Peripheral Artery Disease, Peripheral Vascular Disease
Conditions
Keywords
Vascular intervention, Endovascular, Peripheral stent
Brief summary
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.
Interventions
DEVICEAstron Stents
Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery.
DEVICEPulsar Stents
Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries.
Sponsors
Biotronik, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To support the objectives of this study, the following initial inclusion criteria must be met for a subject to be enrolled and considered for the index procedure: * Age ≥ 18 years * Willingness to comply with study follow-up requirements * Candidate for PTA * Life-style limiting claudication or rest pain with an ABI ≤ 0.9 (resting or exercise). Thigh brachial index (TBI) may be used / performed if ABI is inadequate. * Written informed consent For a subject to receive an investigational stent, the following procedure-related criteria must be met: * One de novo, restenotic or occluded lesion representing a femoro-popliteal or iliac indication OR Two de novo, restenotic or occluded lesions representing one femoro-popliteal indication and one iliac indication on contralateral limbs - (i.e. one lesion per limb) * Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion * Subjects with bilateral, SFA/PPA disease (i.e. one SFA/PPA lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral SFA/PPA intervention may be performed at the time of the index procedure (prior to treatment of study lesion); however, the use of an investigational treatment is prohibited. If the contralateral SFA/PPA intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the contralateral intervention is prohibited. * Subjects with bilateral, iliac disease (i.e. one iliac lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral iliac intervention may be performed at the time of the index procedure; however, the use of an investigational treatment is prohibited. If the contralateral iliac intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the subsequent contralateral intervention is also prohibited. * Femoro-popliteal lesions must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space) * Iliac lesions must be located only in either the common or external iliac artery * Lesions must be treatable with a maximum of two stents * Angiographic evidence of ≥ 70% stenosis or occlusion (operator visual assessment) * Lesion length ≤ 190 mm (if de novo or restenotic) or ≤ 100 mm (if occluded) * Target vessel reference diameter: 2.5 to 6 mm (SFA/PPA) or 6 to 9 mm (iliac arteries) by visual estimate * Angiographic evidence of patent SFA and PPA (iliac indication) and angiographic evidence of at least one distal vessel runoff to the foot (both femoro-popliteal and iliac indications). Patent is defined as \< 50% stenosis. * For SFA/PPA intervention, a significant stenosis (\> 70%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) just prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.
Exclusion criteria
To support the objectives of this study, the following initial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Endpoint for the Pulsar Stent: Primary Patency | 12 months | The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of \> 50% stenosis. |
| Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events | 30 days | The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation. |
| Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE) | 12 months | The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%. |
| Percentage of Participants With Primary Safety Endpoint (Post Market Analysis) | 36 Months | Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate | 12 months | Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of \> 50% stenosis. |
| Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency | 12 months | Evaluate the primary assisted patency rate (freedom from remote Target Vessel Revascularization \[TVR\]) for the Astron and Pulsar stent at 12 months post-index procedure. |
| Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency | 12 months | Evaluate the secondary patency rate (freedom from bypass and amputation of the target limb) for the Astron and Pulsar stent at 12 months post-index procedure. |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement | 12 months | The purpose of this endpoint is to compare the ABI measurements between baseline and 12 months post-index procedure. ABI is the ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm. |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test | 12 months | The purpose of this endpoint is to compare the distance walked during the 6-minute walk test between baseline and 12 months post-index procedure. |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score | 12 months | The purpose of this endpoint is to compare Walking Impairment Questionnaire (WIQ) Peripheral Arterial Disease (PAD) specific score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score | 12 months | The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Distance score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score | 12 months | The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Speed score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 |
| Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score | 12 months | The purpose of this endpoint is to compare Walking Impairment Questionnaire Stair Climbing score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621 |
| Acute Procedural Success for Astron and Pulsar Stent | 30 days | Evaluate the acute procedural success of the Astron and Pulsar stent. Acute procedural success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs before hospital discharge. |
| Clinical Success | 30 days | Evaluate the 30-day clinical success of the procedure. The 30-day clinical success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs within 30 days of the index procedure. |
| Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates | 12 month | Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group. Please see the Serious Adverse Events and Other Adverse Events sections for event details. |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate | 30 days | Compare the 30 day MAE rate results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months | 12 months | Compare the primary patency at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months | 12 months | Compare the primary assisted patency (freedom from remote TVR) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months | 12 months | Compare the secondary patency (freedom from bypass and amputation of the target limb) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success | Acute / Date of Procedure | Compare the acute procedure success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. |
| Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success | 30 days | Compare the 30-day clinical success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group. |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate | 12 months | Compare the MAE rate results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months | 12 months | Compare the primary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months | 12 months | Compare the stent fracture rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months | 12 months | Compare the primary assisted patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months | 12 months | Compare the secondary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success | Acute / Date of Procedure | Compare the acute procedure success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. |
| Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success | 30 days | Compare the 30-day clinical success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group. |
| Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval) | 24 Months | Evaluate the rate of freedom from target lesion revascularization (TLR) and/or index limb amputation for the Pulsar stent. |
| Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval) | 24 Months | Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent. |
| Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval). | 36 Months | Evaluate the MAE rate and the individual component rates of mortality at 30 days post-index procedure, target lesion revascularization (TLR) and index limb amputation for the Pulsar stent. |
| Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group) | 24 Months | — |
| Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group) | 36 Months | — |
| Number of Participants With Stent Fracture at 24 Months (Post Approval). | 24 Months | — |
| Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation | 30 days | Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent. |
| Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group). | 36 months | Summary of serious adverse event rates at 36 months. Refer to SAE section. |
| Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group). | 36 Months | — |
| Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate | 12 months | Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate. |
| Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate | 12 months | Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure. An independent angiographic core laboratory reviewed x-ray imaging for presence or absence of a stent fracture. Fractures were assessed with Grade I indicating a single tine fracture, Grade II indicating multiple tine fracture, Grade III indicating stent fracture(s) with preserved alignment of the components, Grade IV indicating stent fracture(s) with mal-alignment of the components, and Grade V stent fracture(s) in a trans-axial spiral configuration. Generally, fractures of Grade I are least severe, increasing in severity to Grade V. |
| Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate | 12 months | Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Astron Stent Group Subjects implanted with an Astron stent. | 161 |
| Pulsar Stent Group Subjects implanted with an Astron Pulsar or Pulsar-18 stent. | 302 |
| Total | 463 |
Baseline characteristics
| Characteristic | Astron Stent Group | Pulsar Stent Group | Total |
|---|---|---|---|
| Age, Continuous | 63.6 Years STANDARD_DEVIATION 10.1 | 67.3 Years STANDARD_DEVIATION 10.3 | NA Years |
| Distal Vessel Runoff 0 Vessel | 9 Participants | 19 Participants | NA Participants |
| Distal Vessel Runoff 1 Vessel | 32 Participants | 74 Participants | NA Participants |
| Distal Vessel Runoff 2 Vessel | 48 Participants | 93 Participants | NA Participants |
