Trial Outcomes & Findings for Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy (NCT NCT05529472)

Last Updated: 2025-10-27

Results Overview

The percentage of subjects with the following, post-procedure: 1. ≤50% residual stenosis post OAD + POBA \[Angiographic Core Lab assessed\] and, 2. No OAS-related severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\].

Recruitment status

COMPLETED

Study phase

Target enrollment

81 participants

Primary outcome timeframe

At the end of the procedure

Results posted on

2025-10-27

Participant Flow

81 subjects were enrolled at 12 Japanese sites between 10January2023 and 19March2024 with 14 subjects in roll-in cohort and 67 in full analysis set (FAS). Subjects were considered to enrolled in study at time point of Peripheral Orbital Atherectomy System (OAS) guide wire entered body and became part of ITT population (N=67). 66 subjects became mITT population,1could not confirm calcification due to insufficient imaging. All 14 roll-in subjects were analyzed separately from enrolled population.

The 14 subjects enrolled in a roll-in cohort, were conducted as part of the site initiation phase to allow operating investigators for procedural training with the investigational device. These roll-in subjects were not included in the Full Analysis Set (FAS) and were not part of the reported results in Participant Flow, Baseline Characteristics, Outcome Measures, or Adverse Events modules, as predefined in the statistical analysis plan.

Participant milestones

Participant milestones
Measure	Analysis Cohort [Peripheral Orbital Atherectomy System (OAS)] Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™	Roll-in Cohort [Peripheral Orbital Atherectomy System(OAS)] Roll-in subjects were initial cases by the investigator enrolled to ensure proper device training, and procedural and data collection adherence. Roll-in subjects were consented, treated, and followed per protocol. Roll-in subject data was reported and analyzed separately from the Analysis Cohort.
Overall Study STARTED	67	14
Overall Study COMPLETED	66	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Analysis Cohort [Peripheral Orbital Atherectomy System (OAS)] Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™	Roll-in Cohort [Peripheral Orbital Atherectomy System(OAS)] Roll-in subjects were initial cases by the investigator enrolled to ensure proper device training, and procedural and data collection adherence. Roll-in subjects were consented, treated, and followed per protocol. Roll-in subject data was reported and analyzed separately from the Analysis Cohort.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™	Roll-in Cohort [Peripheral Orbital Atherectomy System(OAS)] n=14 Participants Roll-in subjects were initial cases by the investigator enrolled to ensure proper device training, and procedural and data collection adherence. Roll-in subjects were consented, treated, and followed per protocol. Roll-in subject data was reported and analyzed separately from the Analysis Cohort.	Total n=81 Participants Total of all reporting groups
Age, Continuous	75.6 years STANDARD_DEVIATION 7.51 • n=5 Participants	73.6 years STANDARD_DEVIATION 7.91 • n=7 Participants	74.6 years STANDARD_DEVIATION 7.71 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	3 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	11 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	67 Participants n=5 Participants	14 Participants n=7 Participants	81 Participants n=5 Participants
Body mass index	23.1 kg/m² STANDARD_DEVIATION 3.61 • n=5 Participants	24.2 kg/m² STANDARD_DEVIATION 3.68 • n=7 Participants	23.65 kg/m² STANDARD_DEVIATION 3.64 • n=5 Participants
Rutherford classification Moderate Claudication (RC2)	20 Participants n=5 Participants	6 Participants n=7 Participants	26 Participants n=5 Participants
Rutherford classification Severe Claudication (RC3)	39 Participants n=5 Participants	8 Participants n=7 Participants	47 Participants n=5 Participants
Rutherford classification Ischemic rest pain (RC4)	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Serum Creatinine	3.1 mg/dl STANDARD_DEVIATION 3.12 • n=5 Participants	3.5 mg/dl STANDARD_DEVIATION 3.79 • n=7 Participants	3.3 mg/dl STANDARD_DEVIATION 3.45 • n=5 Participants

PRIMARY outcome

Timeframe: At the end of the procedure

Population: The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol.

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=66 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Percentage of Subjects With Acute Device Success	55 Participants

SECONDARY outcome

Timeframe: Baseline, Post OAD, Post POBA

Population: The ITT population included all enrolled 67 subjects who have been treated with the OAD regardless of deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of 67 enrolled subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects

The percentage changes in diameter stenosis of the target lesion at each stage of the procedure: Baseline, Post OAD, Post POBA and Post DCB \[Angiographic Core Lab assessed\].

