Peripheral Artery Disease
Conditions
Keywords
peripheral artery disease, percutaneous transluminal angioplasty, stent, balloon/stent, superficial femoral artery
Brief summary
The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal (balloon) angioplasty and stent placement for the treatment of peripheral artery disease (PAD).
Detailed description
This is an open-label dose escalation safety study of PVS-10200 in 30 subjects with peripheral artery disease (PAD) requiring balloon angioplasty and stent placement in the superficial femoral artery (SFA). The study will be completed sequentially in two dose cohorts of 10 subjects (low dose group, Cohort A) and 20 subjects (high dose group, Cohort B). A Data Safety Monitoring Board (DSMB) will conduct regular safety reviews. Each subject will receive one treatment of PVS-10200 delivered by ultrasound guided injection to the perivascular region (external to the vessel) of the stented target lesion. The treatment will be administered within 24 hours after balloon angioplasty/stent placement.
Interventions
BIOLOGICALPVS-10200
PVS-10200 is composed of allogeneic human aortic endothelial cells cultured in a gelatin matrix.
Sponsors
Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has signed the informed consent document and patient information leaflet. 2. Male and female subject ≥ 18 years of age at the time of consent. 3. If female, the subject is (a) at least 1 year post-menopausal, or (b) surgically sterile, or (c) of child-bearing potential, with a negative serum pregnancy test result prior to study enrollment, who agrees to use adequate contraception for 6 months. Adequate contraception is defined as abstinence or a reliable method of birth control (e.g., a hormonal contraceptive, intra-uterine device, implantable or injectable contraceptives (Norplant® or Depo-Provera®), diaphragm, or condom with spermicide). 4. Subject has symptomatic peripheral arterial disease involving the superficial femoral artery, defined as Fontaine Class IIb, III and IV. 5. Meets anatomic requirements based on biplane digital subtraction angiography performed at the time of intervention including: * Stenosis of ≥ 50% or occlusion of the superficial femoral artery, and * Target lesion length of ≤ 150 mm, and * At least one patent (\< 50 % stenosis) tibioperoneal runoff vessel 6. Target lesion is 7-15 cm in length. 7. Subject is expected to stay in the same geographic area for at least 48 weeks. 8. In the opinion of the investigator, the subject is able to understand and is willing to complete the study requirements. 9. Subject is receiving a therapeutic dose of statin therapy (starting minimum of 7 days prior to intervention) and continuing for a minimum of 4 weeks post-intervention.
Exclusion criteria
1. Subject has acute limb ischemia. 2. Subject has had prior revascularization of the target lesion. 3. Subject has untreated inflow disease of the ipsilateral pelvic arteries (\> 50% stenosis or occlusion). 4. The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s). 5. Subject has an unresolved thrombus within the target vessel. 6. Additional percutaneous interventional procedures (cardiac/peripheral) are planned ≤ 30 days following the study procedure. 7. Subject has suffered a hemorrhagic stroke ≤ 6 mo prior to the study procedure. 8. Subject has a history of bleeding diatheses or coagulopathy. 9. Subject is diagnosed with septicemia at the time of the study procedure. 10. Subject is known to be seropositive for HIV. 11. Subject has some other medical illness that may cause the subject to be non-compliant with the protocol. 12. Subject has a known allergy to bovine or porcine products (i.e., heparin). 13. Subject has a known allergy to collagen/gelatin products. 14. Subject has had a severe reaction to contrast media. 15. Subject has a known allergy or intolerance to anti-platelet medication (e.g., acetylsalicylic acid or clopidogrel) or statin therapy. 16. Subject has a history of IV drug use within 6 months prior to screening. 17. Subject has a documented diagnosis of cancer within 2 years (24 months) prior to screening. 18. Subject is a female who is pregnant, breast-feeding, or plans to become pregnant during the study. 19. Subject is currently participating in another investigational drug, biologic or device trial, plans to participate in another investigational drug, biologic or device study during participation in this study, or has completed participation in another investigational drug, biologic or device trial within the last 30 days. Note: Subjects involved in extended follow-up trials for products that are currently commercially available and used as approved are not considered to be participating investigational trials. 20. Subject is a staff member of any of the participating institutions or relative of a staff member.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Adverse Events (MAEs) | within 4 weeks after study procedure | Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Events | Up to 48 weeks from study procedure | — |
| Incidence of Adverse Events, Laboratory Abnormalities | Up to 48 weeks from study procedure | — |
| Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | within 4 weeks from study procedure | Primary patency was defined as duplex ultrasound peak systolic velocity \[PSV\] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject. |
| Rate of Binary In-stent Restenosis | within 4 weeks from study procedure | Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity \[PSV\] ratio ≤2.4) and Yes being 50-99% (PSV ratio \>2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject. |
| Incidence of Major Adverse Events (MAEs) | within 24 and 48 weeks from study procedure | Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events |
| Resting Ankle-brachial Index | within 4, 24 and 48 weeks from study procedure | ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. This test is used to predict the severity of PAD. |
| Changes in Physical Exam | within 4, 24 and 48 weeks from baseline | Changes in physical examination were compared to baseline: numbers of subjects presenting any new finding or worsening of abnormal findings compared to the screening examination are reported |
