Trial Outcomes & Findings for Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents (NCT NCT01319812)

NCT ID: NCT01319812

Last Updated: 2019-03-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

463 participants

Primary outcome timeframe

12 months

Results posted on

2019-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Astron Stent Group Subjects implanted with an Astron stent.	Pulsar Stent Group Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
Overall Study STARTED	161	302
Overall Study COMPLETED	145	280
Overall Study NOT COMPLETED	16	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Astron Stent Group n=161 Participants Subjects implanted with an Astron stent.	Pulsar Stent Group n=302 Participants Subjects implanted with an Astron Pulsar or Pulsar-18 stent.	Total n=463 Participants Total of all reporting groups
Age, Continuous	63.6 Years STANDARD_DEVIATION 10.1 • n=5 Participants	67.3 Years STANDARD_DEVIATION 10.3 • n=7 Participants	NA Years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	97 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants	205 Participants n=7 Participants	310 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	143 Participants n=5 Participants	281 Participants n=7 Participants	424 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	22 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	152 Participants n=5 Participants	273 Participants n=7 Participants	425 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	91 Participants n=5 Participants	187 Participants n=7 Participants	NA Participants n=5 Participants
Region of Enrollment Canada	38 Participants n=5 Participants	29 Participants n=7 Participants	NA Participants n=5 Participants
Region of Enrollment Austria	32 Participants n=5 Participants	34 Participants n=7 Participants	NA Participants n=5 Participants
Region of Enrollment Belgium	0 Participants n=5 Participants	32 Participants n=7 Participants	NA Participants n=5 Participants
Region of Enrollment Switzerland	0 Participants n=5 Participants	6 Participants n=7 Participants	NA Participants n=5 Participants
Region of Enrollment Germany	0 Participants n=5 Participants	14 Participants n=7 Participants	NA Participants n=5 Participants
Medical History Diabetes	32 Participants n=5 Participants	123 Participants n=7 Participants	NA Participants n=5 Participants
Medical History Hypertension	117 Participants n=5 Participants	255 Participants n=7 Participants	NA Participants n=5 Participants
Medical History Hyperlipidemia	125 Participants n=5 Participants	245 Participants n=7 Participants	NA Participants n=5 Participants
Medical History Current smoker	78 Participants n=5 Participants	122 Participants n=7 Participants	NA Participants n=5 Participants
Medical History Smoked within last 5 years	36 Participants n=5 Participants	46 Participants n=7 Participants	NA Participants n=5 Participants
Medical History Never smoked or not within last 5 years	47 Participants n=5 Participants	134 Participants n=7 Participants	NA Participants n=5 Participants
Medical History Cerebrovascular disease	22 Participants n=5 Participants	48 Participants n=7 Participants	NA Participants n=5 Participants
Medical History History of congestive heart failure	11 Participants n=5 Participants	27 Participants n=7 Participants	NA Participants n=5 Participants
Medical History History of ischemic heart disease	69 Participants n=5 Participants	124 Participants n=7 Participants	NA Participants n=5 Participants
Medical History History of coronary revasularization	54 Participants n=5 Participants	110 Participants n=7 Participants	NA Participants n=5 Participants
