Fracture
X-ray for stent fracture evaluated by Core Lab
Time frame: 1 month
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Rate of Avoidance of Stent Fracture | 100.0 Probability of having an event |
Secondary
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 24 months
Secondary
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 12 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Secondary Patency | 98.0 Probability of having an event |
Secondary
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 6 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Secondary Patency | 98.0 Probability of having an event |
Secondary
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 3 months
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Secondary Patency | 98.0 Probability of having an event |
Secondary
Secondary Patency
No bypass surgery and no occlusion at the target site
Time frame: 1 month
Population: Kaplan-Meier estimate done at end of follow-up visit window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP1101 | Secondary Patency | 99.0 Probability of having an event |
Secondary
Technical Success
Placement of GP1101 with residual stenosis of less than 30%
Time frame: Post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GP1101 | Technical Success | 102 Participants |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Vascular Quality of Life Questionnaire - VascuQOL | 5.3 units on a scale | Standard Deviation 1.26 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Vascular Quality of Life Questionnaire - VascuQOL | 5.3 units on a scale | Standard Deviation 1.23 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Vascular Quality of Life Questionnaire - VascuQOL | 5.1 units on a scale | Standard Deviation 1.3 |
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.
Time frame: 24 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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Vascular Quality of Life Questionnaire - VascuQOL | 5.5 units on a scale | Standard Deviation 1.09 |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Walking Impairment Questionnaire-WIQ | 63.9 units on a scale | Standard Deviation 34 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Walking Impairment Questionnaire-WIQ | 67.0 units on a scale | Standard Deviation 34.1 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Walking Impairment Questionnaire-WIQ | 64.0 units on a scale | Standard Deviation 34.5 |
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.
Time frame: 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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GP1101 | Walking Impairment Questionnaire-WIQ | 66.9 units on a scale | Standard Deviation 34.2 |