Atherosclerosis of Native Arteries of the Extremities, Unspecified
Conditions
Keywords
Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, Stenting
Brief summary
The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.
Detailed description
Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion. The SuperNOVA clinical study is a prospective, single arm, controlled, multicenter, global study. Approximately 50 centers located in the United States, Europe, Canada and/or Australia are expected to participate in recruiting patients needing treatment of lesions in their femoropopliteal arteries. A maximum of 300 subjects will be enrolled to ensure that a minimum of 296 stented segments are treated with the Innova Stent System.
Interventions
DEVICEStent implantation
Stent implantation during the index procedure.
Sponsors
Boston Scientific Corporation
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. Subjects age 18 and older 2. Chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4 3. Stenotic, restenotic (from angioplasty only) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery: 1. Degree of stenosis \>/=70% by visual angiographic assessment 2. Vessel diameter \>/= 4 and \</= 7mm 3. Total lesion length (or series of lesions) \>/=30mm and \</= 190 mm (note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent) 4. If lesion is restenotic, PTA treatment must be \>3 months prior to stent placement 5. Target lesion located at least three centimeters above the inferior edge of the femur 4. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\<50% stenosis) to the ankle or foot 5. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits
Exclusion criteria
1. Previous stent placement in the target vessel 2. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease 3. Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the target SFA/PPA in the past 3 months 4. Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the index procedure 5. History of major amputation in the same limb as the target lesion 6. Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical study, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical study 7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated. 8. Intolerance to antiplatelet, anticoagulant, or thrombolytic medications 9. Platelet count \<150,000 mm3 or \>600,000 mm3 10. Concomitant renal failure with a serum creatinine \>2.0 mg/dL 11. Receiving dialysis or immunosuppressant therapy 12. Pregnancy 13. Current participation in another investigational drug or device clinical study 14. Known allergy to Nitinol 15. Septicemia at the time of the index procedure 16. Presence of other hemodynamically significant outflow lesions requiring intervention within 30 days of the index procedure 17. Target lesion is within or near an aneurysm 18. Acute ischemia and/or acute thrombosis of the SFA/PPA 19. Persistent, intraluminal thrombus of the proposed target lesion post- thrombolytic therapy 20. Perforated vessel as evidenced by extravasation of contrast media 21. Heavily calcified lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint and Components | 1 month for death, 12 months for target limb major amputation , and target lesion revascularization | The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months |
| Co-Primary Efficacy Endpoints | 12 months | The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure. * The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm). * The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoint and Components | 1 month | The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assisted Primary Patency | 12 months | Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis. |
| Stent Fracture Rate | 12 months | Vascular InterVentional Advances (VIVA) definitions: Grade 0: No strut fractures Grade I: single strut fracture Grade II: multiple strut fractures Grade III: stent fracture(s) with preserved alignment of the components Grade IV: stent fracture(s) with mal-alignment of the components Grade V: stent fracture(s) in a trans-axial spiral configuration |
| Rutherford Classification | 12 months | Class 0: Asymptomatic Class 1: Mild claudication Class 2: Moderate claudication Class 3: Severe claudication Class 4: Ischemic rest pain Class 5: Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema Class 6: Major tissue loss - extending above metatarsal (MT) level Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR. Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR. Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure |
| Walking Improvement (Distance) Assessed by 6 Minute Hall Walk | 12 months | Assessment of walking improvement (distance) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes. |
| Walking Improvement Assessed by the Walking Impairment Questionnaire | 12 months | The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. |
| Walking Improvement (Time) Assessed by 6 Minute Hall Walk | 12 months | Assessment of walking improvement (time) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes. |
| Quality of Life | 12 months | Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning. |
| Rate of Hemodynamic Improvement | 12 months | The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm. Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR. Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR. |
| Technical and Procedural Success | Up to 24 hours after the procedure | * Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% * Procedural success: technical success with no MAEs within 24 hours of the procedure |
| Primary Patency | 12 months | Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion. |
Countries
Austria, Belgium, Canada, Germany, Japan, United Kingdom, United States
Participant flow
Recruitment details
A total of 299 subjects were enrolled and treated with the Innova™ Self-Expanding Stent System in this prospective, single-arm, non-randomized clinical study at 49 investigative centers in The Unites States, Canada, Japan and Europe, from 1 April 2011 to 28 June 2013 (with a temporary enrollment suspension from 13 May 2011 to 25 April 2012)
Participants by arm
