Full Text View
Tabular View
Study Results
Related Studies
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
This study is ongoing, but not recruiting participants.
Study NCT00180479   Information provided by Abbott Vascular
First Received: September 13, 2005   Last Updated: September 18, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Conditions: Stents
Coronary Artery Disease
Total Coronary Occlusion
Coronary Artery Restenosis
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Interventions: Device: XIENCE V® Everolimus Eluting Coronary Stent
Device: TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
1002 subjects were recruited at 65 sites. Eligible subjects invited to participate either in-hospital or in-clinic prior to first procedure and required to provide signed informed consent prior to enrollment. Final eligibility based on angiogram before the intended procedure. Dates of recruitment: 6/22/05 through 3/15/06.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized via telephone randomization and stratified by single and dual lesion/vessel treatment, diabetes mellitus status, and study sites. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.

Reporting Groups
  Description
XIENCE V® EECSS XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Participant Flow:   Overall Study
  XIENCE V® EECSS TAXUS® EXPRESS2™ ECSS
STARTED   669     333[1]
COMPLETED   653     320  
NOT COMPLETED   16     13  
      Death               4                 2  
      Lost to Follow-up               9                 7  
      Withdrawal by Subject               3                 3  
      Informed consent not signed               0                 1  
[1] 1 patient randomized never signed consent, therefore no data collected. Analysis group = 332.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
XIENCE V® EECSS XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Baseline Measures
  XIENCE V® EECSS TAXUS® EXPRESS2™ ECSS Total
Number of Participants  
[units: participants]
 		669 333 1002
Age[1]
[units: participants]
 		     
<=18 years 0 0 0
Between 18 and 65 years 376 191 567
>=65 years 293 141 434
Age[2]
[units: years]
Mean ± Standard Deviation 		63.23 ± 10.53 62.80 ± 10.24 63.08 ± 10.43
Gender[3]
[units: participants]
 		     
Female 200 114 314
Male 469 218 687
Region of Enrollment[4]
[units: participants]
 		     
United States 669 333 1002
[1] 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[2] 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[3] 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
[4] 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Primary Endpoint: In-segment Late Loss (LL)   [ 240 days ]
  Show Outcome Measure 1

2.  Secondary:   Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)   [ 270 days ]
  Show Outcome Measure 2

3.  Secondary:   Target Vessel Failure (TVF)   [ 30 days ]
  Show Outcome Measure 3

4.  Secondary:   Target Vessel Failure (TVF)   [ 180 days ]
  Show Outcome Measure 4

5.  Secondary:   Target Vessel Failure (TVF)   [ 1 year ]
  Show Outcome Measure 5

6.  Secondary:   Target Vessel Failure (TVF)   [ 2 year ]
  Show Outcome Measure 6

7.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 30 days ]
  Show Outcome Measure 7

8.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 180 days ]
  Show Outcome Measure 8

9.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 270 days ]
  Show Outcome Measure 9

10.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 1 years ]
  Show Outcome Measure 10

11.  Secondary:   Ischemia Driven Target Lesion Revascularization (ID-TLR)   [ 2 years ]
  Show Outcome Measure 11

12.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 30 days ]
  Show Outcome Measure 12

13.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 180 days ]
  Show Outcome Measure 13

14.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 270 days ]
  Show Outcome Measure 14

15.  Secondary:   Ischemia Driven Target Vessel Revascularization (ID-TVR)   [ 1 year ]
  Show Outcome Measure 15

16.  Secondary:   Ischemia Drive Target Vessel Revascularization (ID-TVR)   [ 2 years ]
  Show Outcome Measure 16

17.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 30 days ]
  Show Outcome Measure 17

18.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 180 days ]
  Show Outcome Measure 18

19.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 270 days ]
  Show Outcome Measure 19

20.  Secondary:   Ischemia Driven Major Adverse Cardiac Event (MACE)   [ 1 year ]
  Show Outcome Measure 20

21.  Secondary:   Ischemia Driven Major Adverse Cardiac Event(MACE)   [ 2 years ]
  Show Outcome Measure 21

22.  Secondary:   In-stent % Angiographic Binary Restenosis (% ABR) Rate   [ at 240 days ]
  Show Outcome Measure 22

23.  Secondary:   In-segment % Angiographic Binary Restenosis (% ABR) Rate   [ 240 days ]
  Show Outcome Measure 23

24.  Secondary:   Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection   [ at 240 days ]
  Show Outcome Measure 24

25.  Secondary:   Acute Success: Clinical Device   [ In-hospital ]
  Show Outcome Measure 25

26.  Secondary:   Acute Success: Clinical Procedure   [ In-hospital ]
  Show Outcome Measure 26

27.  Secondary:   Proximal Late Loss   [ at 240 days ]
  Show Outcome Measure 27

28.  Secondary:   Distal Late Loss   [ 240 days ]
  Show Outcome Measure 28

29.  Secondary:   In-stent Late Loss   [ at 240 days ]
  Show Outcome Measure 29

30.  Secondary:   % Volume Obstruction (% VO)   [ at 240 days ]
  Show Outcome Measure 30

31.  Secondary:   In-stent % Diameter Stenosis (% DS)   [ at 240 days ]
  Show Outcome Measure 31

32.  Secondary:   In-segment % Diameter Stenosis (% DS)   [ 240 days ]
  Show Outcome Measure 32


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
XIENCE V® EECSS XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS® EXPRESS2™ ECSS TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.