| Distal Vessel Runoff 3 Vessel | 37 Participants | 84 Participants | NA Participants |
| Distal Vessel Runoff Not Available | 35 Participants | 32 Participants | NA Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 21 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 143 Participants | 281 Participants | 424 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Lesion Calcification Moderate | 68 Participants | 91 Participants | NA Participants |
| Lesion Calcification None | 47 Participants | 82 Participants | NA Participants |
| Lesion Calcification Severe | 46 Participants | 129 Participants | NA Participants |
| Lesion Length | 35.9 mm STANDARD_DEVIATION 21.3 | 82.0 mm STANDARD_DEVIATION 46.9 | NA mm |
| Lesion Location Common iliac | 107 Participants | 0 Participants | 107 Participants |
| Lesion Location Distal SFA | 0 Participants | 99 Participants | 99 Participants |
| Lesion Location External iliac | 54 Participants | 0 Participants | 54 Participants |
| Lesion Location Mid SFA | 0 Participants | 156 Participants | 156 Participants |
| Lesion Location Ostial SFA | 0 Participants | 2 Participants | 2 Participants |
| Lesion Location Proximal popliteal | 0 Participants | 7 Participants | 7 Participants |
| Lesion Location Proximal SFA | 0 Participants | 38 Participants | 38 Participants |
| Medical History Cerebrovascular disease | 22 Participants | 48 Participants | NA Participants |
| Medical History Current smoker | 78 Participants | 122 Participants | NA Participants |
| Medical History Diabetes | 32 Participants | 123 Participants | NA Participants |
| Medical History History of congestive heart failure | 11 Participants | 27 Participants | NA Participants |
| Medical History History of coronary revasularization | 54 Participants | 110 Participants | NA Participants |
| Medical History History of ischemic heart disease | 69 Participants | 124 Participants | NA Participants |
| Medical History Hyperlipidemia | 125 Participants | 245 Participants | NA Participants |
| Medical History Hypertension | 117 Participants | 255 Participants | NA Participants |
| Medical History Never smoked or not within last 5 years | 47 Participants | 134 Participants | NA Participants |
| Medical History Renal insufficiency | 11 Participants | 17 Participants | NA Participants |
| Medical History Smoked within last 5 years | 36 Participants | 46 Participants | NA Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 22 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 152 Participants | 273 Participants | 425 Participants |
| Region of Enrollment Austria | 32 Participants | 34 Participants | NA Participants |
| Region of Enrollment Belgium | 0 Participants | 32 Participants | NA Participants |
| Region of Enrollment Canada | 38 Participants | 29 Participants | NA Participants |
| Region of Enrollment Germany | 0 Participants | 14 Participants | NA Participants |
| Region of Enrollment Switzerland | 0 Participants | 6 Participants | NA Participants |
| Region of Enrollment United States | 91 Participants | 187 Participants | NA Participants |
| Sex: Female, Male Female | 56 Participants | 97 Participants | 153 Participants |
| Sex: Female, Male Male | 105 Participants | 205 Participants | 310 Participants |
| Trans-Atlantic Inter-Society Consensus (TASC II) Type Type A | 99 Participants | 166 Participants | NA Participants |
| Trans-Atlantic Inter-Society Consensus (TASC II) Type Type B | 56 Participants | 106 Participants | NA Participants |
| Trans-Atlantic Inter-Society Consensus (TASC II) Type Type C | 6 Participants | 26 Participants | NA Participants |
| Trans-Atlantic Inter-Society Consensus (TASC II) Type Type D | 0 Participants | 3 Participants | NA Participants |
| Vessel Diameter Post-deployment Minimum Lumen Diameter (MLD) | 6.0 mm STANDARD_DEVIATION 1.2 | 4.1 mm STANDARD_DEVIATION 0.7 | NA mm |
| Vessel Diameter Pre-deployment Minimum Lumen Diameter (MLD) | 2.1 mm STANDARD_DEVIATION 1.3 | 1.0 mm STANDARD_DEVIATION 0.9 | NA mm |
| Vessel Diameter Reference vessel diameter | 7.6 mm STANDARD_DEVIATION 1.5 | 5.0 mm STANDARD_DEVIATION 0.9 | NA mm |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 161 | 27 / 302 |
| other Total, other adverse events | 33 / 161 | 179 / 302 |
| serious Total, serious adverse events | 67 / 161 | 180 / 302 |
Outcome results
Primary
Effectiveness Endpoint for the Pulsar Stent: Primary Patency
The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of \> 50% stenosis.
Time frame: 12 months
Population: Participants for whom patency could be confirmed at 12 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Effectiveness Endpoint for the Pulsar Stent: Primary Patency | 66.8 Percentage of participants |
Primary
Percentage of Participants With Primary Safety Endpoint (Post Market Analysis)
Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months.
Time frame: 36 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Percentage of Participants With Primary Safety Endpoint (Post Market Analysis) | 78.2 percentage of participants |
Primary
Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)
The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE) | 2.1 Percentage of participants |
Primary
Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events
The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.
