Trial Outcomes & Findings for The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia (NCT NCT03551496)

Last Updated: 2024-07-01

Results Overview

Twelve-Month Primary Patency defined as a binary endpoint to be determined via duplex ultrasound (DUS) measuring flow at the 12-month follow-up visit, in the absence of clinically-driven target lesion revascularization (TLR) or bypass of the target lesion. Data table consists of the number of participants with flow as assessed by DUS.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

201 participants

Primary outcome timeframe

12 months

Results posted on

2024-07-01

Participant Flow

Of 201 enrolled participants, 201 met inclusion criteria and were randomized. Phase 2 was not conducted.

Participant milestones

Participant milestones
Measure	DES BTK Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Overall Study STARTED	130	71
Overall Study COMPLETED	114	61
Overall Study NOT COMPLETED	16	10

Reasons for withdrawal

Reasons for withdrawal
Measure	DES BTK Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Overall Study Death	11	7
Overall Study Withdrawal by Subject	4	3
Overall Study Other Reasons	1	0

Baseline Characteristics

201 subjects analyzed; 44/201 subjects have a history of amputation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DES BTK n=130 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=71 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.	Total n=201 Participants Total of all reporting groups
Age, Customized Age (Year)	73.27 Years STANDARD_DEVIATION 9.61 • n=130 Participants	72.58 Years STANDARD_DEVIATION 10.14 • n=71 Participants	73.02 Years STANDARD_DEVIATION 9.78 • n=201 Participants
Sex: Female, Male Female	35 Participants n=130 Participants	16 Participants n=71 Participants	51 Participants n=201 Participants
Sex: Female, Male Male	95 Participants n=130 Participants	55 Participants n=71 Participants	150 Participants n=201 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	7 Participants n=130 Participants	4 Participants n=71 Participants	11 Participants n=201 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	69 Participants n=130 Participants	35 Participants n=71 Participants	104 Participants n=201 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	33 Participants n=130 Participants	18 Participants n=71 Participants	51 Participants n=201 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black, of African heritage	15 Participants n=130 Participants	10 Participants n=71 Participants	25 Participants n=201 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian or other Pacific Islander	0 Participants n=130 Participants	0 Participants n=71 Participants	0 Participants n=201 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaska Native	1 Participants n=130 Participants	1 Participants n=71 Participants	2 Participants n=201 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	2 Participants n=130 Participants	1 Participants n=71 Participants	3 Participants n=201 Participants
Race/Ethnicity, Customized Race/Ethnicity · Not Disclosed	3 Participants n=130 Participants	2 Participants n=71 Participants	5 Participants n=201 Participants
Region of Enrollment United States	80 Participants n=130 Participants	45 Participants n=71 Participants	125 Participants n=201 Participants
Region of Enrollment Japan	33 Participants n=130 Participants	17 Participants n=71 Participants	50 Participants n=201 Participants
Region of Enrollment Europe	17 Participants n=130 Participants	9 Participants n=71 Participants	26 Participants n=201 Participants
Smoking Current	27 Participants n=130 Participants	18 Participants n=71 Participants	45 Participants n=201 Participants
Smoking Never	36 Participants n=130 Participants	18 Participants n=71 Participants	54 Participants n=201 Participants
Smoking Previous	66 Participants n=130 Participants	35 Participants n=71 Participants	101 Participants n=201 Participants
Smoking Unknown	1 Participants n=130 Participants	0 Participants n=71 Participants	1 Participants n=201 Participants
Current Diabetes Mellitus	87 Participants n=130 Participants	47 Participants n=71 Participants	134 Participants n=201 Participants
History of Hyperlipidemia requiring medication	101 Participants n=130 Participants	52 Participants n=71 Participants	153 Participants n=201 Participants
History of Hypertension requiring medication	115 Participants n=130 Participants	59 Participants n=71 Participants	174 Participants n=201 Participants
History of Chronic Obstructive Pulmonary Disease	20 Participants n=130 Participants	9 Participants n=71 Participants	29 Participants n=201 Participants
Cardiac History History of Coronary Artery Disease	75 Participants n=130 Participants	40 Participants n=71 Participants	115 Participants n=201 Participants
Cardiac History History of Myocardial Infarction (MI)	29 Participants n=130 Participants	13 Participants n=71 Participants	42 Participants n=201 Participants
Cardiac History History of Congestive Heart Failure	30 Participants n=130 Participants	15 Participants n=71 Participants	45 Participants n=201 Participants
History of Percutaneous Coronary Intervention (PCI)	44 Participants n=130 Participants	22 Participants n=71 Participants	66 Participants n=201 Participants
History of Coronary Artery Bypass Graft (CABG) Surgery	31 Participants n=130 Participants	14 Participants n=71 Participants	45 Participants n=201 Participants
Current Anginal Status Stable Angina	22 Participants n=130 Participants	9 Participants n=71 Participants	31 Participants n=201 Participants
Current Anginal Status Unstable Angina	0 Participants n=130 Participants	0 Participants n=71 Participants	0 Participants n=201 Participants
Current Anginal Status None	108 Participants n=130 Participants	62 Participants n=71 Participants	170 Participants n=201 Participants
Current Anginal Status Unknown	0 Participants n=130 Participants	0 Participants n=71 Participants	0 Participants n=201 Participants
Neurologic/Renal History History of Transient Ischemic Attacks (TIA)	8 Participants n=130 Participants	3 Participants n=71 Participants	11 Participants n=201 Participants
Neurologic/Renal History History of Cerebrovascular Accident (CVA)	17 Participants n=130 Participants	11 Participants n=71 Participants	28 Participants n=201 Participants
Neurologic/Renal History History of Renal Insufficiency	23 Participants n=130 Participants	11 Participants n=71 Participants	34 Participants n=201 Participants
Neurologic/Renal History History of Renal Percutaneous Intervention	3 Participants n=130 Participants	0 Participants n=71 Participants	3 Participants n=201 Participants