Serious Adverse Events
  XIENCE V® EECSS TAXUS® EXPRESS2™ ECSS
Total, serious adverse events    
# participants affected 219   126  
Blood and lymphatic system disorders    
Anaemia   † A
      # participants affected / at risk
      # events
1/438 (0.23%)
3  
5/211 (2.37%)
6  
Thrombocytopenia   † A
      # participants affected / at risk
      # events
1/438 (0.23%)
2  
0/211 (0.00%)
0  
Cardiac disorders    
Acute coronary syndrome   † A
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
0/211 (0.00%)
0  
Acute myocardial infarction   † A
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Angina pectoris   † A
      # participants affected / at risk
      # events
42/438 (9.59%)
51  
37/211 (17.54%)
41  
Angina unstable   † A
      # participants affected / at risk
      # events
4/438 (0.91%)
4  
2/211 (0.95%)
2  
Arrhythmia   † A
      # participants affected / at risk
      # events
6/438 (1.37%)
7  
2/211 (0.95%)
4  
Arteriospasm coronary   † A
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Atrial fibrillation   † A
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
3/211 (1.42%)
3  
Atrial flutter   † A
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Atrioventricular block first degree   † A
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Bradycardia   † A
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
2/211 (0.95%)
2  
Cardiac failure congestive   † A
      # participants affected / at risk
      # events
6/438 (1.37%)
8  
6/211 (2.84%)
7  
Cardiorespiratory arrest   † A
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Chest pain   † A
      # participants affected / at risk
      # events
5/438 (1.14%)
5  
1/211 (0.47%)
1  
Cor pulmonale   † A
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Coronary artery disease   † A
      # participants affected / at risk
      # events
7/438 (1.60%)
7  
0/211 (0.00%)
0  
Coronary artery dissection   † A
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Coronary artery occlusion   † A
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
1/211 (0.47%)
1  
Coronary artery stenosis   † A
      # participants affected / at risk
      # events
7/438 (1.60%)
7  
3/211 (1.42%)
3  
Coronary artery thrombosis   † A
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Diastolic dysfunction   † A
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Instent coronary artery restenosis   † A
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Mitral valve incompetence   † A
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Myocardial infarction   † B
      # participants affected / at risk
      # events
11/438 (2.51%)
11  
10/211 (4.74%)
10  
Myocardial ischaemia   † B
      # participants affected / at risk
      # events
25/438 (5.71%)
27  
12/211 (5.69%)
15  
Sick sinus syndrome   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Supraventricular tachycardia   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
2  
Tachycardia   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Tachycardia paroxysmal   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Ventricular fibrillation   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Ventricular tachycardia   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Ischaemic cardiomyopathy   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Ear and labyrinth disorders    
Vertigo   † C
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Gastrointestinal disorders    
Abdominal pain   † B
      # participants affected / at risk
      # events
4/438 (0.91%)
4  
3/211 (1.42%)
3  
Abdominal pain lower   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Abdominal pain upper   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Appendicitis perforated   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Colonic obstruction   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Colonic polyp   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Diarrhoea   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
1/211 (0.47%)
1  
Dyspepsia   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
0/211 (0.00%)
0  
Gastric ulcer   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Gastritis erosive   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Gastroenteritis   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Gastrooesophageal reflux disease   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
2/211 (0.95%)
2  
Hiatus hernia   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Impaired gastric emptying   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Nausea   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Pancreatitis   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
0/211 (0.00%)
0  
Small intestinal obstruction   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Upper gastrointestinal haemorrhage   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Vomiting   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
2/211 (0.95%)
2  
Pyrexia   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
General disorders    
Adverse drug reaction   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
2/211 (0.95%)
2  
Catheter site haematoma   † B
      # participants affected / at risk
      # events
3/438 (0.68%)
3  
2/211 (0.95%)
2  
Catheter site haemorrhage   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Chest discomfort   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
3/211 (1.42%)
3  
Fatigue   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Hernia obstructive   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Noncardiac chest pain   † B
      # participants affected / at risk
      # events
16/438 (3.65%)
20  
11/211 (5.21%)
14  
Pain   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Hepatobiliary disorders    
Cholecystitis   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Cholecystitis acute   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Gallbladder disorder   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Infections and infestations    
Abscess limb   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Cellulitis   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Diverticulitis   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
1/211 (0.47%)
1  
Gastroenteritis viral   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Osteomyelitis   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Pneumonia   † B
      # participants affected / at risk
      # events
6/438 (1.37%)
6  
1/211 (0.47%)
1  
Pneumonia fungal   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Respiratory tract infection   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Staphylococcal infection   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Urinary tract infection   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Urosepsis   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Injury, poisoning and procedural complications    
Brain contusion   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Contusion   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Device dislocation   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Fall   † B