Time frame: 30 days
Population: All participants implanted with an Astron Pulsar or Pulsar-18 stent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events | 99.7 Percentage of participants |
Secondary
Acute Procedural Success for Astron and Pulsar Stent
Evaluate the acute procedural success of the Astron and Pulsar stent. Acute procedural success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs before hospital discharge.
Time frame: 30 days
Population: Includes all participants who underwent implantation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Acute Procedural Success for Astron and Pulsar Stent | 95.0 Percentage of participants |
| Pulsar Stent Group | Acute Procedural Success for Astron and Pulsar Stent | 98.0 Percentage of participants |
Secondary
Clinical Success
Evaluate the 30-day clinical success of the procedure. The 30-day clinical success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs within 30 days of the index procedure.
Time frame: 30 days
Population: The Astron stent group includes all participants who underwent implantation. The Pulsar stent group includes all participants who underwent implantation except for one, due to subject death occurring in the first 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Clinical Success | 95.0 Percentage of participants |
| Pulsar Stent Group | Clinical Success | 97.7 Percentage of participants |
Secondary
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success
Compare the 30-day clinical success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time frame: 30 days
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success | 97.7 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success | 97.2 Percentage of participants |
Secondary
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success
Compare the acute procedure success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time frame: Acute / Date of Procedure
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success | 98.1 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success | 97.3 Percentage of participants |
Secondary
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate
Compare the MAE rate results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate | 10.9 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate | 25.0 Percentage of participants |
Secondary
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months
Compare the primary assisted patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months | 99.2 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months | 97.1 Percentage of participants |
Secondary
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months
Compare the primary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months | 68.5 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months | 54.5 Percentage of participants |
Secondary
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months
Compare the secondary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months | 98.8 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months | 94.1 Percentage of participants |
Secondary
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months
Compare the stent fracture rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months | 4.7 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months | 13.3 Percentage of participants |
Secondary
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success
Compare the 30-day clinical success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time frame: 30 days
Population: Includes all participants who underwent implantation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success | 100.0 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success | 94.6 Percentage of participants |
| Pulsar Stent Group - Occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success | 97.8 Percentage of participants |
| Pulsar Stent Group - Non-occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success | 97.6 Percentage of participants |
Secondary
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate
Compare the 30 day MAE rate results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time frame: 30 days
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate | 0.0 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate | 2.2 Percentage of participants |
| Pulsar Stent Group - Occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate | 0.0 Percentage of participants |
| Pulsar Stent Group - Non-occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate | 0.5 Percentage of participants |
Secondary
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success
Compare the acute procedure success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time frame: Acute / Date of Procedure
Population: Includes all participants who underwent implantation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success | 100.0 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success | 94.6 Percentage of participants |
| Pulsar Stent Group - Occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success | 97.8 Percentage of participants |
| Pulsar Stent Group - Non-occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success | 98.1 Percentage of participants |
Secondary
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months
Compare the primary assisted patency (freedom from remote TVR) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months | 100.0 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months | 97.8 Percentage of participants |
| Pulsar Stent Group - Occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months | 96.4 Percentage of participants |
| Pulsar Stent Group - Non-occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months | 100.0 Percentage of participants |
Secondary
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months
Compare the primary patency at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months | 80.0 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months | 90.7 Percentage of participants |
| Pulsar Stent Group - Occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months | 59.8 Percentage of participants |
| Pulsar Stent Group - Non-occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months | 69.9 Percentage of participants |
Secondary
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months
Compare the secondary patency (freedom from bypass and amputation of the target limb) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months | 100.0 Percentage of participants |
| Pulsar Stent Group | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months | 99.3 Percentage of participants |
| Pulsar Stent Group - Occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months | 97.6 Percentage of participants |
| Pulsar Stent Group - Non-occlusive Lesion | Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months | 98.4 Percentage of participants |
Secondary
Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement
The purpose of this endpoint is to compare the ABI measurements between baseline and 12 months post-index procedure. ABI is the ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm.