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Change in Lesion Stenosis Baseline (ITT population)	73.7 percentage of stenosis Standard Deviation 14.54
Change in Lesion Stenosis Post final OAD (ITT population)	47.8 percentage of stenosis Standard Deviation 11.96
Change in Lesion Stenosis Post POBA (ITT population)	23.2 percentage of stenosis Standard Deviation 10.25
Change in Lesion Stenosis Reduction in % Diameter Stenosis (Pre-procedure - Post OAD) (ITT population)	25.9 percentage of stenosis Standard Deviation 14.89
Change in Lesion Stenosis Reduction in % Diameter Stenosis (Pre-procedure - Post POBA) (ITT population)	50.5 percentage of stenosis Standard Deviation 17.80
Change in Lesion Stenosis Baseline (mITT population)	73.7 percentage of stenosis Standard Deviation 14.65
Change in Lesion Stenosis Post final OAD (mITT population)	47.9 percentage of stenosis Standard Deviation 12.04
Change in Lesion Stenosis Post POBA (mITT population)	23.1 percentage of stenosis Standard Deviation 10.31
Change in Lesion Stenosis Reduction in % Diameter Stenosis (Pre-procedure - Post OAD) (mITT population)	25.8 percentage of stenosis Standard Deviation 14.99
Change in Lesion Stenosis Reduction in % Diameter Stenosis (Pre-procedure - Post POBA) (mITT population)	50.5 percentage of stenosis Standard Deviation 17.93

SECONDARY outcome

Timeframe: At the end of the procedure

Population: The ITT population included all enrolled 67 subjects who have been treated with the OAD regardless of deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of enrolled 67 subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects.

Acute technical success defined per the Peripheral Academic Research Consortium (PARC) definition of achievement of a final residual stenosis \<30% for stented and \<50% for non-stented subjects by angiography at the end of the procedure \[Angiographic Core Lab assessed\] without severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\].

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Acute Technical Success ITT population	56 Participants
Acute Technical Success mITT population	55 Participants

SECONDARY outcome

Timeframe: Within 3 minutes of insertion of DCB

DCB Device Success defined as the ability to achieve successful delivery and deployment of all DCB to the target lesion as described per the Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device.

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Drug Coated Balloon (DCB) Device Success mITT population	98.5 percentage of participants Interval 91.8 to 100.0
Drug Coated Balloon (DCB) Device Success ITT Population	98.5 percentage of participants Interval 92.0 to 100.0

SECONDARY outcome

Timeframe: Up to 6 months

Target Vessel Patency is a binary composite endpoint comprised of: * CEC adjudicated absence of clinically driven repeat procedure performed for ≥50% stenosis confirmed by angiography within all or part of the target lesion after documentation of recurrent clinical symptoms of PAD following clinical trial treatment procedure (i.e. clinically-driven TLR) occurring at any time-point on, or prior to the 6-month visit date and, * a Duplex Ultrasound Core Lab assessed PSVR value of ≤2.4 (or equivalent by visual assessment if the lesion is non-patent and the PSVR cannot be numerically calculated). The vessel is considered patent if both criteria are met at the time of assessment.

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Target Vessel Patency ITT population	92.3 percentage of participants Interval 83.0 to 97.5
Target Vessel Patency mITT population	92.2 percentage of participants Interval 82.7 to 97.4

SECONDARY outcome

Timeframe: At the end of the procedure

Population: The FAS population included all subjects enrolled into the trial regardless of treatment with the OAD or deviations from the protocol. The mITT population set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol. Of 67 enrolled subjects, one could not confirm calcification due to insufficient imaging, resulting in mITT analysis population becoming 66 subjects

Rate of severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\]

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Rate of Severe Angiographic Complications Distal Emboli: FAS population	10 participants
Rate of Severe Angiographic Complications Dissection (D-F): mITT population	0 participants
Rate of Severe Angiographic Complications Perforation: mITT population	1 participants
Rate of Severe Angiographic Complications Distal Emboli: mITT population	10 participants
Rate of Severe Angiographic Complications Dissection (D-F): FAS population	0 participants
Rate of Severe Angiographic Complications Perforation: FAS population	1 participants

SECONDARY outcome

Timeframe: 72 hours after index procedure

Acute procedural success is defined as both acute technical success and absence of death, stroke, myocardial infarction (MI), acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery within 72 hours of the clinical trial treatment \[CEC adjudicated\].