Medical History Renal insufficiency	11 Participants n=5 Participants	17 Participants n=7 Participants	NA Participants n=5 Participants
Lesion Location Common iliac	107 Participants n=5 Participants	0 Participants n=7 Participants	107 Participants n=5 Participants
Lesion Location External iliac	54 Participants n=5 Participants	0 Participants n=7 Participants	54 Participants n=5 Participants
Lesion Location Ostial SFA	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Lesion Location Proximal SFA	0 Participants n=5 Participants	38 Participants n=7 Participants	38 Participants n=5 Participants
Lesion Location Mid SFA	0 Participants n=5 Participants	156 Participants n=7 Participants	156 Participants n=5 Participants
Lesion Location Distal SFA	0 Participants n=5 Participants	99 Participants n=7 Participants	99 Participants n=5 Participants
Lesion Location Proximal popliteal	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Lesion Calcification None	47 Participants n=5 Participants	82 Participants n=7 Participants	NA Participants n=5 Participants
Lesion Calcification Moderate	68 Participants n=5 Participants	91 Participants n=7 Participants	NA Participants n=5 Participants
Lesion Calcification Severe	46 Participants n=5 Participants	129 Participants n=7 Participants	NA Participants n=5 Participants
Lesion Length	35.9 mm STANDARD_DEVIATION 21.3 • n=5 Participants	82.0 mm STANDARD_DEVIATION 46.9 • n=7 Participants	NA mm STANDARD_DEVIATION NA • n=5 Participants
Vessel Diameter Pre-deployment Minimum Lumen Diameter (MLD)	2.1 mm STANDARD_DEVIATION 1.3 • n=5 Participants	1.0 mm STANDARD_DEVIATION 0.9 • n=7 Participants	NA mm STANDARD_DEVIATION NA • n=5 Participants
Vessel Diameter Post-deployment Minimum Lumen Diameter (MLD)	6.0 mm STANDARD_DEVIATION 1.2 • n=5 Participants	4.1 mm STANDARD_DEVIATION 0.7 • n=7 Participants	NA mm STANDARD_DEVIATION NA • n=5 Participants
Vessel Diameter Reference vessel diameter	7.6 mm STANDARD_DEVIATION 1.5 • n=5 Participants	5.0 mm STANDARD_DEVIATION 0.9 • n=7 Participants	NA mm STANDARD_DEVIATION NA • n=5 Participants
Distal Vessel Runoff Not Available	35 Participants n=5 Participants	32 Participants n=7 Participants	NA Participants n=5 Participants
Distal Vessel Runoff 0 Vessel	9 Participants n=5 Participants	19 Participants n=7 Participants	NA Participants n=5 Participants
Distal Vessel Runoff 1 Vessel	32 Participants n=5 Participants	74 Participants n=7 Participants	NA Participants n=5 Participants
Distal Vessel Runoff 2 Vessel	48 Participants n=5 Participants	93 Participants n=7 Participants	NA Participants n=5 Participants
Distal Vessel Runoff 3 Vessel	37 Participants n=5 Participants	84 Participants n=7 Participants	NA Participants n=5 Participants
Trans-Atlantic Inter-Society Consensus (TASC II) Type Type A	99 Participants n=5 Participants	166 Participants n=7 Participants	NA Participants n=5 Participants
Trans-Atlantic Inter-Society Consensus (TASC II) Type Type B	56 Participants n=5 Participants	106 Participants n=7 Participants	NA Participants n=5 Participants
Trans-Atlantic Inter-Society Consensus (TASC II) Type Type C	6 Participants n=5 Participants	26 Participants n=7 Participants	NA Participants n=5 Participants
Trans-Atlantic Inter-Society Consensus (TASC II) Type Type D	0 Participants n=5 Participants	3 Participants n=7 Participants	NA Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Participants for whom patency could be confirmed at 12 months.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=268 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Effectiveness Endpoint for the Pulsar Stent: Primary Patency	66.8 Percentage of participants Interval 60.8 to 72.4	—	—	—