| The Fontaine Class of Peripheral Artery Disease | change from baseline to 4 weeks | CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene |
| Number of Patients Requiring Reintervention of Target Lesion / Target Vessel | up to 48 Weeks from study procedure | Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel |
Countries
France
Participant flow
Recruitment details
The study period was from 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit). A total of 30 subjects were screened for study eligibility, of whom a total of 21 subjects were registered (i.e., enrolled) and treated with PVS-10200. The study was conducted at 3 study centers in France
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Low dose PVS-10200 (6×10\^5 cells/cm lesion) | 11 |
| Cohort B High dose PVS-10200 (15×10\^5 cells/cm lesion) | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort B | Total | Cohort A |
|---|---|---|---|
| Age, Continuous | 70.7 Years STANDARD_DEVIATION 7.67 | 66.0 Years STANDARD_DEVIATION 9.96 | 61.6 Years STANDARD_DEVIATION 10.11 |
| Fontaine Classification STAGE IIB-MODERATE TO SEVERE CLAUDICATION(<200M) | 6 Participants | 16 Participants | 10 Participants |
| Fontaine Classification STAGE IV - ULCERATION OR GANGRENE | 4 Participants | 5 Participants | 1 Participants |
| Region of Enrollment France | 10 Participants | 21 Participants | 11 Participants |
| Resting Ankle Brachial Index, Leg with Target Lesion | 0.851 ratio STANDARD_DEVIATION 0.258 | 0.902 ratio STANDARD_DEVIATION 0.217 | 0.954 ratio STANDARD_DEVIATION 0.164 |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 15 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 10 / 10 |
| serious Total, serious adverse events | 7 / 11 | 7 / 10 |
Outcome results
Primary
Incidence of Major Adverse Events (MAEs)
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
Time frame: within 4 weeks after study procedure
Population: Intention-to-Treat Population Analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Incidence of Major Adverse Events (MAEs) | 0 participants |
| Cohort B | Incidence of Major Adverse Events (MAEs) | 0 participants |
Secondary
Changes in Physical Exam
Changes in physical examination were compared to baseline: numbers of subjects presenting any new finding or worsening of abnormal findings compared to the screening examination are reported
Time frame: within 4, 24 and 48 weeks from baseline
Population: Safety Population Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Changes in Physical Exam | Week 4 | 0 participants |
| Cohort A | Changes in Physical Exam | Week 24 | 5 participants |
| Cohort A | Changes in Physical Exam | Week 48 | 3 participants |
| Cohort B | Changes in Physical Exam | Week 4 | 3 participants |
| Cohort B | Changes in Physical Exam | Week 24 | 1 participants |
| Cohort B | Changes in Physical Exam | Week 48 | 3 participants |
Secondary
Incidence of Adverse Events, Laboratory Abnormalities
Time frame: Up to 48 weeks from study procedure
Population: Safety Population Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Incidence of Adverse Events, Laboratory Abnormalities | Treatment Emergent Adverse Events | 11 participants |
| Cohort A | Incidence of Adverse Events, Laboratory Abnormalities | Clinically Significant Laboratory | 1 participants |
| Cohort B | Incidence of Adverse Events, Laboratory Abnormalities | Treatment Emergent Adverse Events | 10 participants |
| Cohort B | Incidence of Adverse Events, Laboratory Abnormalities | Clinically Significant Laboratory | 5 participants |
Secondary
Incidence of Major Adverse Events (MAEs)
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
Time frame: within 24 and 48 weeks from study procedure
Population: Intention-to-Treat Population Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Incidence of Major Adverse Events (MAEs) | Week 24 | 0 participants |
| Cohort A | Incidence of Major Adverse Events (MAEs) | Week 48 | 0 participants |
| Cohort B | Incidence of Major Adverse Events (MAEs) | Week 24 | 0 participants |
| Cohort B | Incidence of Major Adverse Events (MAEs) | Week 48 | 1 participants |
Secondary
Incidence of Serious Adverse Events
Time frame: Up to 48 weeks from study procedure
Population: Intention-to-Treat Population Analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Incidence of Serious Adverse Events | 7 participants |
| Cohort B | Incidence of Serious Adverse Events | 7 participants |
Secondary
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
Primary patency was defined as duplex ultrasound peak systolic velocity \[PSV\] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Time frame: within 4 weeks from study procedure
Population: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | YES | 9 participants |
| Cohort A | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | NO | 0 participants |
| Cohort B | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | NO | 0 participants |
| Cohort B | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | YES | 9 participants |
Secondary
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
Primary patency was defined as duplex ultrasound peak systolic velocity \[PSV\] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Time frame: within 24 weeks from study procedure
Population: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | NO | 4 participants |
| Cohort A | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | YES | 5 participants |
| Cohort B | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | NO | 4 participants |
| Cohort B | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | YES | 4 participants |
Secondary
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
Primary patency was defined as duplex ultrasound peak systolic velocity \[PSV\] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Time frame: within 48 weeks from study procedure
Population: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | NO | 3 participants |
| Cohort A | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | YES | 4 participants |
| Cohort B | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | NO | 3 participants |
| Cohort B | Maintenance of Primary Patency of Superficial Femoral Artery (SFA) | YES | 3 participants |
Secondary
Number of Patients Requiring Reintervention of Target Lesion / Target Vessel
Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel
Time frame: up to 48 Weeks from study procedure
Population: Intention-to-Treat Population Analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Number of Patients Requiring Reintervention of Target Lesion / Target Vessel | 4 participants |
| Cohort B | Number of Patients Requiring Reintervention of Target Lesion / Target Vessel | 2 participants |
Secondary
Rate of Binary In-stent Restenosis
Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity \[PSV\] ratio ≤2.4) and Yes being 50-99% (PSV ratio \>2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Time frame: within 24 weeks from study procedure
Population: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Rate of Binary In-stent Restenosis | NO | 9 participants |
| Cohort A | Rate of Binary In-stent Restenosis | YES | 0 participants |
| Cohort B | Rate of Binary In-stent Restenosis | NO | 8 participants |
| Cohort B | Rate of Binary In-stent Restenosis | YES | 0 participants |
Secondary
Rate of Binary In-stent Restenosis
Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity \[PSV\] ratio ≤2.4) and Yes being 50-99% (PSV ratio \>2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Time frame: within 4 weeks from study procedure
Population: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Rate of Binary In-stent Restenosis | NO | 9 participants |
| Cohort A | Rate of Binary In-stent Restenosis | YES | 0 participants |
| Cohort B | Rate of Binary In-stent Restenosis | NO | 9 participants |
| Cohort B | Rate of Binary In-stent Restenosis | YES | 0 participants |
Secondary
Rate of Binary In-stent Restenosis
Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity \[PSV\] ratio ≤2.4) and Yes being 50-99% (PSV ratio \>2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Time frame: within 48 weeks from study procedure
Population: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | Rate of Binary In-stent Restenosis | NO | 8 participants |
| Cohort A | Rate of Binary In-stent Restenosis | YES | 0 participants |
| Cohort B | Rate of Binary In-stent Restenosis | NO | 7 participants |
| Cohort B | Rate of Binary In-stent Restenosis | YES | 0 participants |
Secondary
Resting Ankle-brachial Index
ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. This test is used to predict the severity of PAD.
Time frame: within 4, 24 and 48 weeks from study procedure
Population: Intention-to-Treat Population Analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Resting Ankle-brachial Index | Week 4 | 0.984 ratio | Standard Deviation 0.128 |
| Cohort A | Resting Ankle-brachial Index | Week 24 | 0.948 ratio | Standard Deviation 0.172 |
| Cohort A | Resting Ankle-brachial Index | Week 48 | 0.931 ratio | Standard Deviation 0.193 |
| Cohort B | Resting Ankle-brachial Index | Week 4 | 0.887 ratio | Standard Deviation 0.237 |
| Cohort B | Resting Ankle-brachial Index | Week 24 | 0.842 ratio | Standard Deviation 0.204 |
| Cohort B | Resting Ankle-brachial Index | Week 48 | 0.857 ratio | Standard Deviation 0.226 |
Secondary
The Fontaine Class of Peripheral Artery Disease
CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene
Time frame: change from baseline to 4 weeks
Population: Intention-to-Treat Population Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE I (Week 4) | 9 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIA (Week 4) | 1 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE I (Week 4) | 1 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE IV (Week 4) | 0 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE IV (Week 4) | 4 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE I (Week 4) | 5 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE I (Week 4) | 0 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIA (Week 4) | 1 participants |
Secondary
The Fontaine Class of Peripheral Artery Disease
CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene
Time frame: change from baseline to 24 weeks
Population: Intention-to-Treat Population Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE I (Week 24) | 4 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIA (Week 24) | 4 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIB (Week 24) | 2 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE I (Week 24) | 0 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE IV (Week 24) | 0 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | Missing | 1 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE IV (Week 24) | 2 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE I (Week 24) | 3 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE I (Week 24) | 1 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIA (Week 24) | 1 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | Missing | 2 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIB (Week 24) | 1 participants |
Secondary
The Fontaine Class of Peripheral Artery Disease
CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene
Time frame: change from baseline to 48 weeks
Population: Intention-to-Treat Population Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A | The Fontaine Class of Peripheral Artery Disease | Missing | 1 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE I (Week 48) | 6 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIA (Week 48) | 1 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIB (Week 48) | 3 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE I (Week 48) | 0 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE IIB (Week 48) | 0 participants |
| Cohort A | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE IV (Week 48) | 0 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | Missing | 1 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE I (Week 48) | 1 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE I (Week 48) | 4 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE IV (Week 48) | 1 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIA (Week 48) | 1 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IV (Baseline) to STAGE IIB (Week 48) | 1 participants |
| Cohort B | The Fontaine Class of Peripheral Artery Disease | STAGE IIB (Baseline) to STAGE IIB (Week 48) | 1 participants |