Trial Outcomes & Findings for The DETOUR 2 Clinical Trial (NCT NCT03119233)

NCT ID: NCT03119233

Last Updated: 2025-04-02

Results Overview

Primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR) ≤2.5 from DUS and no clinically-driven re-intervention within the stented segment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 202 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-04-02

Participant Flow

Enrollment in the DETOUR 2 study was completed on 05-October-2020. All eligible subjects completed the 30-day, follow-up visit, per the protocol. Compliance at the 6, 12, and 24-month follow-up visits was 95.5%, 91.9%, and 87.05%, respectively.

The DETOUR 2 study enrolled subjects at 32 US and 4 OUS sites 'All Subjects' (n=202 enrolled)

Participant milestones

Measure	Single Arm Intent to Treat (ITT) All Subjects This was a single arm study, Intent to Treat (ITT) includes all subjects enrolled in the IDE Study. ITT is the primary analysis population to determine if the primary safety endpoint was met in the study.
Overall Study STARTED	202
Overall Study COMPLETED	202
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lesion Length (Normal to Normal, mm) continuous variables presented as mean ± SD (N) where N is the number of subjects with available data.

Baseline characteristics by cohort

Measure	Single Arm Intention to Treat (ITT) All Subjects n=202 Participants This is a prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the PQ Bypass System, delivery guidewires, and implant stent grafts for percutaneous femoropopliteal bypass. The primary analysis population will include 202 subjects.
Age, Continuous	68.9 Years n=202 Participants
Sex: Female, Male Female	53 Participants n=202 Participants
Sex: Female, Male Male	149 Participants n=202 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=202 Participants
Race (NIH/OMB) Asian	0 Participants n=202 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants
Race (NIH/OMB) Black or African American	18 Participants n=202 Participants
Race (NIH/OMB) White	175 Participants n=202 Participants
Race (NIH/OMB) More than one race	2 Participants n=202 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=202 Participants
Region of Enrollment Latvia	26 participants n=202 Participants
Region of Enrollment United States	153 participants n=202 Participants
Region of Enrollment Germany	23 participants n=202 Participants
Rutherford clinical category Grade 3	157 Participants n=202 Participants
Rutherford clinical category Grade 4	36 Participants n=202 Participants
Rutherford clinical category Grade 5	9 Participants n=202 Participants
Renal Insufficiency	22 Participants n=202 Participants
History of Smoking Current/Previous	184 Participants n=202 Participants
History of Smoking Never	18 Participants n=202 Participants
Previous Peripheral Intervention	121 Participants n=202 Participants
History of Diabetes Type 1	1 Participants n=202 Participants
History of Diabetes Type 2	69 Participants n=202 Participants
Congestive Heart Failure	25 Participants n=202 Participants
Lesion Length	327.14 mm STANDARD_DEVIATION 61.376 • n=196 Participants • Lesion Length (Normal to Normal, mm) continuous variables presented as mean ± SD (N) where N is the number of subjects with available data.
Number of Run-Off Vessels 1	35 Participants n=187 Participants • N is the number of subjects with available data.
Number of Run-Off Vessels 2	129 Participants n=187 Participants • N is the number of subjects with available data.
Number of Run-Off Vessels 3	23 Participants n=187 Participants • N is the number of subjects with available data.

PRIMARY outcome

Timeframe: 12 months

Population: Number at Risk/Total Number of Events

Primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR) ≤2.5 from DUS and no clinically-driven re-intervention within the stented segment.

Outcome measures

Measure	All Subjects Intent to Treat (ITT) n=135 Participants Primary Patency: Kaplan Meier Estimates - All Subjects
Primary Patency	72.3 Percentage of Participants Interval 66.0 to 78.6

PRIMARY outcome

Timeframe: 30 days

Population: MAEs at 30 days

Freedom from a Major Adverse Event (MAE) at 30 days post-procedure (defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of(above the Treated Limb,ankle), Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery).