PRIMARY outcome

Timeframe: 30 days

Population: All participants implanted with an Astron Pulsar or Pulsar-18 stent.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=302 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events	99.7 Percentage of participants Interval 98.2 to 100.0	—	—	—

PRIMARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.

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%.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=146 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)	2.1 Percentage of participants Interval 0.4 to 5.9	—	—	—

PRIMARY outcome

Timeframe: 36 Months

Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=257 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Percentage of Participants With Primary Safety Endpoint (Post Market Analysis)	78.2 percentage of participants Interval 72.7 to 83.1	—	—	—

SECONDARY outcome

Timeframe: 30 days

Population: All participants implanted with an Astron Pulsar or Pulsar-18 stent.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=302 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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 Interval 98.2 to 100.0	—	—	—
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 Interval 98.8 to 100.0	—	—	—
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 Interval 98.8 to 100.0	—	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Participants who reached at least 395 calendar days post procedure.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=283 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate 30-day mortality	0.4 Percentage of participants Interval 0.0 to 2.0	—	—	—
Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate Target lesion revascularization	12.4 Percentage of participants Interval 8.8 to 16.8	—	—	—
Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate Index limb amputation	0.4 Percentage of participants Interval 0.0 to 2.0	—	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Participants with 12 month (395 day) diagnostic X-ray available for fracture evaluation.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=243 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate Overall stent fracture at 12 months	14 Participants	—	—	—
Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate Grade I stent fracture at 12 months	4 Participants	—	—	—
Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate Grade II stent fracture at 12 months	3 Participants	—	—	—
Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate Grade III stent fracture at 12 months	3 Participants	—	—	—
Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate Grade IV stent fracture at 12 months	4 Participants	—	—	—
Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate Grade V stent fracture at 12 months	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=146 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate 30-day mortality	0.7 Percentage of participants Interval 0.0 to 3.8	—	—	—
Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate Target Lesion Revascularization	1.4 Percentage of participants Interval 0.2 to 4.5	—	—	—
Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate Index limb amputation	0.0 Percentage of participants Interval 0.0 to 2.5	—	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=128 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate	89.8 Percentage of participants Interval 83.3 to 94.5	—	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=146 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=275 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency	97.9 Percentage of participants Interval 94.1 to 99.6	98.9 Percentage of participants Interval 96.8 to 99.8	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=146 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=276 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency	99.3 Percentage of participants Interval 96.2 to 100.0	98.2 Percentage of participants Interval 95.8 to 99.4	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=141 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=266 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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	0.70 Ratio (ABI score) Standard Deviation 0.14	—	—
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	0.91 Ratio (ABI score) Standard Deviation 0.19	—	—
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	0.22 Ratio (ABI score) Standard Deviation 0.21	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=131 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=247 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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	875.3 Feet Standard Deviation 379.1	—	—
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	1088.9 Feet Standard Deviation 468.9	—	—
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	213.6 Feet Standard Deviation 412.7	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=143 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=265 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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 29.0	36.7 Units on a scale (WIQ score) Standard Deviation 28.1	—	—
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	75.8 Units on a scale (WIQ score) Standard Deviation 32.3	—	—
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	39.1 Units on a scale (WIQ score) Standard Deviation 40.4	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=144 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=264 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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 38.0	32.6 Units on a scale (WIQ score) Standard Deviation 37.4	—	—
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	26.1 Units on a scale (WIQ score) Standard Deviation 26.3	—	—
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	58.7 Units on a scale (WIQ score) Standard Deviation 38.9	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=143 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=263 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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	43.5 Units on a scale (WIQ score) Standard Deviation 28.0	—	—
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	25.2 Units on a scale (WIQ score) Standard Deviation 21.2	—	—
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	18.3 Units on a scale (WIQ score) Standard Deviation 28.1	—	—

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=142 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=255 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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	36.8 Units on a scale (WIQ score) Standard Deviation 31.5	—	—
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	56.9 Units on a scale (WIQ score) Standard Deviation 37.8	—	—
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	20.1 Units on a scale (WIQ score) Standard Deviation 36.0	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Includes all participants who underwent implantation.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=161 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=302 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Acute Procedural Success for Astron and Pulsar Stent	95.0 Percentage of participants Interval 90.4 to 97.8	98.0 Percentage of participants Interval 95.7 to 99.3	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=161 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=301 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Clinical Success	95.0 Percentage of participants Interval 90.4 to 97.8	97.7 Percentage of participants Interval 95.3 to 99.1	—	—

SECONDARY outcome

Timeframe: 12 month

Population: Includes all participants who underwent implantation.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=161 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=302 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates Serious adverse events	67 Participants with event	180 Participants with event	—	—
Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates Non-serious adverse events	94 Participants with event	277 Participants with event	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=12 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=134 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion n=91 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion n=211 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate	0.0 Percentage of participants	2.2 Percentage of participants	0.0 Percentage of participants	0.5 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=10 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=118 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion n=82 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion n=186 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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	90.7 Percentage of participants	59.8 Percentage of participants	69.9 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=12 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=134 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion n=83 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion n=192 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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	97.8 Percentage of participants	96.4 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=12 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=134 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion n=84 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion n=192 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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	99.3 Percentage of participants	97.6 Percentage of participants	98.4 Percentage of participants

SECONDARY outcome

Timeframe: Acute / Date of Procedure

Population: Includes all participants who underwent implantation.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=13 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=148 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion n=91 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion n=211 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success	100.0 Percentage of participants	94.6 Percentage of participants	97.8 Percentage of participants	98.1 Percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Includes all participants who underwent implantation.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=13 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=148 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion n=90 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion n=211 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success	100.0 Percentage of participants	94.6 Percentage of participants	97.8 Percentage of participants	97.6 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=247 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=36 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate	10.9 Percentage of participants	25.0 Percentage of participants	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=235 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=33 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months	68.5 Percentage of participants	54.5 Percentage of participants	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=213 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=30 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months	4.7 Percentage of participants	13.3 Percentage of participants	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=241 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=34 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months	99.2 Percentage of participants	97.1 Percentage of participants	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=239 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=34 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months	98.8 Percentage of participants	94.1 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Acute / Date of Procedure

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=265 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=37 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success	98.1 Percentage of participants	97.3 Percentage of participants	—	—

SECONDARY outcome

Timeframe: 30 days

Population: Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.

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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=265 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group n=36 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success	97.7 Percentage of participants	97.2 Percentage of participants	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: Evaluable participants for TLR at 24 months.