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Acute Procedural Success FAS population	83.6 percentage of participants Interval 72.5 to 91.5
Acute Procedural Success mITT population	83.3 percentage of participants Interval 72.1 to 91.4

SECONDARY outcome

Timeframe: 30 days and 6 months

Major Adverse Event (MAE) rate at 30 days and 6 months (CEC adjudicated) was defined as: 1. All-cause death through 30 days or 2. Major amputation of the target limb or 3. Clinically-driven TLR

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Rate of Major Adverse Event (MAE) 30 days (FAS population) : All-cause death	0 Participants
Rate of Major Adverse Event (MAE) 30 days (FAS population) : Major amputation of the target limb	0 Participants
Rate of Major Adverse Event (MAE) 30 days (FAS population) : Clinically driven TLR	0 Participants
Rate of Major Adverse Event (MAE) 6 months (FAS population) : All-cause death	0 Participants
Rate of Major Adverse Event (MAE) 6 months (FAS population) : Major amputation of the target limb	0 Participants
Rate of Major Adverse Event (MAE) 6 months (FAS population) : Clinically driven TLR	1 Participants
Rate of Major Adverse Event (MAE) 30 days (mITT population) : All-cause death	0 Participants
Rate of Major Adverse Event (MAE) 30 days (mITT population) : Major amputation of the target limb	0 Participants
Rate of Major Adverse Event (MAE) 30 days (mITT population) : Clinically driven TLR	0 Participants
Rate of Major Adverse Event (MAE) 6 months (mITT population) : All-cause death	0 Participants
Rate of Major Adverse Event (MAE) 6 months (mITT population) : Major amputation of the target limb	0 Participants
Rate of Major Adverse Event (MAE) 6 months (mITT population) : Clinically driven TLR	1 Participants

SECONDARY outcome

Timeframe: Baseline, 30 days and 6 months

Population: Analysis population includes all enrolled ITT (intent to treat) subjects who have been treated with the OAD regardless of deviations from the protocol.

Rutherford Classification; Class 0: Asymptomatic; no hemodynamically significant occlusive disease. Class 1: Mild Claudication; there is no limitation with ordinary physical activities (e.g., walking several blocks, climbing stairs). Limiting symptoms may occur with marked exertion (e.g., strenuous, rapid or prolonged exertion at work or recreation). Class 2: Moderate Claudication; there is a slight limitation of ordinary physical activities (e.g., walking uphill, or more than two level blocks, or climbing stairs rapidly). Subject is comfortable at rest. Class 3: Severe Claudication; there is marked limitation of ordinary physical activities (e.g., walking 1-2 level blocks or climbing one flight of stairs). Subject is comfortable at rest. Class 4: Ischemic rest pain. Class 5: Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia. Class 6: Major tissue loss extending above transmetatarsal level; functional foot no longer salvageable.

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Change of Rutherford Classification (ITT Population) Baseline · Grade 0: Asymptomatic (0)	0 Participants
Change of Rutherford Classification (ITT Population) Baseline · Grade II :Ischemic Rest Pain (4)	8 Participants
Change of Rutherford Classification (ITT Population) Baseline · Grade III :Minor Tissue Loss (5)	0 Participants
Change of Rutherford Classification (ITT Population) Baseline · Grade I:Severe Claudication (3)	39 Participants
Change of Rutherford Classification (ITT Population) Baseline · Grade I:Moderate Claudication (2)	20 Participants
Change of Rutherford Classification (ITT Population) Baseline · Grade I:Mild Claudication (1)	0 Participants
Change of Rutherford Classification (ITT Population) 30 Days · Grade 0: Asymptomatic (0)	52 Participants
Change of Rutherford Classification (ITT Population) 30 Days · Grade I:Moderate Claudication (2)	1 Participants
Change of Rutherford Classification (ITT Population) 30 Days · Grade II :Ischemic Rest Pain (4)	0 Participants
Change of Rutherford Classification (ITT Population) 30 Days · Grade III :Minor Tissue Loss (5)	0 Participants
Change of Rutherford Classification (ITT Population) 30 Days · Grade I:Mild Claudication (1)	7 Participants
Change of Rutherford Classification (ITT Population) 30 Days · Grade I:Severe Claudication (3)	1 Participants
Change of Rutherford Classification (ITT Population) 6 Months · Grade 0: Asymptomatic (0)	55 Participants
Change of Rutherford Classification (ITT Population) 6 Months · Grade I:Severe Claudication (3)	0 Participants
Change of Rutherford Classification (ITT Population) 6 Months · Grade I:Mild Claudication (1)	7 Participants
Change of Rutherford Classification (ITT Population) 6 Months · Grade II :Ischemic Rest Pain (4)	0 Participants
Change of Rutherford Classification (ITT Population) 6 Months · Grade III :Minor Tissue Loss (5)	2 Participants
Change of Rutherford Classification (ITT Population) 6 Months · Grade I:Moderate Claudication (2)	1 Participants

