RANGER II SFA: RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03064126
Collaborator
(none)
440
67
2
78
6.6
0.1

Study Details

Study Description

Brief Summary

To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).

Long Balloon substudy: To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

Condition or Disease Intervention/Treatment Phase
  • Device: RANGER™ Paclitaxel Coated Balloon
  • Drug: Paclitaxel
  • Procedure: Standard Balloon Angioplasty
Phase 3

Detailed Description

The RANGER II SFA is a global, prospective, multi-center clinical trial. Approximately 446 subjects will be enrolled at up to 80 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand.

The trial consists of a single-blind, superiority, 3:1 (Ranger DCB vs. Standard PTA) randomized controlled trial (RCT) and a concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy, and a concurrent, non-blinded, non-randomized, Long balloon substudy.

Study Design

Study Type:
Interventional
Actual Enrollment :
440 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The RANGER™ investigational device is coated with the drug paclitaxel.The RANGER™ investigational device is coated with the drug paclitaxel.
Masking:
Single (Participant)
Masking Description:
Subjects will be blinded to treatment assigned and treatment received until completion of all 12 month follow-up visits (primary endpoint).
Primary Purpose:
Treatment
Official Title:
RANGER II SFA: A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA)
Actual Study Start Date :
Mar 2, 2017
Actual Primary Completion Date :
Nov 18, 2019
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: RANGER™ Paclitaxel Coated Balloon

RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.

Device: RANGER™ Paclitaxel Coated Balloon
A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.
Other Names:
  • Percutaneous Transluminal Angioplasty (PTA)
  • Drug: Paclitaxel
    The RANGER™ Balloon is coated with the drug Paclitaxel.

    Active Comparator: Standard Balloon Angioplasty

    Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.

    Procedure: Standard Balloon Angioplasty
    A procedure that utilizes an uncoated balloon which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.
    Other Names:
  • Percutaneous Transluminal Angioplasty (PTA)
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Primary Lesion Patency [12 months (6 months for LB substudy)]

      RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR >2.4 suggests >50% stenosis. LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure. PK Substudy not analyzed for primary patency.

    2. Major Adverse Events (MAEs) (Primary Safety Endpoint) [12 months (6 months for LB substudy)]

      RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months. LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure. PK Substudy: Not analyzed for primary safety endpoint.

    Secondary Outcome Measures

    1. Number of Participants With Technical Success of Angioplasty Procedure [Day 0]

      Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure.

    2. Number of Participants With Procedural Success of Angioplasty Procedure [Day 0]

      Procedural success defined as residual stenosis of less than or equal to 50% (non-stented subjects) or less than or equal to 30% (stented subjects) by core laboratory evaluation.

    3. Number of Participants With Clinical Success Rate Assessment [Day 0]

      Clinical success defined as procedural success without procedural complications including death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR prior to discharge.

    4. Number of Major Adverse Event (MAE) Assessment [12 months (6 months for LB substudy)]

      MAEs defined as all-cause of death post-index procedure, target limb major amputation, and/or target lesion revascularization (TLR).

    5. Number of CEC Adjudicated Events Through 12 Months [12 months (6 Months for LB Substudy)]

      Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window.

    6. Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline [12 months (6 months for LB substudy)]

      Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR

    7. Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification [12 months (6 months for LB substudy)]

      Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR

    8. Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) [12 months (6 months for LB substudy)]

      Improvement of ABI by ≥ 0.1 or to an ABI ≥ 0.90 as compared to the pre-procedure value without the need for repeat revascularization.

    9. Walking Improvement (Distance) Assessed by Change in Six Minute Walk Test (6MWT) [12 months]

      The 6MWT measure the maximal walking distance that a patient achieves on a flat, hard surface within a period of 6 minutes. It evaluates the global and integrated responses of all physiological systems involved during exercise including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, neuromuscular units and muscle metabolism. Change in distance walked from baseline to 12 months.

    10. Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline [12 months]

      The WIQ is a functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability. It also assesses the reasons that walking ability might be limited. Range of scores include 0% (worst score) to 100% (best score). Walking improvement change assessed from baseline to 12 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits;

    2. Subject at least 20 years of age;

    3. Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4;

    4. Target lesion is in the native SFA and/or PPA down to the P1 segment;

    5. Patent popliteal and infrapopliteal arteries, i.e., single vessel runoff or better with at least one of three vessels patent (less than 50 % stenosis) to the ankle or foot;

    6. Reference vessel diameter ≥ 4 mm and ≤ 8 mm by visual estimate;

    7. Angiographic evidence that target lesion consists of a single de novo, non-stented and non-atherectomy treated or restenotic lesion (or tandem lesions or a combination lesion as defined below) that is:

    • ≥ 70%-99% stenotic with total lesion length up to 180 mm by visual estimate.

    • Occluded with total lesion length ≤ 100 mm by visual estimate.

    • If lesion is restenotic, most recent PTA treatment must be > 3 months prior to enrollment.