| Arm | Count |
|---|---|
| Innova Stent Stent implantation into SFA/PPA | 299 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 8 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Innova Stent |
|---|---|
| Age, Continuous | 67.4 Years STANDARD_DEVIATION 9.7 |
| Baseline Lesion Characteristics: Diameter Stenosis | 91.7 percentage occluded STANDARD_DEVIATION 9.2 |
| Baseline Lesion Characteristics: Presence of Calcification Moderate | 103 lesions |
| Baseline Lesion Characteristics: Presence of Calcification None/Mild | 88 lesions |
| Baseline Lesion Characteristics: Presence of Calcification Not Available | 2 lesions |
| Baseline Lesion Characteristics: Presence of Calcification Severe | 106 lesions |
| Baseline Lesion Characteristics: Reference Vessel Diameter | 5.6 millimeters STANDARD_DEVIATION 0.7 |
| Baseline Lesion Characteristics: Target Lesion Length | 90.8 millimeters STANDARD_DEVIATION 44.4 |
| Baseline Lesion Characteristics: Treated Limb Left leg | 161 lesions |
| Baseline Lesion Characteristics: Treated Limb Right leg | 138 lesions |
| Cardiac History History of Congestive Heart Failure | 25 participants |
| Cardiac History History of Coronary Artery Bypass Graft Surgery | 54 participants |
| Cardiac History History of Coronary Artery Disease | 130 participants |
| Cardiac History History of Myocardial Infarction (MI) | 74 participants |
| Cardiac History History of Percutaneous Coronary Intervention | 85 participants |
| Cardiac History No Angina | 245 participants |
| Cardiac History Stable Angina | 44 participants |
| Cardiac History Unstable Angina | 1 participants |
| General Medical History Current Diabetes Mellitus | 121 participants |
| General Medical History History of Chronic Obstructive Pulmonary Disease | 25 participants |
| General Medical History History of Hyperlipidemia requiring medication | 224 participants |
| General Medical History History of Hypertension requiring medication | 239 participants |
| General Medical History History of Smoking | 251 participants |
| General Medical History Medically-Treated Diabetes | 105 participants |
| Neurological/Renal History History of Cerebrovascular Accident | 24 participants |
| Neurological/Renal History History of Renal Insufficiency | 31 participants |
| Neurological/Renal History History of Renal Percutaneous Intervention | 4 participants |
| Neurological/Renal History History of Transient Ischemic Attacks | 21 participants |
| Peripheral Vascular History History of Claudication | 281 participants |
| Peripheral Vascular History History of Other Peripheral Interventions | 125 participants |
| Peripheral Vascular History History of Peripheral Vascular Surgery | 27 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants |
| Race/Ethnicity, Customized Asian (Japanese) | 42 participants |
| Race/Ethnicity, Customized Black, or African heritage | 13 participants |
| Race/Ethnicity, Customized Caucasian | 238 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 participants |
| Region of Enrollment Austria | 6 participants |
| Region of Enrollment Belgium | 52 participants |
| Region of Enrollment Canada | 31 participants |
| Region of Enrollment Germany | 44 participants |
| Region of Enrollment Japan | 42 participants |
| Region of Enrollment United Kingdom | 7 participants |
| Region of Enrollment United States | 117 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 222 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 116 / 266 |
| serious Total, serious adverse events | 143 / 266 |
Outcome results
Primary
Co-Primary Efficacy Endpoints
The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure. * The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm). * The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm).
Time frame: 12 months
Population: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Co-Primary Efficacy Endpoints were available for 268 subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Innova Stent | Co-Primary Efficacy Endpoints | 69.7 percentage of participants |
| Innova Stent Entire Matrix (20-200 mm) | Co-Primary Efficacy Endpoints | 66.8 percentage of participants |
Primary
Primary Safety Endpoint and Components
The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months
Time frame: 1 month for death, 12 months for target limb major amputation , and target lesion revascularization
Population: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Safety Endpoint were available for 268 subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Innova Stent | Primary Safety Endpoint and Components | 12-Month MAE-Free Rate | 85.8 percentage of participants |
| Innova Stent | Primary Safety Endpoint and Components | 12-Month MAE (Composite Endpoint) | 14.2 percentage of participants |
| Innova Stent | Primary Safety Endpoint and Components | All Causes of Deaths at 1 Month | 0.0 percentage of participants |
| Innova Stent | Primary Safety Endpoint and Components | Target Limb Major Amputations | 0.4 percentage of participants |
| Innova Stent | Primary Safety Endpoint and Components | Target Lesion Revascularization | 14.2 percentage of participants |
Secondary
Secondary Safety Endpoint and Components
The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month
Time frame: 1 month
Population: From the 299 enrolled subjects, data for the Secondary Safety Endpoint was available for 297 subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Innova Stent | Secondary Safety Endpoint and Components | 1-Month MAE-Free Rate | 99.7 percentage of participants |
| Innova Stent | Secondary Safety Endpoint and Components | 1-Month MAE (Composite Endpoint) | 0.3 percentage of participants |
| Innova Stent | Secondary Safety Endpoint and Components | All Causes of Deaths | 0.0 percentage of participants |
| Innova Stent | Secondary Safety Endpoint and Components | Target Limb Major Amputation | 0.0 percentage of participants |
| Innova Stent | Secondary Safety Endpoint and Components | Target Lesion Revascularization | 0.3 percentage of participants |
Other Pre-specified
Assisted Primary Patency
Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.
Time frame: 12 months
Population: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Assisted Primary Patency Analysis was available for 256 subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Innova Stent | Assisted Primary Patency | 83.6 percentage of lesions |
Other Pre-specified
Primary Patency
Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.
Time frame: 12 months
Population: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Patency Analysis was available for 268 subjects/lesions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Innova Stent | Primary Patency | 66.8 percentage of lesions |
Other Pre-specified
Quality of Life
Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.
Time frame: 12 months
Population: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Quality of Life Analysis were available for 265 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Innova Stent | Quality of Life | Physical Functioning | 41.17 units on a scale | Standard Deviation 11.38 |
| Innova Stent | Quality of Life | Physical Functioning Change from Baseline | 6.53 units on a scale | Standard Deviation 10.29 |
| Innova Stent | Quality of Life | Role Physical | 43.39 units on a scale | Standard Deviation 11.48 |
| Innova Stent | Quality of Life | Role Physical Change from Baseline | 5.14 units on a scale | Standard Deviation 11.9 |
| Innova Stent | Quality of Life | Role Emotional | 45.45 units on a scale | Standard Deviation 13.22 |
| Innova Stent | Quality of Life | Role Emotional Change from Baseline | 3.49 units on a scale | Standard Deviation 14.61 |
| Innova Stent | Quality of Life | Social Functioning | 48.12 units on a scale | Standard Deviation 10.55 |
| Innova Stent | Quality of Life | Social Functioning Change from Baseline | 2.66 units on a scale | Standard Deviation 13.26 |
| Innova Stent | Quality of Life | Bodily Pain | 46.52 units on a scale | Standard Deviation 11.33 |
| Innova Stent | Quality of Life | Bodily Pain Change from Baseline | 7.28 units on a scale | Standard Deviation 12.19 |
| Innova Stent | Quality of Life | Mental Health | 50.19 units on a scale | Standard Deviation 10.46 |
| Innova Stent | Quality of Life | Mental Health Change from Baseline | 2.33 units on a scale | Standard Deviation 11.21 |
| Innova Stent | Quality of Life | Vitality | 50.57 units on a scale | Standard Deviation 10.98 |
| Innova Stent | Quality of Life | Vitality Change from Baseline | 3.10 units on a scale | Standard Deviation 10.68 |
| Innova Stent | Quality of Life | General Health Perceptions | 44.65 units on a scale | Standard Deviation 9.9 |
| Innova Stent | Quality of Life | General Health Perceptions Change from Baseline | 1.32 units on a scale | Standard Deviation 9.51 |
| Innova Stent | Quality of Life | Mental Component Score | 51.14 units on a scale | Standard Deviation 10.71 |
| Innova Stent | Quality of Life | Mental Component Score Change from Baseline | 0.86 units on a scale | Standard Deviation 11.69 |
| Innova Stent | Quality of Life | Physical Component Score | 42.66 units on a scale | Standard Deviation 10.3 |
| Innova Stent | Quality of Life | Physical Component Score Change from Baseline | 6.31 units on a scale | Standard Deviation 10.23 |
Other Pre-specified
Rate of Hemodynamic Improvement
The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm. Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR. Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR.
Time frame: 12 months
Population: 278 subjects were included in the Rate of Hemodynamic Improvement Analysis (275 subjects eligible for the 12-Month Follow-Up + 3 subjects with TLR)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Innova Stent | Rate of Hemodynamic Improvement | Hemodynamic Improvement | 59 percentage of limbs |
| Innova Stent | Rate of Hemodynamic Improvement | Hemodynamic Improvement (Including TLR) | 68.3 percentage of limbs |
Other Pre-specified
Rutherford Classification
Class 0: Asymptomatic Class 1: Mild claudication Class 2: Moderate claudication Class 3: Severe claudication Class 4: Ischemic rest pain Class 5: Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema Class 6: Major tissue loss - extending above metatarsal (MT) level Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR. Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR. Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure
Time frame: 12 months
Population: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Rutherford Classification Analysis was available for 263 subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Innova Stent | Rutherford Classification | Rutherford Class 0 | 65.8 percentage of participants |
| Innova Stent | Rutherford Classification | Rutherford Class 1 | 19.0 percentage of participants |
| Innova Stent | Rutherford Classification | Rutherford Class 2 | 8.0 percentage of participants |
| Innova Stent | Rutherford Classification | Rutherford Class 3 | 6.8 percentage of participants |
| Innova Stent | Rutherford Classification | Rutherford Class 4 | 0.0 percentage of participants |
| Innova Stent | Rutherford Classification | Rutherford Class 5 | 0.4 percentage of participants |
| Innova Stent | Rutherford Classification | Rutherford Class 6 | 0.0 percentage of participants |
| Innova Stent | Rutherford Classification | Primary Sustained Clinical Improvement | 79.5 percentage of participants |
| Innova Stent | Rutherford Classification | Secondary Sustained Clinical Improvement | 90.1 percentage of participants |
| Innova Stent | Rutherford Classification | Clinical Deterioration | 2.7 percentage of participants |
| Innova Stent | Rutherford Classification | No Change from Baseline | 7.2 percentage of participants |
Other Pre-specified
Stent Fracture Rate
Vascular InterVentional Advances (VIVA) definitions: Grade 0: No strut fractures Grade I: single strut fracture Grade II: multiple strut fractures Grade III: stent fracture(s) with preserved alignment of the components Grade IV: stent fracture(s) with mal-alignment of the components Grade V: stent fracture(s) in a trans-axial spiral configuration
Time frame: 12 months
Population: From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Stent Fracture Analysis were available for 250 subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Innova Stent | Stent Fracture Rate | Grade II | 0.76 percentage of stents |
| Innova Stent | Stent Fracture Rate | Grade III | 1.14 percentage of stents |
| Innova Stent | Stent Fracture Rate | Grade IV | 0.38 percentage of stents |
| Innova Stent | Stent Fracture Rate | Total | 2.27 percentage of stents |
Other Pre-specified
Technical and Procedural Success
* Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% * Procedural success: technical success with no MAEs within 24 hours of the procedure
Time frame: Up to 24 hours after the procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Innova Stent | Technical and Procedural Success | Technical Success | 99 percentage of participants |
| Innova Stent | Technical and Procedural Success | Procedure Success | 99 percentage of participants |
Other Pre-specified
Walking Improvement Assessed by the Walking Impairment Questionnaire
The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.
Time frame: 12 months
Population: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement assessed by the Walking Impairment Questionnaire were available for 265 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Innova Stent | Walking Improvement Assessed by the Walking Impairment Questionnaire | Walking Impairment | 73.87 units on a scale | Standard Deviation 30.98 |
| Innova Stent | Walking Improvement Assessed by the Walking Impairment Questionnaire | Change from Baseline | 34.03 units on a scale | Standard Deviation 37.22 |
Other Pre-specified
Walking Improvement (Distance) Assessed by 6 Minute Hall Walk
Assessment of walking improvement (distance) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.
Time frame: 12 months
Population: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Innova Stent | Walking Improvement (Distance) Assessed by 6 Minute Hall Walk | Baseline | 278.6 meters | Standard Deviation 119.1 |
| Innova Stent | Walking Improvement (Distance) Assessed by 6 Minute Hall Walk | 12-Months | 358.9 meters | Standard Deviation 147.2 |
Other Pre-specified
Walking Improvement (Time) Assessed by 6 Minute Hall Walk
Assessment of walking improvement (time) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.
Time frame: 12 months
Population: From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Innova Stent | Walking Improvement (Time) Assessed by 6 Minute Hall Walk | Baseline | 5.5 minutes | Standard Deviation 1.3 |
| Innova Stent | Walking Improvement (Time) Assessed by 6 Minute Hall Walk | 12-Months | 5.7 minutes | Standard Deviation 0.9 |