Time frame: 12 months
Population: Analysis conducted on paired data. ABI measurements were available for 141 participants from both baseline and the 12-month visit for the Astron stent group. ABI measurements were available for 266 participants from both baseline and the 12-month visit for the Pulsar stent group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement | Baseline ABI | 0.71 Ratio (ABI score) | Standard Deviation 0.15 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement | 12-Month Visit ABI | 0.94 Ratio (ABI score) | Standard Deviation 0.18 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement | ABI difference | 0.23 Ratio (ABI score) | Standard Deviation 0.19 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement | Baseline ABI | 0.70 Ratio (ABI score) | Standard Deviation 0.14 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement | 12-Month Visit ABI | 0.91 Ratio (ABI score) | Standard Deviation 0.19 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement | ABI difference | 0.22 Ratio (ABI score) | Standard Deviation 0.21 |
Secondary
Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test
The purpose of this endpoint is to compare the distance walked during the 6-minute walk test between baseline and 12 months post-index procedure.
Time frame: 12 months
Population: Analysis conducted on paired data. Six-minute walk test results were available for 131 participants from both baseline and the 12-month visit for the Astron stent group. Six-minute walk test results were available for 247 participants from both baseline and the 12-month visit for the Pulsar stent group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test | Six-minute walk distance at baseline | 868.9 Feet | Standard Deviation 446.5 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test | Six-minute walk distance at 12-month visit | 1026.4 Feet | Standard Deviation 469.5 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test | Six-minute walk distance difference | 157.5 Feet | Standard Deviation 420.6 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test | Six-minute walk distance difference | 213.6 Feet | Standard Deviation 412.7 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test | Six-minute walk distance at baseline | 875.3 Feet | Standard Deviation 379.1 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test | Six-minute walk distance at 12-month visit | 1088.9 Feet | Standard Deviation 468.9 |
Secondary
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score
The purpose of this endpoint is to compare Walking Impairment Questionnaire (WIQ) Peripheral Arterial Disease (PAD) specific score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621
Time frame: 12 months
Population: Analysis conducted on paired data. WIQ PAD responses were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ PAD responses were available for 265 participants from both baseline and the 12-month visit for the Pulsar stent group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score | WIQ PAD Specific Score at Baseline | 36.2 Units on a scale (WIQ score) | Standard Deviation 29 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score | WIQ PAD Specific Score at 12-Month Visit | 80.1 Units on a scale (WIQ score) | Standard Deviation 29.2 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score | WIQ PAD Specific Score Difference | 43.9 Units on a scale (WIQ score) | Standard Deviation 36.8 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score | WIQ PAD Specific Score at Baseline | 36.7 Units on a scale (WIQ score) | Standard Deviation 28.1 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score | WIQ PAD Specific Score at 12-Month Visit | 75.8 Units on a scale (WIQ score) | Standard Deviation 32.3 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score | WIQ PAD Specific Score Difference | 39.1 Units on a scale (WIQ score) | Standard Deviation 40.4 |
Secondary
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score
The purpose of this endpoint is to compare Walking Impairment Questionnaire Stair Climbing score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621
Time frame: 12 months
Population: Analysis conducted on paired data. WIQ stair climbing scores were available for 142 participants from both baseline and the 12-month visit for the Astron stent group. WIQ stair climbing scores were available for 255 participants from both baseline and the 12-month visit for the Pulsar stent group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score | WIQ Stair Climbing Score at Baseline | 30.0 Units on a scale (WIQ score) | Standard Deviation 27.1 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score | WIQ Stair Climbing Score at 12-Month Visit | 56.1 Units on a scale (WIQ score) | Standard Deviation 36.8 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score | WIQ Stair Climbing Score Difference | 26.1 Units on a scale (WIQ score) | Standard Deviation 35.6 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score | WIQ Stair Climbing Score at Baseline | 36.8 Units on a scale (WIQ score) | Standard Deviation 31.5 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score | WIQ Stair Climbing Score at 12-Month Visit | 56.9 Units on a scale (WIQ score) | Standard Deviation 37.8 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score | WIQ Stair Climbing Score Difference | 20.1 Units on a scale (WIQ score) | Standard Deviation 36 |
Secondary
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score
The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Distance score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621
Time frame: 12 months