SECONDARY outcome

Timeframe: Baseline, 30 days and 6 months

Population: The mITT analysis set included all enrolled subjects who have been treated with the OAD on a target lesion that has met Independent Physician Review, regardless of deviations from the protocol.

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=66 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Change of Rutherford Classification (mITT Population) Baseline · Grade II :Ischemic Rest Pain (4)	8 Participants
Change of Rutherford Classification (mITT Population) Baseline · Grade I:Moderate Claudication (2)	19 Participants
Change of Rutherford Classification (mITT Population) Baseline · Grade III :Minor Tissue Loss (5)	0 Participants
Change of Rutherford Classification (mITT Population) Baseline · Grade I:Mild Claudication (1)	0 Participants
Change of Rutherford Classification (mITT Population) Baseline · Grade I:Severe Claudication (3)	39 Participants
Change of Rutherford Classification (mITT Population) 30 Days · Grade 0: Asymptomatic (0)	51 Participants
Change of Rutherford Classification (mITT Population) 30 Days · Grade I:Mild Claudication (1)	7 Participants
Change of Rutherford Classification (mITT Population) 30 Days · Grade III :Minor Tissue Loss (5)	0 Participants
Change of Rutherford Classification (mITT Population) 30 Days · Grade II :Ischemic Rest Pain (4)	0 Participants
Change of Rutherford Classification (mITT Population) 30 Days · Grade I:Severe Claudication (3)	1 Participants
Change of Rutherford Classification (mITT Population) 30 Days · Grade I:Moderate Claudication (2)	1 Participants
Change of Rutherford Classification (mITT Population) 6 Months · Grade 0: Asymptomatic (0)	54 Participants
Change of Rutherford Classification (mITT Population) 6 Months · Grade I:Moderate Claudication (2)	1 Participants
Change of Rutherford Classification (mITT Population) 6 Months · Grade III :Minor Tissue Loss (5)	2 Participants
Change of Rutherford Classification (mITT Population) 6 Months · Grade I:Severe Claudication (3)	0 Participants
Change of Rutherford Classification (mITT Population) Baseline · Grade 0: Asymptomatic (0)	0 Participants
Change of Rutherford Classification (mITT Population) 6 Months · Grade II :Ischemic Rest Pain (4)	0 Participants
Change of Rutherford Classification (mITT Population) 6 Months · Grade I:Mild Claudication (1)	7 Participants

SECONDARY outcome

Timeframe: Baseline (within 30 days of the clinical treatment), and Post Procedure (after the clinical trial treatment prior to discharge: post procedure ABI was collected on average 1.1 days post clinical trial treatment)

The Ankle-Brachial Index (ABI) is a simple, non-invasive test used to assess peripheral artery disease (PAD). It compares the blood pressure measured at the ankle with the blood pressure measured at the arm (brachial artery).

Outcome measures

Outcome measures
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 Participants Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Change in Ankle Brachial Index (ABI) Baseline mean ABI (ITT population)	0.76 ratio Standard Deviation 0.214
Change in Ankle Brachial Index (ABI) Post Procedure mean ABI (ITT population)	0.91 ratio Standard Deviation 0.178
Change in Ankle Brachial Index (ABI) Change in mean ABI (post-procedure - baseline)(ITT population)	0.15 ratio Standard Deviation 0.186
Change in Ankle Brachial Index (ABI) Baseline mean ABI (mITT population)	0.76 ratio Standard Deviation 0.213
Change in Ankle Brachial Index (ABI) Post Procedure mean ABI (mITT population)	0.91 ratio Standard Deviation 0.179
Change in Ankle Brachial Index (ABI) Change in mean ABI (post-procedure - baseline)(mITT population)	0.15 ratio Standard Deviation 0.187