Outcome measures

Measure	All Subjects Intent to Treat (ITT) n=202 Participants Primary Patency: Kaplan Meier Estimates - All Subjects
Major Adverse Events at 30 Days MAE	14 Number of Events
Major Adverse Events at 30 Days Death	0 Number of Events
Major Adverse Events at 30 Days CD-TLR	0 Number of Events
Major Adverse Events at 30 Days Amputation of Treated Limb	0 Number of Events
Major Adverse Events at 30 Days Deep Vein Thrombosis (DVT)	5 Number of Events
Major Adverse Events at 30 Days Pulmonary Embolism (PE)	0 Number of Events
Major Adverse Events at 30 Days Procedure Related Bleeding	7 Number of Events

SECONDARY outcome

Timeframe: 30 Days

Stent graft separation and migration identified via ultrasound imaging

Outcome measures

Measure	All Subjects Intent to Treat (ITT) n=192 Participants Primary Patency: Kaplan Meier Estimates - All Subjects
Stent Graft Separation and Migration Stent Graft Separation	0 Number of Subjects Interval 0.0 to 1.9
Stent Graft Separation and Migration Stent Graft Migration	0 Number of Subjects Interval 0.0 to 1.9
Stent Graft Separation and Migration Stent Graft Separation or Migration	0 Number of Subjects Interval 0.0 to 1.9

SECONDARY outcome

Timeframe: 12 Months

Population: 12 Months

Stent graft separation and migration identified via X-ray

Outcome measures

Measure	All Subjects Intent to Treat (ITT) n=202 Participants Primary Patency: Kaplan Meier Estimates - All Subjects
Stent Graft Separation and Migration Via 12-Month X-Ray Stent Graft Separation	1 Number of Subjects with available data Interval 0.0 to 3.3
Stent Graft Separation and Migration Via 12-Month X-Ray Stent Graft Migration	3 Number of Subjects with available data Interval 0.4 to 5.1
Stent Graft Separation and Migration Via 12-Month X-Ray Stent Graft Separation or Migration	3 Number of Subjects with available data Interval 0.4 to 5.1

SECONDARY outcome

Timeframe: 12-Months

Population: Based on number of subjects with available data.

Stent graft fracture identified via X-ray

Outcome measures

Measure	All Subjects Intent to Treat (ITT) n=169 Participants Primary Patency: Kaplan Meier Estimates - All Subjects
Stent Graft Fracture Via 12-Month X-Ray	0 Number of Subjects Interval 0.0 to 2.2