Evaluate the rate of freedom from target lesion revascularization (TLR) and/or index limb amputation for the Pulsar stent.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=268 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval)	217 Participants	—	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: Evaluable participants at 24 months.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=269 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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 Interval 14.8 to 24.6	—	—	—
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 Interval 0.0 to 2.1	—	—	—
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 Interval 14.5 to 24.2	—	—	—
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 Interval 0.01 to 2.7	—	—	—

SECONDARY outcome

Timeframe: 36 Months

Population: Evaluable participants at 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.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=258 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
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 Interval 17.2 to 27.7	—	—	—
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 Interval 0.0 to 2.1	—	—	—
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 Interval 16.9 to 27.3	—	—	—
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 Interval 0.2 to 3.4	—	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: Evaluable participants for TLR at 24 months.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=268 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group)	20.9 percentage of Participants Interval 16.2 to 26.3	—	—	—

SECONDARY outcome

Timeframe: 36 Months

Population: Evaluable participants for TLR at 36 months. Pulsar Stent Group Post Market Analysis.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=257 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group)	23.7 percentage of participants Interval 18.7 to 29.4	—	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: Evaluable participants for stent fracture at 24 months. Pulsar Stent Group Post Market Analysis.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=230 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Number of Participants With Stent Fracture at 24 Months (Post Approval).	10 Participants	—	—	—

SECONDARY outcome

Timeframe: 36 Months

Population: Evaluable participants for stent fracture at 36 months. Pulsar Stent Group Post Market Analysis.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=204 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group).	13 Participants	—	—	—

SECONDARY outcome

Timeframe: 36 months

Population: Pulsar Stent Group Post Market Analysis.

Summary of serious adverse event rates at 36 months. Refer to SAE section.

Outcome measures

Outcome measures
Measure	Pulsar Stent Group n=302 Participants Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.	Pulsar Stent Group - Occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).	Pulsar Stent Group - Non-occlusive Lesion Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group).	230 Participants	—	—	—

Adverse Events

Astron Stent Group

Serious events: 67 serious events

Other events: 33 other events

Deaths: 5 deaths

Pulsar Stent Group

Serious events: 180 serious events

Other events: 179 other events

Deaths: 27 deaths

Serious adverse events

Other adverse events

Additional Information

Amy Culley, Director of Vascular Intervention

BIOTRONIK

Phone: 503-451-8034

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Astron Stent Group n=161 participants at risk Subjects indicated for stenting in iliac atherosclerotic lesions.	Pulsar Stent Group n=302 participants at risk Subjects indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Blood and lymphatic system disorders Anemia	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	5.3% 16/302 • Number of events 17 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Cardiac disorders Chest pain	5.0% 8/161 • Number of events 11 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	7.9% 24/302 • Number of events 26 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Cardiac disorders Dizziness/ lightheadedness	5.0% 8/161 • Number of events 8 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	5.6% 17/302 • Number of events 20 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Cardiac disorders Dyspnea	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	7.6% 23/302 • Number of events 26 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Cardiac disorders Edema	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	10.9% 33/302 • Number of events 38 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Cardiac disorders Hypertension	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	7.3% 22/302 • Number of events 25 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Musculoskeletal and connective tissue disorders Leg pain and/or cramping	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	5.3% 16/302 • Number of events 17 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	14.3% 23/161 • Number of events 24 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	22.2% 67/302 • Number of events 96 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Musculoskeletal and connective tissue disorders Numbness and/or tingling in lower extremities	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	5.3% 16/302 • Number of events 17 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Renal and urinary disorders Urinary tract infection	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	6.3% 19/302 • Number of events 23 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Skin and subcutaneous tissue disorders Skin condition/rash	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	5.3% 16/302 • Number of events 20 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Surgical and medical procedures Hematoma - Non-index procedure related	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	7.9% 24/302 • Number of events 27 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Vascular disorders Stenosis or occlusion in contralateral extremity	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	12.9% 39/302 • Number of events 46 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Vascular disorders Stenosis or occlusion in target exremity outside of stent segment	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	7.6% 23/302 • Number of events 27 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.
Vascular disorders Stenosis or occlusion of target lesion within stent segment	0.00% 0/161 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.	12.9% 39/302 • Number of events 46 • Enrollment through 12-months post-procedure for Astron group Serious and Non-serious Adverse Events. Enrollment through 36-months post-procedure for Pulsar group Serious and Non-serious Adverse Events. For non-serious adverse events with 0 listed for Astron, there may have been events reported for the category however the number events did not reach the 5% threshold for reporting.