    Exclusion Criteria:
    1. Life expectancy, documented in the Investigator's opinion, of less than 12 months;

    2. Hemorrhagic stroke or cardiac event (e.g. STEMI, unstable angina) within 6 months prior to enrollment;

    3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;

    4. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated;

    5. Chronic renal insufficiency with serum creatinine > 2.0 mg/dL within 30 days of index procedure or treatment with dialysis;

    6. Platelet count < 80,000 mm 3 or > 600,000 mm 3 or history of bleeding diathesis;

    7. Receiving immunosuppressive therapy;

    8. Septicemia at the time of enrollment;

    9. Any major intervention planned within 30 days post index procedure;

    10. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of enrollment;

    11. Failure to successfully cross the target lesion with a guidewire;

    12. Failure to successfully pre-dilate the target vessel;

    13. Patient has lesion that requires the use of adjunctive primary treatment modalities (i.e. laser, atherectomy, scoring/cutting balloon, other debulking devices, etc.) during the index procedure;

    14. History of major amputation in the target limb;

    15. Target lesion or vessel has ever been previously treated with stent (e.g. in-stent restenosis) or surgery. Target lesion or vessel has been treated with atherectomy or a DCB in the past 12 months;

    16. Pregnant or breast feeding;

    17. Presence of aneurysm in the target vessel;

    18. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment;

    19. Patient has significant inflow disease which cannot be treated prior to the target lesion treatment;

    20. Patient has perforated targeted vessel as evidenced by extravasation of contrast media;

    21. Patient has severe calcification that renders the lesion undilatable;

    22. Current participation in another investigational drug or device clinical trial that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current trial endpoints.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Hospital Fairhope Alabama United States 36532
    2 Rocky Mountain Regional VA Medical Center Aurora Colorado United States 80045
    3 The Vascular Experts Stratford Connecticut United States 06612
    4 Christiana Hospital Newark Delaware United States 19718
    5 Washington Hospital Center Washington District of Columbia United States 20010
    6 South Florida Vascular Associates Coconut Creek Florida United States 33073
    7 North Florida Regional Medical Center Gainesville Florida United States 32605
    8 Mount Sinai Medical Center Miami Beach Florida United States 33140
    9 AdventHealth Orlando Orlando Florida United States 32803
    10 AdventHealth Sebring Sebring Florida United States 33872
    11 Wellstar Hospitals Marietta Georgia United States 30060
    12 Kaiser Foundation Hospitals Honolulu Hawaii United States 96819
    13 St. Joseph Hospital Fort Wayne Indiana United States 46802
    14 Community Hospital Munster Indiana United States 46321
    15 King's Daughters Medical Center - Kentucky Heart Institute Ashland Kentucky United States 41101
    16 Terrebonne General Medical Center Houma Louisiana United States 70360
    17 Mercy Hospital Coon Rapids Minnesota United States 55433
    18 United Heart and Vascular Clinic Saint Paul Minnesota United States 55102
    19 Hackensack University Medical Center Hackensack New Jersey United States 07601
    20 Jersey Shore University Medical Center Neptune New Jersey United States 07753
    21 Mount Sinai Medical Center New York New York United States 10029
    22 Staten Island University Hospital Staten Island New York United States 10305
    23 Rex Hospital Raleigh North Carolina United States 27607
    24 Coastal Carolina Surgical Associates Wilmington North Carolina United States 28401
    25 Bethesda North Hospital Cincinnati Ohio United States 45220
    26 Ohio State University Medical Center Columbus Ohio United States 20161
    27 Premier Cardiovascular Institute Dayton Ohio United States 45406
    28 Northeast Ohio Vascular Associates, Inc. Willoughby Ohio United States 44094
    29 St. Charles Medical Center Bend Oregon United States 97701
    30 Temple University Philadelphia Pennsylvania United States 19140
    31 University Medical Center-Greenville Memorial Hospital Greenville South Carolina United States 29605
    32 Turkey Creek Medical Center Knoxville Tennessee United States 37934
    33 North Park Heart & Vascular Center Dallas Texas United States 75321
    34 Cardiology Clinic of San Antonio Live Oak Texas United States 78233
    35 Texas Tech University Health Sciences Center Lubbock Texas United States 79430
    36 North Dallas Research Associates McKinney Texas United States 75069
    37 The Heart Hospital Baylor Plano Plano Texas United States 75093
    38 THR Presbyterian Plano Plano Texas United States 75093
    39 Tyler Cardiac and Endovascular Center Tyler Texas United States 75701
    40 Davis Hospital and Medical Center Layton Utah United States 84041
    41 West Virginia University Hospitals Morgantown West Virginia United States 26506
    42 Aspirus Heart and Vascular Institute Wausau Wisconsin United States 54401
    43 Medizinische Univ.-Kliniken Graz Graz Austria 8036
    44 Allgemeines Krankenhaus AKH Vienna Austria 1090
    45 Hanusch-Krankenhaus Vienna Austria 1140
    46 Ziekenhuis Oost Limburg Genk Belgium 3600
    47 Universitair Ziekenhuis Gent Gent Belgium 9000
    48 Regionaal Ziekenhuis Heilig Hart Tienen Tienen Belgium 3300
    49 Peter Lougheed Centre Calgary Alberta Canada T1Y 6J4
    50 Hamilton General Hospital Hamilton Ontario Canada L8L 2X2
    51 Fleurimont Hospital Sherbrooke Quebec Canada J1H 5N4
    52 Hopital Saint - Francois d'Assise Quebec Canada G1L 3L2
    53 Kokura Memorial Hospital Kitakyushu Fukuoka Japan
    54 Iwaki City Medical Center Iwaki Fukushima Japan
    55 Tokeidai Memorial Hospital Sapporo Hokkaido Japan
    56 Kansai Rosai Hospital Amagasaki Hyogo-ken Japan
    57 Saiseikai Yokohama-City Eastern Hospital Yokohama Kanagawa Japan
    58 Sendai Kousei Hospital Sendai Miyagi Japan
    59 Kishiwada Tokushukai Hospital Kishiwada Osaka Japan
    60 Kasukabe Chuo General Hospital Kasukabe Saitama Japan
    61 Saiseikai Central Hospital Minato Tokyo Japan
    62 Kyoto Katsura Hospital Kyoto Japan
    63 Morinomiya Hospital Osaka Japan
    64 Osaka Saiseikai Nakatsu Hospital Osaka Japan
    65 Auckland City Hospital Auckland New Zealand 1010
    66 Clinical Trials NZ Hamilton New Zealand 3204
    67 Middlemore Hospital Otahuhu New Zealand 1640

