EU RCT: ILLUMENATE EU Randomized Clinical Trial
Sponsor
Spectranetics Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01858363
Collaborator
(none)
294
1
2
95
3.1
Study Details
Study Description
Brief Summary
This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
294 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Prospective, Randomized, Multi-center, Single-blinded Study for the Treatment of Subjects Presenting With De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using Paclitaxel or Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Study Start Date
:
Nov 1, 2012
Actual Primary Completion Date
:
Mar 1, 2016
Actual Study Completion Date
:
Oct 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Paclitaxel-coated balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. |
Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
|
| Placebo Comparator: Bare balloon Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. |
Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter
|
Outcome Measures
Primary Outcome Measures
- Patency at 12-months [12 months]
The primary efficacy endpoint was patency at 12 months post-procedure defined as the absence of target lesion restenosis determined by duplex ultrasound peak systolic velocity ratio (PSVR) ≤2.5 and freedom from clinically-driven target lesion revascularization (CD-TLR).
- Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month [30-Days and 12-Months]
The primary safety endpoint was freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 12 months post-procedure.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries
-
Rutherford clinical category 2, 3 or 4
-
Male or non-pregnant female at least 18 years
Exclusion Criteria:
-
Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries
-
Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
-
Known intolerance of study medications, paclitaxel or contrast agent
-
Active participation in another investigational device or drug study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Diagnostic Radiology and Minimally Invasive Therapy | Berlin | Germany |
Sponsors and Collaborators
- Spectranetics Corporation
Investigators
- Principal Investigator: Henrik Schroeder, M.D., Center for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT01858363
Other Study ID Numbers:
- TP 1360
First Posted:
May 21, 2013
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Spectranetics Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Paclitaxel-coated Balloon | Bare Balloon |
|---|---|---|
| Arm/Group Description | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter |
| Period Title: Overall Study | ||
| STARTED | 222 | 72 |
| Pre-discharge Visit | 219 | 72 |
| 1-month Visit | 214 | 68 |
| 6-month Visit | 208 | 64 |
| 12-month Vist | 205 | 61 |
| 24-month Visit | 184 | 58 |
| 36-month Visit | 169 | 53 |
| 48-month Visit | 157 | 53 |
| COMPLETED | 146 | 46 |
| NOT COMPLETED | 76 | 26 |
Baseline Characteristics
| Arm/Group Title | Paclitaxel-coated Balloon | Bare Balloon | Total |
|---|---|---|---|
| Arm/Group Description | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter | Total of all reporting groups |
| Overall Participants | 222 | 72 | 294 |
| Overall lesions | 254 | 79 | 333 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
66.8
(9.2)
|
69.0
(8.6)
|
67.3
(9.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
62
27.9%
|
23
31.9%
|
85
28.9%
|
| Male |
160
72.1%
|
49
68.1%
|
209
71.1%
|
| Rutherford Clinical Category (Count of Participants) | |||
| Rutherford Clinical Category 2 |
34
15.3%
|
15
20.8%
|
49
16.7%
|
| Rutherford Clinical Category 3 |
183
82.4%
|
55
76.4%
|
238
81%
|
| Rutherford Clinical Category 4 |
4
1.8%
|
1
1.4%
|
5
1.7%
|
| Diabetes (Count of Participants) | |||
| Count of Participants [Participants] |
83
37.4%
|
26
36.1%
|
109
37.1%
|
| Hypertension (Count of Participants) | |||
| Count of Participants [Participants] |
173
77.9%
|
60
83.3%
|
233
79.3%
|
| Hyperlipidemia (Count of Participants) | |||
| Count of Participants [Participants] |
137
61.7%
|
49
68.1%
|
186
63.3%
|
| Smoking status (Count of Participants) | |||
| Never Smoked |
24
10.8%
|
12
16.7%
|
36
12.2%
|
| Previous or current |
198
89.2%
|
60
83.3%
|
258
87.8%
|
| Baseline Ankle Brachial Index (ratio) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [ratio] |
0.72
(0.21)
|
0.69
(0.26)
|
0.71
(0.22)
|
| Lesion length (mm) (mm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mm] |
71.8
(51.9)
|
70.8
(52.7)
|
71.6
(52.0)
|
| Lesion type (lesions) [Count of Units] | |||
| De novo |
234
|
71
|
305
|
| Restonotic |
20
|
8
|
28
|
| Total Occlusion (lesions) [Count of Units] | |||
| Count of Units [lesions] |
48
|
15
|
63
|
| Calcification (lesions) [Count of Units] | |||
| None/Mild |
140
|
47
|
187
|
| Moderate |
79
|
24
|
103
|
| Severe |
32
|
8
|
40
|
| Diameter stenosis (% Diameter Stenosis) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [% Diameter Stenosis] |
78.7
(16.0)
|
80.8
(15.7)
|
79.2
(15.9)
|
| Reference vessel Diameter (mm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mm] |
5.02
(0.79)
|
4.77
(0.69)
|
4.96
(0.78)
|
| # of patent run-off vessels (Count of Participants) | |||
| 0 |
18
8.1%
|
4
5.6%
|
22
7.5%
|
| 1 |
40
18%
|
9
12.5%
|
49
16.7%
|
| 2 |
68
30.6%
|
31
43.1%
|
99
33.7%
|
| 3 |
85
38.3%
|
24
33.3%
|
109
37.1%
|
| pre-dilatation performed (lesions) [Count of Units] | |||
| Count of Units [lesions] |
254
|
78
|
332
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
27.2
(4.7)
|
27.8
(4.7)
|
27.3
(4.7)
|
Outcome Measures
| Title | Patency at 12-months |
|---|---|
| Description | The primary efficacy endpoint was patency at 12 months post-procedure defined as the absence of target lesion restenosis determined by duplex ultrasound peak systolic velocity ratio (PSVR) ≤2.5 and freedom from clinically-driven target lesion revascularization (CD-TLR). |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis for the primary patency was based on the lesion success and not participant success. In the Paclitaxel-coated balloon arm, 222 subjects represents 254 lesions. Of those 254 lesions, only 224 lesions were evaluable. In the Bare balloon arm, 72 subjects represents 79 lesions. Of those 79 lesions, only 66 lesions were evaluable. |
| Arm/Group Title | Paclitaxel-coated Balloon | Bare Balloon |
|---|---|---|
| Arm/Group Description | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter |
| Measure Participants | 222 | 72 |
| Measure lesions | 224 | 66 |
| Number (95% Confidence Interval) [percentage of lesions] |
83.9
|
60.6
|
| Title | Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month |
|---|---|
| Description | The primary safety endpoint was freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 12 months post-procedure. |
| Time Frame | 30-Days and 12-Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Paclitaxel-coated Balloon | Bare Balloon |
|---|---|---|
| Arm/Group Description | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter |
| Measure Participants | 222 | 72 |
| Number (95% Confidence Interval) [percentage of participants] |
94.1
42.4%
|
83.3
115.7%
|
Adverse Events
| Time Frame | The adverse events presented were collected through 12 Months. The data presented is based off the Safety Set (analysis set). The Safety Set excludes 7 participants who were not treated with a study device. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Paclitaxel-coated Balloon | Bare Balloon | ||
| Arm/Group Description | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon. Bare Percutaneous Transluminal Angioplasty Balloon Catheter | ||
All Cause Mortality |
||||
| Paclitaxel-coated Balloon | Bare Balloon | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/219 (16%) | 9/68 (13.2%) | ||
Serious Adverse Events |
||||
| Paclitaxel-coated Balloon | Bare Balloon | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 118/219 (53.9%) | 38/68 (55.9%) | ||
| Blood and lymphatic system disorders | ||||
| ANAEMIA | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| IRON DEFICIENCY ANAEMIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Cardiac disorders | ||||
| ACUTE MYOCARDIAL INFARCTION | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| ANGINA PECTORIS | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| ANGINA UNSTABLE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| ARTERIOSCLEROSIS CORONARY ARTERY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| ATRIAL FIBRILLATION | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| ATRIAL FLUTTER | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| BRADYCARDIA | 1/219 (0.5%) | 3 | 0/68 (0%) | 0 |
| CARDIAC ARREST | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CARDIAC FAILURE | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| CORONARY ARTERY DISEASE | 9/219 (4.1%) | 11 | 0/68 (0%) | 0 |
| CORONARY ARTERY STENOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| MYOCARDIAL INFARCTION | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| SUPRAVENTRICULAR TACHYCARDIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| ENDOCARDIAL FIBROELASTOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Eye disorders | ||||
| CATARACT | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| EYELID PTOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| LENS DISLOCATION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| MACULAR DEGENERATION | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| RETINAL ARTERY OCCLUSION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RETINAL DETACHMENT | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| Gastrointestinal disorders | ||||
| ABDOMINAL PAIN | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| COLITIS | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| COLITIS ULCERATIVE | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| CONSTIPATION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CROHN'S DISEASE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DYSPEPSIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GASTROINTESTINAL HAEMORRHAGE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| HAEMATOCHEZIA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| HAEMORRHOIDS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| INGUINAL HERNIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| INTESTINAL ISCHAEMIA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| LARGE INTESTINAL ULCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| LARGE INTESTINE POLYP | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| NAUSEA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| PANCREATITIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| PANCREATITIS CHRONIC | 0/219 (0%) | 0 | 2/68 (2.9%) | 5 |
| PROCTITIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| UPPER GASTROINTESTINAL HAEMORRHAGE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| General disorders | ||||
| CATHETER SITE HAEMATOMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CATHETER SITE HAEMORRHAGE | 5/219 (2.3%) | 5 | 0/68 (0%) | 0 |
| CHEST PAIN | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DEVICE OCCLUSION | 4/219 (1.8%) | 4 | 0/68 (0%) | 0 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| IMPAIRED HEALING | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| NECROSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PAIN | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| THROMBOSIS IN DEVICE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Hepatobiliary disorders | ||||
| CHOLECYSTITIS ACUTE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CHOLESTASIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 2 |
| HEPATIC CIRRHOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| HEPATIC FAILURE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Infections and infestations | ||||
| ESCHERICHIA INFECTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GASTROENTERITIS VIRAL | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GASTROINTESTINAL INFECTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PERITONITIS | 1/219 (0.5%) | 3 | 0/68 (0%) | 0 |
| PNEUMONIA | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| PNEUMONIA KLEBSIELLA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RESPIRATORY TRACT INFECTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TUBERCULOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TUBERCULOSIS OF GENITOURINARY SYSTEM | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| URINARY TRACT INFECTION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| Injury, poisoning and procedural complications | ||||
| CONFUSION POSTOPERATIVE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| FEMORAL NECK FRACTURE | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| FEMUR FRACTURE | 0/219 (0%) | 0 | 2/68 (2.9%) | 2 |
| HUMERUS FRACTURE | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| INCISIONAL HERNIA | 0/219 (0%) | 0 | 1/68 (1.5%) | 2 |
| LACERATION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| LUMBAR VERTEBRAL FRACTURE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| MULTIPLE FRACTURES | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PERIPHERAL ARTERIAL REOCCLUSION | 2/219 (0.9%) | 2 | 1/68 (1.5%) | 1 |
| PERIPHERAL ARTERY RESTENOSIS | 6/219 (2.7%) | 6 | 12/68 (17.6%) | 13 |
| RADIUS FRACTURE | 0/219 (0%) | 0 | 2/68 (2.9%) | 2 |
| TENDON INJURY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| VASCULAR PSEUDOANEURYSM | 3/219 (1.4%) | 3 | 2/68 (2.9%) | 2 |
| Investigations | ||||
| BLOOD GLUCOSE FLUCTUATION | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| DEHYDRATION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| HYPERGLYCAEMIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| HYPOGLYCAEMIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TYPE 2 DIABETES MELLITUS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| BACK PAIN | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| FACET JOINT SYNDROME | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| INTERVERTEBRAL DISC PROTRUSION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| JOINT SWELLING | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| MUSCULOSKELETAL PAIN | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| OSTEOARTHRITIS | 5/219 (2.3%) | 5 | 0/68 (0%) | 0 |
| PAIN IN EXTREMITY | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| ROTATOR CUFF SYNDROME | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SPINAL OSTEOARTHRITIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SPONDYLOLISTHESIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| ADENOCARCINOMA OF COLON | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BENIGN NEOPLASM | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BRAIN NEOPLASM | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BREAST CANCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BRONCHIAL CARCINOMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| COLON CANCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GASTRIC CANCER | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| GASTROINTESTINAL TRACT ADENOMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| METASTASIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PANCREATIC CARCINOMA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| POLYCYTHAEMIA VERA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PROSTATE CANCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SQUAMOUS CELL CARCINOMA | 0/219 (0%) | 0 | 1/68 (1.5%) | 2 |
| SQUAMOUS CELL CARCINOMA OF SKIN | 0/219 (0%) | 0 | 1/68 (1.5%) | 2 |
| Nervous system disorders | ||||
| ATAXIA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| CAROTID ARTERY STENOSIS | 6/219 (2.7%) | 7 | 0/68 (0%) | 0 |
| CEREBRAL HAEMORRHAGE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CEREBROVASCULAR ACCIDENT | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| ISCHAEMIC CEREBRAL INFARCTION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| MIGRAINE WITH AURA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Psychiatric disorders | ||||
| DEPRESSION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| Renal and urinary disorders | ||||
| BLADDER MASS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RENAL ARTERY STENOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RENAL FAILURE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| URINARY RETENTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 3/219 (1.4%) | 3 | 1/68 (1.5%) | 1 |
| EPISTAXIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PLEURAL EFFUSION | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| PNEUMOTHORAX | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| PULMONARY EMBOLISM | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RESPIRATORY FAILURE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SLEEP APNOEA SYNDROME | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| SKIN ULCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Surgical and medical procedures | ||||
| CAROTID ENDARTERECTOMY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CARPAL TUNNEL DECOMPRESSION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CHOLECYSTECTOMY | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| CORONARY ARTERY BYPASS | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| GASTROINTESTINAL DILATION PROCEDURE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| KNEE ARTHROPLASTY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PERIPHERAL ENDARTERECTOMY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Vascular disorders | ||||
| BLUE TOE SYNDROME | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CIRCULATORY COLLAPSE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DEEP VEIN THROMBOSIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| FEMORAL ARTERY DISSECTION | 17/219 (7.8%) | 18 | 6/68 (8.8%) | 6 |
| FEMORAL ARTERY OCCLUSION | 5/219 (2.3%) | 6 | 1/68 (1.5%) | 1 |
| HYPERTENSIVE CRISIS | 4/219 (1.8%) | 4 | 0/68 (0%) | 0 |
| INTERMITTENT CLAUDICATION | 3/219 (1.4%) | 3 | 1/68 (1.5%) | 1 |
| PELVIC VENOUS THROMBOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| PERIPHERAL ARTERY DISSECTION | 3/219 (1.4%) | 3 | 1/68 (1.5%) | 1 |
| PERIPHERAL ARTERY STENOSIS | 15/219 (6.8%) | 20 | 6/68 (8.8%) | 9 |
| PERIPHERAL ARTERY THROMBOSIS | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| PERIPHERAL EMBOLISM | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| PERIPHERAL ISCHAEMIA | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| THROMBOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| VENOUS THROMBOSIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Paclitaxel-coated Balloon | Bare Balloon | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 180/219 (82.2%) | 51/68 (75%) | ||
| Blood and lymphatic system disorders | ||||
| ANAEMIA | 4/219 (1.8%) | 4 | 0/68 (0%) | 0 |
| EOSINOPHILIA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| IRON DEFICIENCY ANAEMIA | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| Cardiac disorders | ||||
| ACUTE MYOCARDIAL INFARCTION | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| ANGINA PECTORIS | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| ANGINA UNSTABLE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| ARRHYTHMIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| ARTERIOSCLEROSIS CORONARY ARTERY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| ATRIAL FIBRILLATION | 4/219 (1.8%) | 4 | 0/68 (0%) | 0 |
| ATRIAL FLUTTER | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| BRADYCARDIA | 1/219 (0.5%) | 3 | 0/68 (0%) | 0 |
| CARDIAC ARREST | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CARDIAC FAILURE | 3/219 (1.4%) | 4 | 0/68 (0%) | 0 |
| CORONARY ARTERY DISEASE | 10/219 (4.6%) | 14 | 0/68 (0%) | 0 |
| CORONARY ARTERY STENOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| MYOCARDIAL INFARCTION | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| SUPRAVENTRICULAR TACHYCARDIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TACHYCARDIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| ENDOCARDIAL FIBROELASTOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| CERUMEN IMPACTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| VERTIGO | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| Endocrine disorders | ||||
| HYPERTHYROIDISM | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| Eye disorders | ||||
| CATARACT | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 2 |
| CHORIORETINOPATHY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DIABETIC RETINOPATHY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| EYELID PTOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| LENS DISLOCATION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| MACULAR DEGENERATION | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| RETINAL ARTERY OCCLUSION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RETINAL DETACHMENT | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| VITREOUS HAEMORRHAGE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Gastrointestinal disorders | ||||
| ABDOMINAL PAIN | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| ABDOMINAL PAIN LOWER | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| ABDOMINAL PAIN UPPER | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| COLITIS | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| COLITIS ULCERATIVE | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| CONSTIPATION | 5/219 (2.3%) | 6 | 0/68 (0%) | 0 |
| CROHN'S DISEASE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DYSPEPSIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GASTRITIS | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| GASTROINTESTINAL HAEMORRHAGE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| HAEMATOCHEZIA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| HAEMORRHOIDS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| INGUINAL HERNIA | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| INTESTINAL ISCHAEMIA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| INTESTINAL POLYP | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| LARGE INTESTINAL ULCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| LARGE INTESTINE POLYP | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| NAUSEA | 0/219 (0%) | 0 | 2/68 (2.9%) | 2 |
| OESOPHAGITIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| PANCREATITIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| PANCREATITIS CHRONIC | 0/219 (0%) | 0 | 2/68 (2.9%) | 5 |
| PROCTITIS | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| SALIVARY GLAND CYST | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TOOTH DISORDER | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| UPPER GASTROINTESTINAL HAEMORRHAGE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| General disorders | ||||
| CATHETER SITE HAEMATOMA | 4/219 (1.8%) | 4 | 2/68 (2.9%) | 2 |
| CATHETER SITE HAEMORRHAGE | 7/219 (3.2%) | 7 | 0/68 (0%) | 0 |
| CHEST DISCOMFORT | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CHEST PAIN | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DEVICE BREAKAGE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DEVICE OCCLUSION | 4/219 (1.8%) | 5 | 0/68 (0%) | 0 |
| FATIGUE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| IMPAIRED HEALING | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| LOCAL SWELLING | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| LOCALISED OEDEMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| NECROSIS | 1/219 (0.5%) | 2 | 1/68 (1.5%) | 1 |
| OEDEMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| OEDEMA PERIPHERAL | 5/219 (2.3%) | 5 | 1/68 (1.5%) | 1 |
| PAIN | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PUNCTURE SITE HAEMORRHAGE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| THROMBOSIS IN DEVICE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Hepatobiliary disorders | ||||
| BILIARY CIRRHOSIS PRIMARY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CHOLECYSTITIS ACUTE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CHOLELITHIASIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| CHOLESTASIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 2 |
| HEPATIC CIRRHOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| HEPATIC FAILURE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| LIVER DISORDER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Immune system disorders | ||||
| HYPERSENSITIVITY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Infections and infestations | ||||
| BRONCHITIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| EAR INFECTION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| ERYSIPELAS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| ESCHERICHIA INFECTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| FUNGAL INFECTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GASTROENTERITIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GASTROENTERITIS VIRAL | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| GASTROINTESTINAL INFECTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| HERPES ZOSTER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| INFLUENZA | 2/219 (0.9%) | 2 | 1/68 (1.5%) | 1 |
| NASOPHARYNGITIS | 8/219 (3.7%) | 8 | 0/68 (0%) | 0 |
| OSTEOMYELITIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PERITONITIS | 1/219 (0.5%) | 3 | 0/68 (0%) | 0 |
| PNEUMONIA | 3/219 (1.4%) | 3 | 1/68 (1.5%) | 1 |
| PNEUMONIA KLEBSIELLA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RESPIRATORY TRACT INFECTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SINUSITIS | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| TONSILLITIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TUBERCULOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TUBERCULOSIS OF GENITOURINARY SYSTEM | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| UPPER RESPIRATORY TRACT INFECTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| URINARY TRACT INFECTION | 2/219 (0.9%) | 2 | 1/68 (1.5%) | 1 |
| Injury, poisoning and procedural complications | ||||
| ACCIDENTAL OVERDOSE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| ANIMAL BITE | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| ARTERIAL RESTENOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BRAIN CONTUSION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CONCUSSION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CONFUSION POSTOPERATIVE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CONTUSION | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| FALL | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| FEMORAL NECK FRACTURE | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| FEMUR FRACTURE | 0/219 (0%) | 0 | 2/68 (2.9%) | 2 |
| HAND FRACTURE | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| HUMERUS FRACTURE | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| INCISIONAL HERNIA | 0/219 (0%) | 0 | 1/68 (1.5%) | 2 |
| INJURY | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| JOINT DISLOCATION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| LACERATION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| LUMBAR VERTEBRAL FRACTURE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| MULTIPLE FRACTURES | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| NECK INJURY | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| PERIPHERAL ARTERIAL REOCCLUSION | 4/219 (1.8%) | 4 | 3/68 (4.4%) | 4 |
| PERIPHERAL ARTERY RESTENOSIS | 20/219 (9.1%) | 20 | 15/68 (22.1%) | 21 |
| POST PROCEDURAL HAEMATOMA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| RADIUS FRACTURE | 0/219 (0%) | 0 | 2/68 (2.9%) | 3 |
| SEROMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SPINAL COLUMN INJURY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TENDON INJURY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TRAUMATIC ULCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| VASCULAR PSEUDOANEURYSM | 4/219 (1.8%) | 4 | 3/68 (4.4%) | 3 |
| WOUND | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Investigations | ||||
| ANKLE BRACHIAL INDEX DECREASED | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| BLOOD CHOLESTEROL INCREASED | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BLOOD COUNT ABNORMAL | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BLOOD GLUCOSE FLUCTUATION | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| BLOOD PRESSURE INCREASED | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| INTRAOCULAR PRESSURE INCREASED | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| WEIGHT DECREASED | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| DEHYDRATION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| GOUT | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| HYPERGLYCAEMIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| HYPOGLYCAEMIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TYPE 2 DIABETES MELLITUS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 14/219 (6.4%) | 14 | 5/68 (7.4%) | 7 |
| ARTHRITIS | 2/219 (0.9%) | 2 | 1/68 (1.5%) | 1 |
| BACK PAIN | 10/219 (4.6%) | 10 | 0/68 (0%) | 0 |
| BONE PAIN | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BURSITIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| EXOSTOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| FACET JOINT SYNDROME | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GROIN PAIN | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| INTERVERTEBRAL DISC DEGENERATION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| INTERVERTEBRAL DISC PROTRUSION | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| JOINT EFFUSION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| JOINT SWELLING | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| MUSCLE SPASMS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| MUSCULAR WEAKNESS | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| MUSCULOSKELETAL PAIN | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| MYALGIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| NECK PAIN | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| OSTEOARTHRITIS | 7/219 (3.2%) | 7 | 2/68 (2.9%) | 3 |
| OSTEOCHONDRITIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| OSTEOCHONDROSIS | 0/219 (0%) | 0 | 2/68 (2.9%) | 2 |
| PAIN IN EXTREMITY | 14/219 (6.4%) | 15 | 4/68 (5.9%) | 4 |
| RHEUMATOID ARTHRITIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| ROTATOR CUFF SYNDROME | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SINUS TARSI SYNDROME | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SPINAL OSTEOARTHRITIS | 4/219 (1.8%) | 4 | 0/68 (0%) | 0 |
| SPINAL PAIN | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SPONDYLOLISTHESIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TENDONITIS | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| TENOSYNOVITIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TRIGGER FINGER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| ADENOCARCINOMA OF COLON | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| ADRENAL ADENOMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BENIGN NEOPLASM | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BRAIN NEOPLASM | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BREAST CANCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BRONCHIAL CARCINOMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| COLON CANCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| GASTRIC CANCER | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| GASTROINTESTINAL TRACT ADENOMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| LIPOMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| METASTASIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PANCREATIC CARCINOMA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| POLYCYTHAEMIA VERA | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| PROSTATE CANCER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SQUAMOUS CELL CARCINOMA | 0/219 (0%) | 0 | 1/68 (1.5%) | 2 |
| SQUAMOUS CELL CARCINOMA OF SKIN | 0/219 (0%) | 0 | 1/68 (1.5%) | 2 |
| Nervous system disorders | ||||
| ATAXIA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| CAROTID ARTERY OCCLUSION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CAROTID ARTERY STENOSIS | 8/219 (3.7%) | 10 | 1/68 (1.5%) | 1 |
| CARPAL TUNNEL SYNDROME | 0/219 (0%) | 0 | 2/68 (2.9%) | 2 |
| CEREBRAL HAEMORRHAGE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CEREBROVASCULAR ACCIDENT | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| CERVICOBRACHIAL SYNDROME | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DIZZINESS | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| HEADACHE | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| HYPOAESTHESIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| ISCHAEMIC CEREBRAL INFARCTION | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| MIGRAINE WITH AURA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PARAESTHESIA | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| POLYNEUROPATHY | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| RESTLESS LEGS SYNDROME | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SENSORY LOSS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| TRIGEMINAL NEURALGIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Psychiatric disorders | ||||
| DELIRIUM | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DEPRESSION | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| Renal and urinary disorders | ||||
| BLADDER MASS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| POLLAKIURIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RENAL ARTERY STENOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RENAL FAILURE | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| URGE INCONTINENCE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| URINARY RETENTION | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| BRONCHITIS CHRONIC | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 4/219 (1.8%) | 4 | 1/68 (1.5%) | 1 |
| DYSPNOEA | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| EPISTAXIS | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| PLEURAL EFFUSION | 3/219 (1.4%) | 3 | 0/68 (0%) | 0 |
| PNEUMOTHORAX | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| PULMONARY EMBOLISM | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RESPIRATORY FAILURE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SLEEP APNOEA SYNDROME | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| BLISTER | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DRUG ERUPTION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| ECZEMA | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| PRURITUS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| RASH | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| SKIN LESION | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| SKIN ULCER | 3/219 (1.4%) | 3 | 1/68 (1.5%) | 1 |
| SUBCUTANEOUS EMPHYSEMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Surgical and medical procedures | ||||
| CAROTID ENDARTERECTOMY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CARPAL TUNNEL DECOMPRESSION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| CHOLECYSTECTOMY | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| CORONARY ARTERY BYPASS | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| GASTROINTESTINAL DILATION PROCEDURE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| KNEE ARTHROPLASTY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| MOLE EXCISION | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PERIPHERAL ENDARTERECTOMY | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| Vascular disorders | ||||
| ANGIODYSPLASIA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| BLUE TOE SYNDROME | 1/219 (0.5%) | 2 | 0/68 (0%) | 0 |
| CIRCULATORY COLLAPSE | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| DEEP VEIN THROMBOSIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
| FEMORAL ARTERY DISSECTION | 21/219 (9.6%) | 22 | 7/68 (10.3%) | 7 |
| FEMORAL ARTERY OCCLUSION | 7/219 (3.2%) | 9 | 1/68 (1.5%) | 1 |
| HAEMATOMA | 4/219 (1.8%) | 4 | 1/68 (1.5%) | 1 |
| HYPERTENSION | 3/219 (1.4%) | 3 | 1/68 (1.5%) | 1 |
| HYPERTENSIVE CRISIS | 4/219 (1.8%) | 4 | 0/68 (0%) | 0 |
| INTERMITTENT CLAUDICATION | 15/219 (6.8%) | 15 | 3/68 (4.4%) | 4 |
| LYMPHOEDEMA | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PELVIC VENOUS THROMBOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 4/219 (1.8%) | 5 | 0/68 (0%) | 0 |
| PERIPHERAL ARTERY DISSECTION | 3/219 (1.4%) | 3 | 1/68 (1.5%) | 1 |
| PERIPHERAL ARTERY STENOSIS | 21/219 (9.6%) | 29 | 9/68 (13.2%) | 21 |
| PERIPHERAL ARTERY THROMBOSIS | 2/219 (0.9%) | 3 | 0/68 (0%) | 0 |
| PERIPHERAL EMBOLISM | 2/219 (0.9%) | 2 | 0/68 (0%) | 0 |
| PERIPHERAL ISCHAEMIA | 1/219 (0.5%) | 1 | 1/68 (1.5%) | 1 |
| THROMBOSIS | 1/219 (0.5%) | 1 | 0/68 (0%) | 0 |
| VENOUS THROMBOSIS | 0/219 (0%) | 0 | 1/68 (1.5%) | 1 |
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 | Nicolas Aguirre |
|---|---|
| Organization | Spectranetics |
| Phone | +1-312-297-6655 |
| nicolas.aguirre@philips.com |
Responsible Party:
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT01858363
Other Study ID Numbers:
- TP 1360
First Posted:
May 21, 2013
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021