Adverse Events

Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)]

Serious events: 27 serious events

Other events: 49 other events

Deaths: 0 deaths

Roll-in Cohort [Peripheral Orbital Atherectomy System(OAS)]

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 participants at risk Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™	Roll-in Cohort [Peripheral Orbital Atherectomy System(OAS)] n=14 participants at risk Roll-in subjects were initial cases by the investigator enrolled to ensure proper device training, and procedural and data collection adherence. Roll-in subjects were consented, treated, and followed per protocol. Roll-in subject data was reported and analyzed separately from the Analysis Cohort.
Blood and lymphatic system disorders Anemia	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
General disorders Cancer	1.5% 1/67 • Number of events 1 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
Cardiac disorders Cardiac dysfunction - Chronic heart failure or aggravated	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Infections and infestations New/worsening claudication	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Infections and infestations New/worsening gangrene	3.0% 2/67 • Number of events 2 • 6 months	0.00% 0/14 • 6 months
Infections and infestations New/worsening ulcer	4.5% 3/67 • Number of events 3 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Peripheral artery abrupt closure	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Peripheral artery pseudoaneurysm	1.5% 1/67 • Number of events 1 • 6 months	14.3% 2/14 • Number of events 2 • 6 months
Vascular disorders Peripheral artery restenosis	1.5% 1/67 • Number of events 2 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Peripheral artery stenosis	4.5% 3/67 • Number of events 3 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Peripheral artery vasospasm	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Infections and infestations Pneumonia	3.0% 2/67 • Number of events 2 • 6 months	0.00% 0/14 • 6 months
Nervous system disorders Spinal cord/nerve root disorders	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Other vascular disorder	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Infections and infestations Other infection- Localized	1.5% 1/67 • Number of events 1 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
General disorders Adverse event - Other	4.5% 3/67 • Number of events 3 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Perforation	1.5% 1/67 • Number of events 1 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
Vascular disorders Distal Emboli	13.4% 9/67 • Number of events 9 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Acute onset limb ischemia	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Dissection	0.00% 0/67 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
Blood and lymphatic system disorders Bleeding/hemorrhage, non access site	0.00% 0/67 • 6 months	7.1% 1/14 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure	Analysis Cohort[Peripheral Orbital Atherectomy System(OAS)] n=67 participants at risk Treatment with Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA) pre-dilation and Medtronic IN.PACT™ Admiral™ Drug Coated Balloon (DCB) Peripheral Orbital Atherectomy System (OAS): Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™	Roll-in Cohort [Peripheral Orbital Atherectomy System(OAS)] n=14 participants at risk Roll-in subjects were initial cases by the investigator enrolled to ensure proper device training, and procedural and data collection adherence. Roll-in subjects were consented, treated, and followed per protocol. Roll-in subject data was reported and analyzed separately from the Analysis Cohort.
Vascular disorders Peripheral artery slow flow	3.0% 2/67 • Number of events 2 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Peripheral artery vasospasm	3.0% 2/67 • Number of events 2 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
Renal and urinary disorders Hematuria	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Hypertension	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Peripheral artery abrupt closure	3.0% 2/67 • Number of events 2 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Peripheral artery stenosis	1.5% 1/67 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Vascular disorders Dissection	61.2% 41/67 • Number of events 41 • 6 months	64.3% 9/14 • Number of events 10 • 6 months
Vascular disorders Perforation	1.5% 1/67 • Number of events 1 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
Vascular disorders Distal Emboli	23.9% 16/67 • Number of events 16 • 6 months	14.3% 2/14 • Number of events 2 • 6 months
Immune system disorders Allergic reaction	0.00% 0/67 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
Gastrointestinal disorders Nausea/vomiting	0.00% 0/67 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
Vascular disorders Peripheral arteriovenous fistula	0.00% 0/67 • 6 months	7.1% 1/14 • Number of events 1 • 6 months

Additional Information

Ikuko Kishimoto, Principal Clinical Scientist

Abbott Vascular

Phone: 651.756.4878

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee * Site/investigator shall not divulge data or any other information disclosed by Sponsor or CRO in connection with this clinical study or information obtained as a result of this clinical trial to a third party without the prior written consent of Sponsor. * Site/investigator shall obtain the prior written consent of Sponsor before presenting any information obtained from this clinical trial to the professional academic society or other outside organization.
Publication restrictions are in place

Restriction type: OTHER