History of amputation	28 Participants n=130 Participants	16 Participants n=71 Participants	44 Participants n=201 Participants
History of amputation - Limb treated Target Limb	10 Participants n=28 Participants • 201 subjects analyzed; 44/201 subjects have a history of amputation	4 Participants n=16 Participants • 201 subjects analyzed; 44/201 subjects have a history of amputation	14 Participants n=44 Participants • 201 subjects analyzed; 44/201 subjects have a history of amputation
History of amputation - Limb treated Non-Target Limb	16 Participants n=28 Participants • 201 subjects analyzed; 44/201 subjects have a history of amputation	9 Participants n=16 Participants • 201 subjects analyzed; 44/201 subjects have a history of amputation	25 Participants n=44 Participants • 201 subjects analyzed; 44/201 subjects have a history of amputation
History of amputation - Limb treated Both	2 Participants n=28 Participants • 201 subjects analyzed; 44/201 subjects have a history of amputation	3 Participants n=16 Participants • 201 subjects analyzed; 44/201 subjects have a history of amputation	5 Participants n=44 Participants • 201 subjects analyzed; 44/201 subjects have a history of amputation
History of amputation - Type of amputation Minor	23 Participants n=28 Participants • 44/201 subjects have a history of amputation	13 Participants n=16 Participants • 44/201 subjects have a history of amputation	36 Participants n=44 Participants • 44/201 subjects have a history of amputation
History of amputation - Type of amputation Major	6 Participants n=28 Participants • 44/201 subjects have a history of amputation	4 Participants n=16 Participants • 44/201 subjects have a history of amputation	10 Participants n=44 Participants • 44/201 subjects have a history of amputation
History of other peripheral vascular surgery	14 Participants n=130 Participants	11 Participants n=71 Participants	25 Participants n=201 Participants
History of other peripheral vascular surgery - Limb Treated Target Limb	4 Participants n=14 Participants • 25/201 subjects have a history of other peripheral vascular surgery	4 Participants n=11 Participants • 25/201 subjects have a history of other peripheral vascular surgery	8 Participants n=25 Participants • 25/201 subjects have a history of other peripheral vascular surgery
History of other peripheral vascular surgery - Limb Treated Non-Target Limb	9 Participants n=14 Participants • 25/201 subjects have a history of other peripheral vascular surgery	7 Participants n=11 Participants • 25/201 subjects have a history of other peripheral vascular surgery	16 Participants n=25 Participants • 25/201 subjects have a history of other peripheral vascular surgery
History of other peripheral vascular surgery - Limb Treated Both	1 Participants n=14 Participants • 25/201 subjects have a history of other peripheral vascular surgery	0 Participants n=11 Participants • 25/201 subjects have a history of other peripheral vascular surgery	1 Participants n=25 Participants • 25/201 subjects have a history of other peripheral vascular surgery
History of other peripheral endovascular interventions with non-paclitaxel containing devices	82 Participants n=130 Participants	37 Participants n=71 Participants	119 Participants n=201 Participants
History of other peripheral endovascular interventions with non-paclitaxel devices - Limb treated Target Limb	37 Participants n=82 Participants • 201 subjects analyzed; 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices	11 Participants n=37 Participants • 201 subjects analyzed; 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices	48 Participants n=119 Participants • 201 subjects analyzed; 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices
History of other peripheral endovascular interventions with non-paclitaxel devices - Limb treated Non-Target Limb	27 Participants n=82 Participants • 201 subjects analyzed; 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices	18 Participants n=37 Participants • 201 subjects analyzed; 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices	45 Participants n=119 Participants • 201 subjects analyzed; 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices
History of other peripheral endovascular interventions with non-paclitaxel devices - Limb treated Both	18 Participants n=82 Participants • 201 subjects analyzed; 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices	8 Participants n=37 Participants • 201 subjects analyzed; 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices	26 Participants n=119 Participants • 201 subjects analyzed; 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices
History of other peripheral endovascular with non-paclitaxel device-Type of most recent intervention Atherectomy	37 Participants n=82 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.	15 Participants n=37 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.	52 Participants n=119 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.
History of other peripheral endovascular with non-paclitaxel device-Type of most recent intervention Percutaneous Transluminal Angioplasty (PTA)	66 Participants n=82 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.	27 Participants n=37 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.	93 Participants n=119 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.
History of other peripheral endovascular with non-paclitaxel device-Type of most recent intervention Stenting	35 Participants n=82 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.	15 Participants n=37 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.	50 Participants n=119 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.
History of other peripheral endovascular with non-paclitaxel device-Type of most recent intervention Other	3 Participants n=82 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.	3 Participants n=37 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.	6 Participants n=119 Participants • 119/201 subjects have a history of other peripheral endovascular interventions with non-paclitaxel containing devices. Multiple subjects had various interventions.
History of interventions with paclitaxel-containing devices	59 Participants n=130 Participants	29 Participants n=71 Participants	88 Participants n=201 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	DES BTK n=103 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=50 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants With Primary Patency	70 Participants	38 Participants

PRIMARY outcome

Timeframe: 12 months

The primary safety endpoint assesses freedom from major adverse events (MAE) at 12 months post-procedure. (MAE is defined as: above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality)

Outcome measures

Outcome measures
Measure	DES BTK n=119 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=64 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants Free From Major Adverse Events (MAE)	109 Participants	61 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

Assisted primary patency defined as the percentage (%) of lesions without clinically-driven TLR and those with clinically-driven TLR (not due to complete occlusion or by-pass) which show flow by DUS without restenosis.

Outcome measures

Outcome measures
Measure	DES BTK n=91 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=44 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants With Assisted Primary Patency	75 Participants	41 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

Clinically-driven target lesion revascularization is defined as any surgical or percutaneous intervention to the target lesion after the index procedure if: 1. Occurring within 5mm proximal or distal to the original treatment segment with diameter stenosis ≥50% by quantitative angiography and if participant has recurrent symptoms OR 2. In-lesion diameter stenosis less than 50% might also be considered a MAE by the CEC if the subject has recurrent symptoms. Recurrent symptoms are defined as having ≥ 1 change in Rutherford Classification or associated with decreased ABI/TBI of ≥20% or ≥ 0.15 in the treated segment.

Outcome measures

Outcome measures
Measure	DES BTK n=128 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=67 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants With Clinically Driven Target Lesion Revascularization	21 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

Rates of amputation of the lower limb at the ankle level or above

Outcome measures

Outcome measures
Measure	DES BTK n=118 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=62 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants With Major Amputation (Defined as Amputation of the Lower Limb at the Ankle Level or Above)	3 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

The EQ-5D is a descriptive system of health-related quality-of-life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension). The levels are assigned a numeric code 1-5 (eg, 1= no problems and 5= extreme problems).

Outcome measures

Outcome measures
Measure	DES BTK n=99 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=53 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. Mobility Improvement	40 Participants	16 Participants
Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. Self-Care Improvement	19 Participants	8 Participants
Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. Usual Activities Improvement	32 Participants	17 Participants
Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. Pain/Discomfort Improvement	48 Participants	18 Participants
Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. Anxiety/Depression Improvement	28 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

Changes in quality of life is measured using the Vascular Quality of Life (VascuQol) questionnaire, which is a 25 item questionnaire used to measure the quality-of-life in patients with lower limb ischemia. The tool is sub-divided into 5 domains: pain, symptoms, activities, social and emotional.