Adverse Events

All Subjects

Serious events: 130 serious events

Other events: 142 other events

Deaths: 14 deaths

Serious adverse events

Measure	All Subjects n=202 participants at risk All Subjects Intent to Treat (ITT)
Blood and lymphatic system disorders Anaemia	3.5% 7/202 • Number of events 8 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Blood and lymphatic system disorders Iron deficiency anaemia	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Blood and lymphatic system disorders Lymphoma	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Blood and lymphatic system disorders Microcytic anaemia	0.50% 1/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Acute coronary syndrome	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Angina pectoris	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Angina unstable	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Arrhythmia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Arteriospasm coronary	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Atrial fibrillation	4.0% 8/202 • Number of events 10 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Atrial tachycardia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Cardiac arrest	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Cardiac failure	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Cardiac failure acute	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Cardiac failure congestive	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Coronary artery disease	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Coronary artery stenosis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Ischaemic cardiomyopathy	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders left ventricular failure	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Myocardial infarction	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Pulmonary oedema	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Sinus bradycardia	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Ventricular fibrillation	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Ventricular tachycardia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Endocrine disorders Diabetes mellitus inadequate control	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Endocrine disorders Diabetic foot	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Endocrine disorders Diabetic ketoacidosis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Endocrine disorders Hyperglycaemia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Endocrine disorders Hypoglycaemia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Diverticulitis	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Gastric ulcer	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Gastroenteritis viral	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.5% 5/202 • Number of events 6 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Haematemesis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Intestinal perforation	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Melaena	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Pyloric stenosis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Stomal hernia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Umbilical hernia	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Chest pain	0.99% 2/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Death	2.0% 4/202 • Number of events 4 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Oedema peripheral	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Organ failure	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Peripheral swelling	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Pyrexia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Vascular stent occlusion	0.50% 1/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Vascular stent stenosis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Hepatobiliary disorders Cholangitis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Infections and infestations Cellulitis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Infections and infestations Osteomyelitis	1.5% 3/202 • Number of events 4 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Infections and infestations Pneumonia	3.5% 7/202 • Number of events 7 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Infections and infestations Pneumonia viral	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Infections and infestations Postoperative wound infection	0.50% 1/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Infections and infestations Sepsis	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Infections and infestations Urinary tract infection	2.0% 4/202 • Number of events 4 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Infections and infestations Urosepsis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Infections and infestations Wound infection	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Anaemia postoperative	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Atheroembolism	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Burns second degree	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Craniocerebral injury	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Fall	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Femoral artery peforation	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Femur fracture	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Post procedural haematoma	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Procedural hypotension	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Respiratory fume inhalation disorder	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Rib fracture	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Stoma complication	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Tibia fracture	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Vascular access site maematoma	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Wound dehiscence	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Wound secretion	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Investigations Transaminases increased	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Investigations Troponin increased	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Investigations Ultrasound Doppler abnormal	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Metabolism and nutrition disorders Acute respiratory failure	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Metabolism and nutrition disorders Dehydration	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Metabolism and nutrition disorders Hyperinsulinaemic hypoglycaemia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Metabolism and nutrition disorders Hypocalcaemia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Metabolism and nutrition disorders Hypokalaemia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Metabolism and nutrition disorders Hypomagnesaemia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Humerus fracture	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Muscle spasms	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 5/202 • Number of events 5 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Pelvic fracture	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Spinal compression fracture	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Upper limb fracture	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenomatous polyposis coli	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dermal cyst	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Nervous system disorders Cerebellar stroke	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Nervous system disorders Cerebrovascular accident	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Nervous system disorders Headache	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Nervous system disorders Syncope	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Nervous system disorders Thoracic spinal stenosis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Nervous system disorders Thrombotic stroke	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Nervous system disorders Transient ischaemic attack	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Product Issues Device dislocation	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Product Issues Device malfunction	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Renal and urinary disorders Acute kidney injury	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Renal and urinary disorders Renal failure	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Respiratory, thoracic and mediastinal disorders Respiratory tract infection	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Surgical and medical procedures Angioplasty	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Surgical and medical procedures Toe amputation	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Anaphylactic shock	0.50% 1/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Aortic aneurysm	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Arterial bypass stenosis	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Arterial occlusive disease	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Arterial stenosis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Arteriovenous fistula	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Carotid artery stenosis	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Cerebellar haemorrhage	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Circulatory collapse	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Compartment syndrome	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Deep vein thrombosis	4.0% 8/202 • Number of events 9 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Device embolisation	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Femoral artery dissection	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Femoral artery embolism	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Gastrointestinal haemorrhage	0.99% 2/202 • Number of events 2 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Haematoma	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Haemorrhage intracranial	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Hypertension	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Hypertensive crisis	0.50% 1/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Hypertensive emergency	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Hypotension	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Hypovolaemic shock	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Intermittent claudication	5.4% 11/202 • Number of events 13 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Ischaemic limb pain	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Pelvic haemorrhage	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral arterial occlusive disease	3.0% 6/202 • Number of events 6 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral artery aneurysm	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral artery haematoma	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral artery occlusion	4.5% 9/202 • Number of events 10 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral artery restenosis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral artery stenosis	6.9% 14/202 • Number of events 17 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral artery thrombosis	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral embolism	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral ischaemia	4.5% 9/202 • Number of events 12 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral vascular disorder	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Pharyngeal haemorrhage	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Retroperitoneal haematoma	0.50% 1/202 • Number of events 1 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Vascular stent occlusion	12.9% 26/202 • Number of events 31 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Vascular stent stenosis	5.4% 11/202 • Number of events 11 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Vascular stent thrombosis	1.5% 3/202 • Number of events 3 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Acute myocardial infarction	2.0% 4/202 • Number of events 4 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.

Other adverse events

Measure	All Subjects n=202 participants at risk All Subjects Intent to Treat (ITT)
Blood and lymphatic system disorders Anaemia	4.0% 8/202 • Number of events 9 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Cardiac disorders Atrial Fibrillation	3.0% 6/202 • Number of events 6 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Oedema peripheral	5.0% 10/202 • Number of events 10 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
General disorders Peripheral swelling	5.4% 11/202 • Number of events 11 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Injury, poisoning and procedural complications Vascular access site haemorrhage	5.0% 10/202 • Number of events 10 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Musculoskeletal and connective tissue disorders Pain in extremity	8.9% 18/202 • Number of events 20 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Deep vein thrombosis	13.4% 27/202 • Number of events 29 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Hypertension	4.0% 8/202 • Number of events 8 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral venous disease	3.0% 6/202 • Number of events 8 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Vascular stent occlusion	5.4% 11/202 • Number of events 11 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Vascular stent stenosis	5.0% 10/202 • Number of events 11 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Vascular disorders Peripheral artery stenosis	8.4% 17/202 • Number of events 20 • All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.

Additional Information

Tammy Stiver, Manager, Clinical Affairs

Endologix

Phone: 5136731452

Email: tstiver@endologix.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER