RANGER II SFA: RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
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 |
---|---|---|
|
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
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:
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:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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
- 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.
- 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.
- 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.
- 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).
- 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.
- 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
- 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
- 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.
- 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.
- 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
Inclusion Criteria:
-
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;
-
Subject at least 20 years of age;
-
Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4;
-
Target lesion is in the native SFA and/or PPA down to the P1 segment;
-
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;
-
Reference vessel diameter ≥ 4 mm and ≤ 8 mm by visual estimate;
-
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:
-
Life expectancy, documented in the Investigator's opinion, of less than 12 months;
-
Hemorrhagic stroke or cardiac event (e.g. STEMI, unstable angina) within 6 months prior to enrollment;
-
Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
-
Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated;
-
Chronic renal insufficiency with serum creatinine > 2.0 mg/dL within 30 days of index procedure or treatment with dialysis;
-
Platelet count < 80,000 mm 3 or > 600,000 mm 3 or history of bleeding diathesis;
-
Receiving immunosuppressive therapy;
-
Septicemia at the time of enrollment;
-
Any major intervention planned within 30 days post index procedure;
-
Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of enrollment;
-
Failure to successfully cross the target lesion with a guidewire;
-
Failure to successfully pre-dilate the target vessel;
-
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;
-
History of major amputation in the target limb;
-
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;
-
Pregnant or breast feeding;
-
Presence of aneurysm in the target vessel;
-
Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment;
-
Patient has significant inflow disease which cannot be treated prior to the target lesion treatment;
-
Patient has perforated targeted vessel as evidenced by extravasation of contrast media;
-
Patient has severe calcification that renders the lesion undilatable;
-
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
- Kakkar AM, Abbott JD. Percutaneous versus surgical management of lower extremity peripheral artery disease. Curr Atheroscler Rep. 2015;17(2):479. doi: 10.1007/s11883-014-0479-0. Review.
- Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
- Litsky J, Chanda A, Stilp E, Lansky A, Mena C. Critical evaluation of stents in the peripheral arterial disease of the superficial femoral artery - focus on the paclitaxel eluting stent. Med Devices (Auckl). 2014 May 28;7:149-56. doi: 10.2147/MDER.S45472. eCollection 2014. Review.
- Razavi MK, Mustapha JA, Miller LE. Contemporary systematic review and meta-analysis of early outcomes with percutaneous treatment for infrapopliteal atherosclerotic disease. J Vasc Interv Radiol. 2014 Oct;25(10):1489-96, 1496.e1-3. doi: 10.1016/j.jvir.2014.06.018. Epub 2014 Aug 15. Review.
- Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022.
- S2062
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
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 |
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 |
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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%
|
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)
|
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
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 |
Philip.Ghizoni@bsci.com |
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