Outcome measures

Outcome measures
Measure	DES BTK n=99 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=52 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in worried that I might injure my leg	42 Participants	21 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in ability to exercise or to play sports	56 Participants	21 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in legs felt tired or weak	55 Participants	26 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in restricted in spending time with friends or relatives	44 Participants	18 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in pain in the foot (or leg) after going to bed at night	58 Participants	31 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in pins and needles or numbness in leg (or foot) have caused	53 Participants	26 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in the distance I can walk has improved	39 Participants	17 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in ability to walk	59 Participants	25 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in being (or becoming) housebound has concerned	42 Participants	28 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in concerned about having poor circulation in legs	68 Participants	26 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in pain in the foot (or leg) when resting	67 Participants	31 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in ability to climb stairs	47 Participants	20 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in ability to participate in social activities	49 Participants	23 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in ability to do routine household work	54 Participants	22 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in ulcers or sores on my leg (or foot) caused pain or distress	45 Participants	15 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in pain in leg (or foot) when walking	61 Participants	27 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in cold feet have given	50 Participants	26 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in the range of activities that would have liked to do	58 Participants	26 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in problems caused by poor circulation made feel frustrated	60 Participants	29 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in pain in the leg (or foot) given	63 Participants	30 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in felt guilty about relying on friends or relatives	47 Participants	28 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in ability to go shopping or carry bags	50 Participants	21 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in worried in danger of losing a part of leg or foot	58 Participants	28 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in distance I can walk became less	48 Participants	25 Participants
Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. Improvement in depressed about the poor circulation in legs	57 Participants	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

Population: Data for baseline wounds assessed as healed are based on subjects with the data point collected.

Wounds assessed for healed status by Independent Wound Assessors, blinded to randomized treatment.

Outcome measures

Outcome measures
Measure	DES BTK n=79 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=32 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants With Baseline Wounds Assessed as Healed	34 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

Population: Data for Rate of Primary Sustained clinical Improvement as Assessed by Changes in Rutherford Classification from baseline are based on subjects with the data point collected

Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR. Rutherford Classifications: i. Category 0 - Asymptomatic ii. Category 1 - Mild claudication iii. Category 2 - Moderate claudication iv. Category 3 - Severe claudication v. Category 4 - Ischemic rest pain vi. Category 5 - Minor tissue loss - nonhealing ulcer, focal gangrene vii. Category 6 - Major tissue loss - extending above transmetatarsal (TM) level

Outcome measures

Outcome measures
Measure	DES BTK n=102 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=49 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline	80 Participants	36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

Population: The data presented in this table for the serious, non-serious, unanticipated, device-related, and procedure-related events are based on crude event rates, and the data used for the major events is based on the subjects evaluable for the primary safety endpoint.

Adverse events (AEs) to be classified as major (defined as above ankle amputation of the index limb, major re-intervention (new bypass graft, jump/interposition graft, or thrombectomy/thrombolysis) and perioperative (30 day) mortality), serious, non-serious, unanticipated, procedure-related and device-related.

Outcome measures

Outcome measures
Measure	DES BTK n=130 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=71 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants With Major, Serious, Non-serious, Unanticipated, Device-related and Procedure-related Adverse Events Non serious	84 Participants	37 Participants
Number of Participants With Major, Serious, Non-serious, Unanticipated, Device-related and Procedure-related Adverse Events Procedure-Related	21 Participants	16 Participants
Number of Participants With Major, Serious, Non-serious, Unanticipated, Device-related and Procedure-related Adverse Events Serious	82 Participants	51 Participants
Number of Participants With Major, Serious, Non-serious, Unanticipated, Device-related and Procedure-related Adverse Events Major	10 Participants	3 Participants
Number of Participants With Major, Serious, Non-serious, Unanticipated, Device-related and Procedure-related Adverse Events Unanticipated	0 Participants	0 Participants
Number of Participants With Major, Serious, Non-serious, Unanticipated, Device-related and Procedure-related Adverse Events Device-Related	16 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days post procedure

Hospitalizations related to Critical Limb Ischemia (CLI) due to target lesion revascularization (TLR)/target vessel revascularization (TVR) or Target Limb Major Amputation or Procedure/Device related Adverse Events

Outcome measures

Outcome measures
Measure	DES BTK n=130 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=71 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants Who Were Admitted to the Hospital Within 30 Days After the Index Procedure.	2 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post procedure

Population: Data for Hemodynamic Improvement are based on subjects with the data point collected.

Hemodynamic improvement is defined as improvement of ankle-brachial index (ABI) by ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure value without the need for repeat revascularization.