    Sponsors and Collaborators

    • Boston Scientific Corporation

    Investigators

    • Principal Investigator: Thomas Zeller, MD, Universitaets-Herzzentrum
    • Principal Investigator: Ravish Sachar, MD, University of North Carolina - Rex Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT03064126
    Other Study ID Numbers:
    • S2062
    First Posted:
    Feb 24, 2017
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Boston Scientific Corporation
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 440 subjects were enrolled in the trial (376 subjects in the RCT, 52 subjects in the LB substudy and 12 subjects in the PK substudy). RCT subjects were randomized to Ranger DCB or standard PTA at a 3:1 ratio, respectively. All LB and PK subjects were treated with the Ranger DCB. RCT/PK shows 12 months data; LB shows 6 month data.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon. RANGER™ Paclitaxel Coated Balloon: A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries. Paclitaxel: The RANGER™ Balloon is coated with the drug Paclitaxel. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon. Standard Balloon Angioplasty: A procedure that utilizes an uncoated balloon which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
    Period Title: Overall Study
    STARTED 278 98 52 12
    COMPLETED 252 91 49 11
    NOT COMPLETED 26 7 3 1

    Baseline Characteristics

    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy Total
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure. Total of all reporting groups
    Overall Participants 278 98 52 12 440
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    70.6
    (9.5)
    69.1
    (10.3)
    70.3
    (9.9)
    63.3
    (13.3)
    70.06
    (9.87)
    Sex: Female, Male (Count of Participants)
    Female
    105
    37.8%
    31
    31.6%
    14
    26.9%
    8
    66.7%
    158
    35.9%
    Male
    173
    62.2%
    67
    68.4%
    38
    73.1%
    4
    33.3%
    282
    64.1%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    21
    7.6%
    8
    8.2%
    0
    0%
    0
    0%
    29
    6.6%
    Caucasian
    155
    55.8%
    59
    60.2%
    51
    98.1%
    9
    75%
    274
    62.3%
    Asian (Japanese)
    77
    27.7%
    25
    25.5%
    0
    0%
    0
    0%
    102
    23.2%
    Black, or African Heritage
    20
    7.2%
    4
    4.1%
    1
    1.9%
    3
    25%
    28
    6.4%
    Native Hawaiian or other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    American Indian or Alaska Native
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    1
    0.2%
    Other
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    1
    0.2%
    Not Disclosed
    3
    1.1%
    2
    2%
    0
    0%
    0
    0%
    5
    1.1%
    Region of Enrollment (participants) [Number]
    New Zealand
    7
    2.5%
    2
    2%
    2
    3.8%
    0
    0%
    11
    2.5%
    Canada
    12
    4.3%
    4
    4.1%
    0
    0%
    0
    0%
    16
    3.6%
    Europe
    29
    10.4%
    8
    8.2%
    50
    96.2%
    0
    0%
    87
    19.8%
    Japan
    77
    27.7%
    25
    25.5%
    0
    0%
    0
    0%
    102
    23.2%
    United States
    153
    55%
    59
    60.2%
    0
    0%
    12
    100%
    224
    50.9%
    History of Smoking (Current) (Count of Participants)
    Count of Participants [Participants]
    87
    31.3%
    45
    45.9%
    24
    46.2%
    6
    50%
    162
    36.8%
    History of Smoking (Previous) (Count of Participants)
    Count of Participants [Participants]
    150
    54%
    38
    38.8%
    23
    44.2%
    5
    41.7%
    216
    49.1%
    History of Smoking (Never) (Count of Participants)
    Count of Participants [Participants]
    40
    14.4%
    15
    15.3%
    5
    9.6%
    1
    8.3%
    61
    13.9%
    History of Smoking (Unknown) (Count of Participants)
    Count of Participants [Participants]
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    1
    0.2%
    Current Diabetes Mellitus (Count of Participants)
    Count of Participants [Participants]
    118
    42.4%
    43
    43.9%
    17
    32.7%
    8
    66.7%
    186
    42.3%
    History of Hyperlipidemia requiring medication (Count of Participants)
    Count of Participants [Participants]
    211
    75.9%
    78
    79.6%
    42
    80.8%
    10
    83.3%
    341
    77.5%
    History of Hypertension requiring medication (Count of Participants)
    Count of Participants [Participants]
    251
    90.3%
    80
    81.6%
    37
    71.2%
    9
    75%
    377
    85.7%
    History of Chronic Obstructive Pulmonary Disease (Count of Participants)
    Count of Participants [Participants]
    52
    18.7%
    21
    21.4%
    9
    17.3%
    2
    16.7%
    84
    19.1%
    History of Coronary Artery Disease (CAD) (Count of Participants)
    Count of Participants [Participants]
    131
    47.1%
    44
    44.9%
    14
    26.9%
    7
    58.3%
    196
    44.5%
    History of Myocardial Infarction (MI) (Count of Participants)
    Count of Participants [Participants]
    46
    16.5%
    14
    14.3%
    6
    11.5%
    4
    33.3%
    70
    15.9%
    History of Congestive Heart Failure (CHF) (Count of Participants)
    Count of Participants [Participants]
    26
    9.4%
    9
    9.2%
    1
    1.9%
    0
    0%
    36
    8.2%
    NYHA Classification (Count of Participants)
    NYHA I Classification
    10
    3.6%
    0
    0%
    0
    0%
    10
    83.3%
    NYHA II Classification
    6
    2.2%
    6
    6.1%
    0
    0%
    12
    100%
    NYHA III Classification
    1
    0.4%
    0
    0%
    0
    0%
    1
    8.3%
    NYHA IV Classification
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NYHA Unknown Classification
    9
    3.2%
    3
    3.1%
    1
    1.9%
    13
    108.3%
    History of Percutaneous Coronary Intervention (PCI) (Count of Participants)
    Count of Participants [Participants]
    81
    29.1%
    34
    34.7%
    8
    15.4%
    2
    16.7%
    125
    28.4%
    History of Coronary Artery Bypass Graft (CABG) Surgery (Count of Participants)
    Count of Participants [Participants]
    35
    12.6%
    15
    15.3%
    1
    1.9%
    1
    8.3%
    52
    11.8%
    Stable Angina (Count of Participants)
    Count of Participants [Participants]
    35
    12.6%
    13
    13.3%
    1
    1.9%
    0
    0%
    49
    11.1%
    Unstable Angina (Count of Participants)
    Count of Participants [Participants]
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    1
    0.2%
    No Angina (Count of Participants)
    Count of Participants [Participants]
    242
    87.1%
    85
    86.7%
    50
    96.2%
    12
    100%
    389
    88.4%
    Angina (Unknown) (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    0
    0%
    1
    1.9%
    0
    0%
    1
    0.2%
    History of Transient Ischemic Attacks (TIA) (Count of Participants)
    Count of Participants [Participants]
    14
    5%
    7
    7.1%
    5
    9.6%
    0
    0%
    26
    5.9%
    History of Cerebrovascular Accident (CVA) (Count of Participants)
    Count of Participants [Participants]
    36
    12.9%
    11
    11.2%
    2
    3.8%
    2
    16.7%
    51
    11.6%
    History of Renal Insufficiency (Count of Participants)
    Count of Participants [Participants]
    30
    10.8%
    5
    5.1%
    6
    11.5%
    3
    25%
    44
    10%
    History of Renal Percutaneous Intervention (Count of Participants)
    Count of Participants [Participants]
    6
    2.2%
    1
    1%
    0
    0%
    0
    0%
    7
    1.6%
    History of Peripheral Vascular Surgery (Count of Participants)
    Count of Participants [Participants]
    24
    8.6%
    9
    9.2%
    8
    15.4%
    0
    0%
    41
    9.3%
    History of Endovascular Interventions (Count of Participants)
    Count of Participants [Participants]
    131
    47.1%
    47
    48%
    23
    44.2%
    4
    33.3%
    205
    46.6%
    History of Claudication (Count of Participants)
    Count of Participants [Participants]
    271
    97.5%
    90
    91.8%
    50
    96.2%
    12
    100%
    423
    96.1%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Primary Lesion Patency
    Description RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR >2.4 suggests >50% stenosis. LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure. PK Substudy not analyzed for primary patency.
    Time Frame 12 months (6 months for LB substudy)

    Outcome Measure Data

    Analysis Population Description
    Percentage (%) of lesions that reach endpoint without a hemodynamically significant stenosis on DUS and without clinically-driven TLR or bypass of the target lesion. PK Substudy not analyzed for primary patency.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. Primary safety and effectiveness endpoints for the LB Substudy are assessed at 6 months post-procedure. The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
    Measure Participants 234 86 46 0
    Count of Participants [Participants]
    194
    69.8%
    57
    58.2%
    43
    82.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RANGER™ Paclitaxel Coated Balloon RCT, Standard Balloon Angioplasty RCT
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.166
    Confidence Interval (1-Sided) 97.5%
    0.0553 to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Major Adverse Events (MAEs) (Primary Safety Endpoint)
    Description RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months. LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure. PK Substudy: Not analyzed for primary safety endpoint.
    Time Frame 12 months (6 months for LB substudy)

    Outcome Measure Data

    Analysis Population Description
    PK Substudy not analyzed for primary safety endpoint.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. Primary safety and effectiveness endpoints for the LB Substudy are assessed at 6 months post-procedure. The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
    Measure Participants 256 91 51 0
    Count of Participants [Participants]
    241
    86.7%
    76
    77.6%
    50
    96.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RANGER™ Paclitaxel Coated Balloon RCT, Standard Balloon Angioplasty RCT
    Comments
    Type of Statistical Test Non-Inferiority
    Comments A Chi-Square Test was used to assess the hypothesis for the difference in 12-month MAE-free rate with non-inferiority margin (-10%).
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Chi-squared
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 0.106
    Confidence Interval (1-Sided) 97.5%
    0.0248 to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Number of Participants With Technical Success of Angioplasty Procedure
    Description Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure.
    Time Frame Day 0

    Outcome Measure Data

    Analysis Population Description
    RCT: Device deficiency data is only collected for Ranger DCB; not collected for Standard PTA group.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
    Measure Participants 278 0 52 12
    Count of Participants [Participants]
    277
    99.6%
    47
    48%
    12
    23.1%
    4. Secondary Outcome
    Title Number of Participants With Procedural Success of Angioplasty Procedure
    Description Procedural success defined as residual stenosis of less than or equal to 50% (non-stented subjects) or less than or equal to 30% (stented subjects) by core laboratory evaluation.
    Time Frame Day 0

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
    Measure Participants 278 98 52 12
    Count of Participants [Participants]
    269
    96.8%
    97
    99%
    49
    94.2%
    12
    100%
    5. Secondary Outcome
    Title Number of Participants With Clinical Success Rate Assessment
    Description Clinical success defined as procedural success without procedural complications including death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR prior to discharge.
    Time Frame Day 0

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
    Measure Participants 278 98 52 12
    Count of Participants [Participants]
    267
    96%
    96
    98%
    48
    92.3%
    11
    91.7%
    6. Secondary Outcome
    Title Number of Major Adverse Event (MAE) Assessment
    Description MAEs defined as all-cause of death post-index procedure, target limb major amputation, and/or target lesion revascularization (TLR).
    Time Frame 12 months (6 months for LB substudy)

    Outcome Measure Data

    Analysis Population Description
    MAE assessment rates are based on number of evaluable subjects - subjects with the data point collected.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
    Measure Participants 278 98 52
    All Cause Death
    5
    1.8%
    2
    2%
    2
    3.8%
    Target Lesion Revascularization
    14
    5%
    15
    15.3%
    1
    1.9%
    Major Target Limb Amputation
    0
    0%
    0
    0%
    0
    0%
    7. Secondary Outcome
    Title Number of CEC Adjudicated Events Through 12 Months
    Description Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window.
    Time Frame 12 months (6 Months for LB Substudy)

    Outcome Measure Data

    Analysis Population Description
    Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
    Measure Participants 278 98 52
    All Deaths
    5
    1.8%
    2
    2%
    2
    3.8%
    All Target Lesion Revascularization (TLR)
    14
    5%
    15
    15.3%
    1
    1.9%
    All Target Vessel Revascularization (TVR)
    16
    5.8%
    15
    15.3%
    1
    1.9%
    All Target Limb Amputation
    1
    0.4%
    0
    0%
    0
    0%
    8. Secondary Outcome
    Title Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline
    Description Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR
    Time Frame 12 months (6 months for LB substudy)

    Outcome Measure Data

    Analysis Population Description
    Primary sustained clinical improvement rates are based on number of evaluable subjects - subjects with the data point collected.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
    Measure Participants 251 91 49
    Count of Participants [Participants]
    220
    79.1%
    69
    70.4%
    48
    92.3%
    9. Secondary Outcome
    Title Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification
    Description Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR
    Time Frame 12 months (6 months for LB substudy)

    Outcome Measure Data

    Analysis Population Description
    Secondary sustained clinical improvement rates are based on number of evaluable subjects - subjects with the data point collected.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
    Measure Participants 251 91 49
    Count of Participants [Participants]
    230
    82.7%
    81
    82.7%
    48
    92.3%
    10. Secondary Outcome
    Title Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI)
    Description Improvement of ABI by ≥ 0.1 or to an ABI ≥ 0.90 as compared to the pre-procedure value without the need for repeat revascularization.
    Time Frame 12 months (6 months for LB substudy)

    Outcome Measure Data

    Analysis Population Description
    Hemodynamic improvement rates are based on number of evaluable subjects - subjects with the data point collected.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT Long Balloon (LB) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions.
    Measure Participants 250 84 45
    Count of Participants [Participants]
    200
    71.9%
    57
    58.2%
    43
    82.7%
    11. Secondary Outcome
    Title Walking Improvement (Distance) Assessed by Change in Six Minute Walk Test (6MWT)
    Description The 6MWT measure the maximal walking distance that a patient achieves on a flat, hard surface within a period of 6 minutes. It evaluates the global and integrated responses of all physiological systems involved during exercise including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, neuromuscular units and muscle metabolism. Change in distance walked from baseline to 12 months.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Data provided is total distance walked (m) change from baseline. Walking Improvement (distance) assessed by change in Six Minute Walk Test (6MWT) is based on number of evaluable subjects - subjects with data point collected.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
    Measure Participants 235 88
    Mean (Standard Deviation) [Meters]
    36.3
    (162.2)
    46.1
    (115.4)
    12. Secondary Outcome
    Title Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline
    Description The WIQ is a functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability. It also assesses the reasons that walking ability might be limited. Range of scores include 0% (worst score) to 100% (best score). Walking improvement change assessed from baseline to 12 months.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Walking improvement rates are based on number of evaluable subjects - subjects with the data point collected.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon RCT Standard Balloon Angioplasty RCT
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
    Measure Participants 247 90
    Mean (Standard Deviation) [Percentage increase]
    32.29
    (39.40)
    34.72
    (36.85)

    Adverse Events

    Time Frame Adverse event data collected through one year post-index procedure.
    Adverse Event Reporting Description LB Substudy: 6 month data displayed PK substudy: Adverse events are collected as required in RCT but not analyzed.
    Arm/Group Title RANGER™ Paclitaxel Coated Balloon Standard Balloon Angioplasty Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Arm/Group Description RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
    All Cause Mortality
    RANGER™ Paclitaxel Coated Balloon Standard Balloon Angioplasty Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/259 (1.9%) 2/93 (2.2%) 2/52 (3.8%) 1/12 (8.3%)
    Serious Adverse Events
    RANGER™ Paclitaxel Coated Balloon Standard Balloon Angioplasty Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 127/278 (45.7%) 47/98 (48%) 22/52 (42.3%) 0/0 (NaN)
    Blood and lymphatic system disorders
    Anaemia 2/278 (0.7%) 2 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Iron deficiency anaemia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Cardiac disorders
    Acute myocardial infarction 2/278 (0.7%) 2 1/98 (1%) 1 1/52 (1.9%) 1 1/0 (Infinity) 1
    Angina pectoris 4/278 (1.4%) 4 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Angina unstable 3/278 (1.1%) 3 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Aortic valve incompetence 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Atrial fibrillation 3/278 (1.1%) 4 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Atrioventricular block 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Cardiac arrest 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Cardiac failure 1/278 (0.4%) 1 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Cardiac failure acute 1/278 (0.4%) 1 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Cardiac failure congestive 3/278 (1.1%) 4 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Coronary artery disease 3/278 (1.1%) 3 3/98 (3.1%) 5 1/52 (1.9%) 2 1/0 (Infinity) 2
    Coronary artery occlusion 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Coronary artery stenosis 3/278 (1.1%) 3 1/98 (1%) 1 2/52 (3.8%) 3 2/0 (Infinity) 3
    Ischaemic cardiomyopathy 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Mitral valve incompetence 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Myocardial infarction 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Ventricular tachycardia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Ear and labyrinth disorders
    Vertigo 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Eye disorders
    Cataract 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Eyelid cyst 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Gastrointestinal disorders
    Abdominal pain 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Abdominal pain upper 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Constipation 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Diarrhoea 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Enteritis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Gastrointestinal haemorrhage 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Inguinal hemia 0/278 (0%) 0 3/98 (3.1%) 3 1/52 (1.9%) 1 1/0 (Infinity) 1
    Large intestinal stenosis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Lower gastrointestinal haemorrhage 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Melaena 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Pancreatitis acute 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Retroperitoneal haematoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Upper gastrointestinal haemorrhage 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    General disorders
    Accidental death 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Catheter site haematoma 4/278 (1.4%) 5 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Chest pain 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Death 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Device related thrombosis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    General physical health deterioration 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Implant site inflammation 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Non-cardiac chest pain 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Oedema peripheral 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Hepatobiliary disorders
    Cholelithiasis 1/278 (0.4%) 1 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Infections and infestations
    Bronchitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Bronchopulmonary aspergillosis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Cellulitis 2/278 (0.7%) 2 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Cystitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Device related infection 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Diverticulitis 2/278 (0.7%) 2 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Enteritis infectious 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Gastroenteritis norovirus 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Osteomyelitis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Pneumonia 4/278 (1.4%) 4 2/98 (2%) 2 3/52 (5.8%) 3 3/0 (Infinity) 3
    Post procedural infection 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pyelonephritis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Sepsis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Septic shock 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Urinary tract infection 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Injury, poisoning and procedural complications
    Anaemia postoperative 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Ankle fracture 0/278 (0%) 0 1/98 (1%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Cervical vertebral fracture 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Contusion 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Extradural haematoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Humerus fracture 0/278 (0%) 0 1/98 (1%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Limb traumatic amputation 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Peripheral artery bypass graft stenosis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Subdural haematoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Vascular procedure complication 11/278 (4%) 11 4/98 (4.1%) 4 2/52 (3.8%) 2 2/0 (Infinity) 2
    Vascular pseudoaneurysm 4/278 (1.4%) 4 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Investigations
    Haemoglobin decreased 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Metabolism and nutrition disorders
    Decreased appetite 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Hyperglycaemia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Hyponatraemia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Musculoskeletal and connective tissue disorders
    Back pain 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Cervical spinal stenosis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Foot deformity 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Intervertebral disc protrusion 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Mylagia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Osteoarthritis 1/278 (0.4%) 1 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Osteoporosis 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Pain in extremity 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Plantar fascitis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Rotator cuff syndrome 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign lung neoplasm 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Bladder cancer 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Chronic lymphocytic leukaemia 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Invasive ductal breast carcinoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Lung neoplasm malignant 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Malignant neoplasm of renal pelvis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Prostate cancer 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Squamous cell carcinoma of lung 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Transitional cell carcinoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Nervous system disorders
    Cerebral infarction 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Cerebrovascular accident 1/278 (0.4%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Dementia with Lewy bodies 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Headache 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Syncope 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Psychiatric disorders
    Delirium 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Mental status changes 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Renal and urinary disorders
    Acute kidney injury 3/278 (1.1%) 3 2/98 (2%) 4 0/52 (0%) 0 0/0 (NaN) 0
    Calculus urinary 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Haematuria 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Pollakiuria 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Renal failure 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Urinary bladder polyp 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Urinary retention 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Reproductive system and breast disorders
    Prostatitis 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Uterine polyp 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 2/278 (0.7%) 3 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Chronic obstructive pulmonary disease 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Dyspnoea 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Haemothorax 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pleural effusion 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pneumothorax 0/278 (0%) 0 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Pulmonary embolism 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Respiratory failure 2/278 (0.7%) 2 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Skin and subcutaneous tissue disorders
    Diabetic foot 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Drug eruption 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Skin ulcer 2/278 (0.7%) 2 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Vascular disorders
    Angiodysplasia 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Aortic aneurysm 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Arterial haemorrhage 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Deep vein thrombosis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Essential hypertension 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Haematoma 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Hypertensive crisis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Hypotension 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Intermittent claudication 17/278 (6.1%) 19 5/98 (5.1%) 6 0/52 (0%) 0 0/0 (NaN) 0
    Lower limb artery perforation 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Orthostatic hypotension 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Peripheral arterial occlusive disease 6/278 (2.2%) 9 1/98 (1%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Peripheral artery occlusion 8/278 (2.9%) 11 4/98 (4.1%) 4 1/52 (1.9%) 1 1/0 (Infinity) 1
    Peripheral artery stenosis 29/278 (10.4%) 36 14/98 (14.3%) 19 6/52 (11.5%) 7 6/0 (Infinity) 7
    Peripheral coldness 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Peripheral embolism 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Peripheral ischaemia 3/278 (1.1%) 3 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Peripheral vascular disorder 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Thrombophlebitis superficial 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Other (Not Including Serious) Adverse Events
    RANGER™ Paclitaxel Coated Balloon Standard Balloon Angioplasty Long Balloon (LB) Substudy Pharmacokinetics (PK) Substudy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 168/278 (60.4%) 60/98 (61.2%) 23/52 (44.2%) 0/0 (NaN)
    Blood and lymphatic system disorders
    Anaemia 3/278 (1.1%) 3 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Anaemia macrocytic 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Increased tendency to bruise 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Iron deficiency anaemia 2/278 (0.7%) 2 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Cardiac disorders
    Angina pectoris 5/278 (1.8%) 5 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Aortic valve stenosis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Atrial fibrillation 3/278 (1.1%) 3 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Atrial flutter 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Atrioventricular block complete 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Atrioventricular block second degree 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Bradycardia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Cardiac failure 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Palpitations 2/278 (0.7%) 2 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Ventricular extrasystoles 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Congenital, familial and genetic disorders
    Thyroglossal cyst 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Ear and labyrinth disorders
    Cerumen impaction 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Ear pain 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Tinnitus 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Vertigo 2/278 (0.7%) 2 1/98 (1%) 1 1/52 (1.9%) 1 1/0 (Infinity) 1
    Eye disorders
    Blepharitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Cataract 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Diabetic retinopathy 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Endocrine ophthalmopathy 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Heterophoria 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Mydriasis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pterygium 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Retinal tear 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Ulcerative keratitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Vitreous degeneration 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Gastrointestinal disorders
    Abdominal pain upper 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Constipation 2/278 (0.7%) 2 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Dental caries 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Diarrhoea 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Dyspepsia 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Dysphagia 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Enteritis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Gastric polyps 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Gastritis 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Gastrooesophageal reflux disease 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Gingival bleeding 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Haematochezia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Haemorrhoids 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Impaired gastric emptying 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Large intestine polyp 2/278 (0.7%) 2 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Lower gastrointestinal haemorrhage 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Melanosis coli 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Mouth ulceration 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Mucous stools 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Nausea 0/278 (0%) 0 2/98 (2%) 3 0/52 (0%) 0 0/0 (NaN) 0
    Pancreatitis 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Vomiting 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    General disorders
    Catheter site bruise 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Catheter site haematoma 1/278 (0.4%) 1 1/98 (1%) 1 1/52 (1.9%) 1 1/0 (Infinity) 1
    Catheter site pain 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Chest discomfort 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Chest pain 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Fatigue 2/278 (0.7%) 2 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Malaise 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Non-cardiac chest pain 5/278 (1.8%) 5 2/98 (2%) 3 0/52 (0%) 0 0/0 (NaN) 0
    Oedema 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Oedema peripheral 7/278 (2.5%) 7 3/98 (3.1%) 3 0/52 (0%) 0 0/0 (NaN) 0
    Pain 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Peripheral swelling 4/278 (1.4%) 5 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Pyrexia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Swelling 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Tenderness 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Immune system disorders
    Contrast media allergy 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Drug hypersensitivity 0/278 (0%) 0 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Infections and infestations
    Acute sinusitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Bronchitis 0/278 (0%) 0 4/98 (4.1%) 4 0/52 (0%) 0 0/0 (NaN) 0
    Cellulitis 4/278 (1.4%) 5 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Conjunctivitis 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Cystitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Genital infection fungal 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Herpes zoster 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Herpes zoster oticus 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Infection 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Nasopharyngitis 3/278 (1.1%) 3 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Osteomyelitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Otitis media acute 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Periodontitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pneumonia 6/278 (2.2%) 6 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pneumonia bacterial 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Pyelonephritis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Sinusitis 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Tracheobronchitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Upper respiratory tract infection 4/278 (1.4%) 4 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Urinary tract infection 3/278 (1.1%) 3 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Viral infection 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Vulval abscess 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Wound infection 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Injury, poisoning and procedural complications
    Arthropod bite 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Contusion 6/278 (2.2%) 6 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Eschar 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Face injury 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Facial bones fracture 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Fall 1/278 (0.4%) 1 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Fibula fracture 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Head injury 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Joint dislocation 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Joint injury 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Laceration 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Multiple injuries 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Procedural pain 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Rib fracture 1/278 (0.4%) 1 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Road traffic accident 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Spinal fracture 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Subcutaneous haematoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Vascular access site haematoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Vascular procedure complication 11/278 (4%) 11 2/98 (2%) 2 1/52 (1.9%) 1 1/0 (Infinity) 1
    Vascular pseudoaneurysm 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Wound 1/278 (0.4%) 1 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Investigations
    Ankle brachial index decreased 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Blood pressure increased 3/278 (1.1%) 3 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Blood urine present 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Carotid bruit 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Lipids abnormal 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pulse absent 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Right ventricular systolic pressure 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Ultrasound Doppler abnormal 0/278 (0%) 0 1/98 (1%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Weight decreased 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Metabolism and nutrition disorders
    Dehydration 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Diabetes mellitus 5/278 (1.8%) 5 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Gout 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Hyperglycaemia 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Hypoglycaemia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Type 2 diabetes mellitus 3/278 (1.1%) 3 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 11/278 (4%) 11 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Arthritis 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Back pain 9/278 (3.2%) 9 4/98 (4.1%) 4 1/52 (1.9%) 1 1/0 (Infinity) 1
    Foot deformity 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 2 1/0 (Infinity) 2
    Joint swelling 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Limb discomfort 2/278 (0.7%) 2 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Muscle spasms 2/278 (0.7%) 2 1/98 (1%) 1 1/52 (1.9%) 1 1/0 (Infinity) 1
    Muscle tightness 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Muscular weakness 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Musculoskeletal discomfort 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Musculoskeletal pain 5/278 (1.8%) 5 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Musculoskeletal stiffness 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Osteoarthritis 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pain in extremity 15/278 (5.4%) 16 6/98 (6.1%) 6 2/52 (3.8%) 2 2/0 (Infinity) 2
    Plantar fascitis 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Rotator cuff syndrome 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Spinal column stenosis 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Spinal osteoarthritis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Tendon pain 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Tendonitis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Tenosynovitis stenosans 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Wrist deformity 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal adenoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Basal cell carcinoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Benign lung neoplasm 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Benign neoplasm of adrenal gland 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Hepatocellular carinoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Lipoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Neoplasm malignant 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Neuroma 0/278 (0%) 0 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Skin papilloma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Small cell lung cancer 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Squamous cell carcinoma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Squamous cell carcinoma of skin 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Thyroid cancer 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Nervous system disorders
    Amnesia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Ataxia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Balance disorder 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Carotid artery aneurysm 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Carotid artery disease 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Carotid artery stenosis 0/278 (0%) 0 1/98 (1%) 1 1/52 (1.9%) 1 1/0 (Infinity) 1
    Dizziness 2/278 (0.7%) 2 5/98 (5.1%) 6 0/52 (0%) 0 0/0 (NaN) 0
    Headache 2/278 (0.7%) 2 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Hypoaesthesia 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Lumbar radiculopathy 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Migraine 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Neuralgia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Neuropathy peripheral 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Paraesthesia 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Parkinson's disease 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Postural tremor 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Presyncope 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Restless legs syndrome 2/278 (0.7%) 2 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Sciatica 4/278 (1.4%) 4 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Seizure 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Subarachnoid haemorrhage 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Syncope 1/278 (0.4%) 1 2/98 (2%) 3 0/52 (0%) 0 0/0 (NaN) 0
    Transient ischaemic attack 0/278 (0%) 0 1/98 (1%) 1 1/52 (1.9%) 1 1/0 (Infinity) 1
    Trigeminal neuralgia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Psychiatric disorders
    Anxiety 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Insomnia 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Middle insomnia 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Renal and urinary disorders
    Acute kidney injury 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Dysuria 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Haematuria 0/278 (0%) 0 1/98 (1%) 1 1/52 (1.9%) 1 1/0 (Infinity) 1
    Nephritis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Neurogenic bladder 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Nocturia 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pollakiuria 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Renal disorder 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Renal failure 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Urinary hesitation 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/278 (0.4%) 1 3/98 (3.1%) 3 0/52 (0%) 0 0/0 (NaN) 0
    Erectile dysfunction 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Female genital tract fistula 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Prostatitis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Chronic obstructive pulmonary disease 4/278 (1.4%) 4 2/98 (2%) 2 0/52 (0%) 0 0/0 (NaN) 0
    Cough 3/278 (1.1%) 3 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Dyspnoea 3/278 (1.1%) 3 3/98 (3.1%) 5 1/52 (1.9%) 1 1/0 (Infinity) 1
    Dyspnoea exertional 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Emphysema 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Epiglottic mass 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Epistaxis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pleural effusion 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pleurisy 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Respiratory failure 1/278 (0.4%) 1 0/98 (0%) 0 1/52 (1.9%) 1 1/0 (Infinity) 1
    Respiratory tract congestion 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Rhinorrhoea 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Sleep apnoea syndrome 2/278 (0.7%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Upper respiratory tract inflammation 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Skin and subcutaneous tissue disorders
    Chronic pigmented purpura 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Dermatitis allergic 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Dermatitis contact 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Drug eruption 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Eczema 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Haemorrhage subcutaneous 3/278 (1.1%) 3 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Hyperkeratosis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Ingrowing nail 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Pruritus 1/278 (0.4%) 1 2/98 (2%) 2 1/52 (1.9%) 1 1/0 (Infinity) 1
    Rash 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Skin exfoliation 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Skin lesion 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Skin ulcer 1/278 (0.4%) 1 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Stasis dermatitis 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Vascular disorders
    Blue toe syndrome 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Embolism arterial 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Haematoma 4/278 (1.4%) 4 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Haemorrhage 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Hypertension 8/278 (2.9%) 9 3/98 (3.1%) 3 0/52 (0%) 0 0/0 (NaN) 0
    Hypotension 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Intermittent claudication 28/278 (10.1%) 34 9/98 (9.2%) 11 2/52 (3.8%) 2 2/0 (Infinity) 2
    Internal haemorrhage 0/278 (0%) 0 1/98 (1%) 1 0/52 (0%) 0 0/0 (NaN) 0
    Orthostatic hypotension 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Peripheral arterial occlusive disease 2/278 (0.7%) 2 0/98 (0%) 0 1/52 (1.9%) 2 1/0 (Infinity) 2
    Peripheral artery occlusion 1/278 (0.4%) 1 1/98 (1%) 1 1/52 (1.9%) 1 1/0 (Infinity) 1
    Peripheral artery stenosis 9/278 (3.2%) 11 6/98 (6.1%) 6 6/52 (11.5%) 6 6/0 (Infinity) 6
    Peripheral venous disease 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Subclavian steal syndrome 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Thrombosis 1/278 (0.4%) 1 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0
    Varicose vein 1/278 (0.4%) 2 0/98 (0%) 0 0/52 (0%) 0 0/0 (NaN) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Philip Ghizoni
    Organization Boston Scientific
    Phone 763-255-0036
    Email Philip.Ghizoni@bsci.com
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT03064126
    Other Study ID Numbers:
    • S2062
    First Posted:
    Feb 24, 2017
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022