Population: Analysis conducted on paired data. WIQ walking distance scores were available for 144 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking distance scores were available for 264 participants from both baseline and the 12-month visit for the Pulsar stent group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score | WIQ Walking Dist Score at Baseline | 21.3 Units on a scale (WIQ score) | Standard Deviation 24.2 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score | WIQ Walking Dist Score at 12-Month Visit | 62.0 Units on a scale (WIQ score) | Standard Deviation 39.5 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score | WIQ Walking Dist Score Difference | 40.7 Units on a scale (WIQ score) | Standard Deviation 38 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score | WIQ Walking Dist Score at Baseline | 26.1 Units on a scale (WIQ score) | Standard Deviation 26.3 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score | WIQ Walking Dist Score at 12-Month Visit | 58.7 Units on a scale (WIQ score) | Standard Deviation 38.9 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score | WIQ Walking Dist Score Difference | 32.6 Units on a scale (WIQ score) | Standard Deviation 37.4 |
Secondary
Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score
The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Speed score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information: Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621
Time frame: 12 months
Population: Analysis conducted on paired data. WIQ walking speed scores were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking speed scores were available for 263 participants from both baseline and the 12-month visit for the Pulsar stent group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score | WIQ Walking Speed Score at 12-Month Visit | 43.8 Units on a scale (WIQ score) | Standard Deviation 28.6 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score | WIQ Walking Speed Score Difference | 21.5 Units on a scale (WIQ score) | Standard Deviation 27.5 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score | WIQ Walking Speed Score at Baseline | 22.3 Units on a scale (WIQ score) | Standard Deviation 19.2 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score | WIQ Walking Speed Score at 12-Month Visit | 43.5 Units on a scale (WIQ score) | Standard Deviation 28 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score | WIQ Walking Speed Score Difference | 18.3 Units on a scale (WIQ score) | Standard Deviation 28.1 |
| Pulsar Stent Group | Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score | WIQ Walking Speed Score at Baseline | 25.2 Units on a scale (WIQ score) | Standard Deviation 21.2 |
Secondary
Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate
Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate.
Time frame: 12 months
Population: Participants who reached at least 395 calendar days post procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pulsar Stent Group | Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate | 30-day mortality | 0.4 Percentage of participants |
| Pulsar Stent Group | Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate | Target lesion revascularization | 12.4 Percentage of participants |
| Pulsar Stent Group | Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate | Index limb amputation | 0.4 Percentage of participants |
Secondary
Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval)
Evaluate the rate of freedom from target lesion revascularization (TLR) and/or index limb amputation for the Pulsar stent.
Time frame: 24 Months
Population: Evaluable participants for TLR at 24 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulsar Stent Group | Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval) | 217 Participants |
Secondary
Number of Participants With Stent Fracture at 24 Months (Post Approval).
Time frame: 24 Months
Population: Evaluable participants for stent fracture at 24 months. Pulsar Stent Group Post Market Analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulsar Stent Group | Number of Participants With Stent Fracture at 24 Months (Post Approval). | 10 Participants |
Secondary
Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group).
Time frame: 36 Months
Population: Evaluable participants for stent fracture at 36 months. Pulsar Stent Group Post Market Analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulsar Stent Group | Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group). | 13 Participants |
Secondary
Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval).
Evaluate the MAE rate and the individual component rates of mortality at 30 days post-index procedure, target lesion revascularization (TLR) and index limb amputation for the Pulsar stent.
Time frame: 36 Months
Population: Evaluable participants at 36 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pulsar Stent Group | Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval). | MAE - Related to stent or index procedure | 22.1 percentage of participants |
| Pulsar Stent Group | Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval). | - 30-day mortality | 0.4 percentage of participants |
| Pulsar Stent Group | Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval). | - Clinically-driven TLR | 21.8 percentage of participants |
| Pulsar Stent Group | Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval). | - Index limb amputation | 1.2 percentage of participants |
Secondary
Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group)
Time frame: 24 Months
Population: Evaluable participants for TLR at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group) | 20.9 percentage of Participants |
Secondary
Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group)
Time frame: 36 Months
Population: Evaluable participants for TLR at 36 months. Pulsar Stent Group Post Market Analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group) | 23.7 percentage of participants |
Secondary
Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group).
Summary of serious adverse event rates at 36 months. Refer to SAE section.
Time frame: 36 months
Population: Pulsar Stent Group Post Market Analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulsar Stent Group | Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group). | 230 Participants |
Secondary
Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval)
Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.
Time frame: 24 Months
Population: Evaluable participants at 24 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pulsar Stent Group | Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval) | MAE - Related to stent or index procedure | 19.3 percentage of participants |
| Pulsar Stent Group | Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval) | 30-day mortality | 0.4 percentage of participants |
| Pulsar Stent Group | Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval) | Clinically-driven TLR | 19.0 percentage of participants |
| Pulsar Stent Group | Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval) | Index limb amputation | 0.8 percentage of participants |
Secondary
Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency
Evaluate the primary assisted patency rate (freedom from remote Target Vessel Revascularization \[TVR\]) for the Astron and Pulsar stent at 12 months post-index procedure.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency | 97.9 Percentage of participants |
| Pulsar Stent Group | Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency | 98.9 Percentage of participants |
Secondary
Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency
Evaluate the secondary patency rate (freedom from bypass and amputation of the target limb) for the Astron and Pulsar stent at 12 months post-index procedure.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency | 99.3 Percentage of participants |
| Pulsar Stent Group | Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency | 98.2 Percentage of participants |
Secondary
Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate
Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of \> 50% stenosis.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsar Stent Group | Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate | 89.8 Percentage of participants |
Secondary
Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates
Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group. Please see the Serious Adverse Events and Other Adverse Events sections for event details.
Time frame: 12 month
Population: Includes all participants who underwent implantation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pulsar Stent Group | Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates | Serious adverse events | 67 Participants with event |
| Pulsar Stent Group | Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates | Non-serious adverse events | 94 Participants with event |
| Pulsar Stent Group | Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates | Serious adverse events | 180 Participants with event |
| Pulsar Stent Group | Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates | Non-serious adverse events | 277 Participants with event |
Secondary
Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate
Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent.
Time frame: 12 months
Population: Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pulsar Stent Group | Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate | 30-day mortality | 0.7 Percentage of participants |
| Pulsar Stent Group | Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate | Target Lesion Revascularization | 1.4 Percentage of participants |
| Pulsar Stent Group | Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate | Index limb amputation | 0.0 Percentage of participants |
Secondary
Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation
Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.
Time frame: 30 days
Population: All participants implanted with an Astron Pulsar or Pulsar-18 stent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pulsar Stent Group | Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation | Freedom from 30 day mortality | 99.7 Percentage of participants |
| Pulsar Stent Group | Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation | Freedom from 30 day TLR | 100.0 Percentage of participants |
| Pulsar Stent Group | Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation | Freedom from 30 day index limb amputation | 100.0 Percentage of participants |
Secondary
Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate
Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure. An independent angiographic core laboratory reviewed x-ray imaging for presence or absence of a stent fracture. Fractures were assessed with Grade I indicating a single tine fracture, Grade II indicating multiple tine fracture, Grade III indicating stent fracture(s) with preserved alignment of the components, Grade IV indicating stent fracture(s) with mal-alignment of the components, and Grade V stent fracture(s) in a trans-axial spiral configuration. Generally, fractures of Grade I are least severe, increasing in severity to Grade V.
Time frame: 12 months
Population: Participants with 12 month (395 day) diagnostic X-ray available for fracture evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pulsar Stent Group | Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate | Overall stent fracture at 12 months | 14 Participants |
| Pulsar Stent Group | Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate | Grade I stent fracture at 12 months | 4 Participants |
| Pulsar Stent Group | Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate | Grade II stent fracture at 12 months | 3 Participants |
| Pulsar Stent Group | Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate | Grade III stent fracture at 12 months | 3 Participants |
| Pulsar Stent Group | Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate | Grade IV stent fracture at 12 months | 4 Participants |
| Pulsar Stent Group | Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate | Grade V stent fracture at 12 months | 0 Participants |