Outcome measures

Outcome measures
Measure	DES BTK n=91 Participants Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=49 Participants Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Number of Participants With Hemodynamic Improvement	59 Participants	28 Participants

Adverse Events

DES BTK

Serious events: 82 serious events

Other events: 84 other events

Deaths: 11 deaths

Conventional PTA

Serious events: 51 serious events

Other events: 37 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Dana Hromyak

Boston Scientific

Phone: 1 216-526-8534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	DES BTK n=130 participants at risk Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=71 participants at risk Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Vascular disorders Peripheral artery stenosis	9.2% 12/130 • Number of events 24 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	8.5% 6/71 • Number of events 10 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Peripheral artery occlusion	6.2% 8/130 • Number of events 17 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	7.0% 5/71 • Number of events 6 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Peripheral arterial occlusive disease	10.0% 13/130 • Number of events 16 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	8.5% 6/71 • Number of events 8 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Peripheral ischaemia	8.5% 11/130 • Number of events 14 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	7.0% 5/71 • Number of events 7 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Intermittent claudication	5.4% 7/130 • Number of events 10 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	4.2% 3/71 • Number of events 4 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Peripheral artery thrombosis	2.3% 3/130 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Hypotension	2.3% 3/130 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Arteriosclerosis	1.5% 2/130 • Number of events 2 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Extremity necrosis	0.77% 1/130 • Number of events 2 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Embolism arterial	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Hypertension	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Peripheral vascular disorder	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders Shock haemorrhagic	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Vascular disorders May-Thurner syndrome	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Osteomyelitis	7.7% 10/130 • Number of events 11 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	5.6% 4/71 • Number of events 4 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Gangrene	6.2% 8/130 • Number of events 9 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Pneumonia	4.6% 6/130 • Number of events 7 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	2.8% 2/71 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Cellulitis	3.1% 4/130 • Number of events 4 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	2.8% 2/71 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Urinary tract infection	2.3% 3/130 • Number of events 4 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Localised infection	2.3% 3/130 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	2.8% 2/71 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Sepsis	2.3% 3/130 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Influenza	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	2.8% 2/71 • Number of events 2 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Abscess limb	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Septic shock	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Wound infection	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Abscess	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Biliary sepsis	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Corona virus infection	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Device related sepsis	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Diabetic foot infection	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Endocarditis	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Enterococcal bacteraemia	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Osteomyelitis acute	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Scrotal abscess	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Staphylococcal sepsis	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Gas gangrene	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Herpes zoster	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Periodontitis	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Postoperative wound infection	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Subcutaneous abscess	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)

Other adverse events
Measure	DES BTK n=130 participants at risk Treatment with DES BTK Drug Eluting Stent - Below the Knee: Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm	Conventional PTA n=71 participants at risk Treatment with standard PTA Standard PTA Control Arm: The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
Infections and infestations Tinea infection	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Tinea pedis	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Tooth infection	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Wound abscess	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Conjunctivitis	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Dermatophytosis	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Influenza	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Viral pharyngitis	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Infections and infestations Wound infection staphylococcal	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Pain in extremity	4.6% 6/130 • Number of events 6 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	5.6% 4/71 • Number of events 5 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Back pain	4.6% 6/130 • Number of events 6 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	4.2% 3/71 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Arthralgia	2.3% 3/130 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Muscle spasms	2.3% 3/130 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Neck pain	1.5% 2/130 • Number of events 2 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Foot deformity	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Joint effusion	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Myalgia	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Musculoskeletal and connective tissue disorders Trigger finger	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Carotid artery disease	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Carotid artery stenosis	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Demyelinating Polyneuropathy	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Headache	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Myelopathy	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Neuralgia	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Presyncope	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Restless legs syndrome	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Cerebrovascular accident	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Nervous system disorders Neuropathy peripheral	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Acute kidney injury	2.3% 3/130 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	2.8% 2/71 • Number of events 2 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Dysuria	1.5% 2/130 • Number of events 2 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Pollakiuria	1.5% 2/130 • Number of events 2 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Anuria	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Costovertebral angle tenderness	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Renal cyst	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Renal impairment	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Urinary bladder haemorrhage	0.77% 1/130 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Haematuria	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Renal and urinary disorders Urinary tract pain	0.00% 0/130 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	1.4% 1/71 • Number of events 1 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 3/130 • Number of events 3 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)	0.00% 0/71 • Adverse event data collected through 12 months post-index procedure. All-cause mortality rate is through 12 month visit window (Day 395)