      # participants affected / at risk
      # events
3/438 (0.68%)
3  
1/211 (0.47%)
1  
Fracture   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Hip fracture   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Implantable defibrillator malfunction   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Injury   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Operative haemorrhage   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Overdose   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Road traffic accident   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Skin laceration   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Thrombosis in device   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Investigations    
Arteriogram coronary   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
2/211 (0.95%)
2  
Blood creatinine increased   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
2/211 (0.95%)
2  
Blood glucose increased   † B
      # participants affected / at risk
      # events
3/438 (0.68%)
3  
0/211 (0.00%)
0  
Blood pressure decreased   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Body temperature increased   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Cardiac enzymes increased   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
2/211 (0.95%)
2  
Cardiac stress test abnormal   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
1/211 (0.47%)
1  
Electrocardiogram abnormal   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Haemoglobin decreased   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Dehydration   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Metabolism and nutrition disorders    
Diabetes mellitus   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Fluid retention   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Gout   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Hyperglycaemia   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Hyperkalaemia   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Hypoglycaemia   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
2/211 (0.95%)
2  
Type 2 diabetes mellitus   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Musculoskeletal and connective tissue disorders    
Back pain   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Compartment syndrome   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Muscle spasms   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Osteoarthritis   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Colon cancer   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Lung neoplasm malignant   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Neoplasm malignant   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Oesophageal carcinoma   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
0/211 (0.00%)
0  
Prostate cancer   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Thymoma   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Nervous system disorders    
Carotid artery stenosis   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
2/211 (0.95%)
2  
Central nervous system lesion   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Cerebrovascular accident   † B
      # participants affected / at risk
      # events
4/438 (0.91%)
4  
1/211 (0.47%)
2  
Cervicobrachial syndrome   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Dementia   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Dizziness   † B
      # participants affected / at risk
      # events
4/438 (0.91%)
4  
0/211 (0.00%)
0  
Encephalopathy   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Headache   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Syncope   † B
      # participants affected / at risk
      # events
5/438 (1.14%)
6  
2/211 (0.95%)
2  
Transient ischaemic attack   † B
      # participants affected / at risk
      # events
3/438 (0.68%)
3  
1/211 (0.47%)
1  
Psychiatric disorders    
Acute psychosis   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Agitation   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Anxiety   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Depression   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Renal and urinary disorders    
Renal artery stenosis   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Renal disorder   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Renal failure   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
2/211 (0.95%)
4  
Renal failure acute   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Renal failure chronic   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
4  
Urinary retention   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
2/211 (0.95%)
2  
Reproductive system and breast disorders    
Benign prostatic hyperplasia   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Uterine prolapse   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Respiratory, thoracic and mediastinal disorders    
Chronic obstructive pulmonary disease   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
3  
1/211 (0.47%)
1  
Cough   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Dyspnoea   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
3/211 (1.42%)
3  
Dyspnoea exertional   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Lung disorder   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Pleural effusion   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Pleuritic pain   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Pulmonary embolism   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Sleep apnoea syndrome   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Skin and subcutaneous tissue disorders    
Eczema   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Social circumstances    
Physical disability   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Surgical and medical procedures    
Aortic aneurysm repair   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Aortic valve replacement   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Atherectomy   † B
      # participants affected / at risk
      # events
3/438 (0.68%)
3  
2/211 (0.95%)
2  
Breast lump removal   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Cardiac pacemaker replacement   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
0/211 (0.00%)
0  
Carotid endarterectomy   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
0/211 (0.00%)
0  
Cholecystectomy   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Colectomy   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Coronary angioplasty   † B
      # participants affected / at risk
      # events
9/438 (2.05%)
9  
9/211 (4.27%)
10  
Coronary arterial stent insertion   † B
      # participants affected / at risk
      # events
3/438 (0.68%)
3  
2/211 (0.95%)
2  
Coronary artery bypass graft   † B
      # participants affected / at risk
      # events
10/438 (2.28%)
28  
3/211 (1.42%)
5  
Coronary revascularisation   † B
      # participants affected / at risk
      # events
60/438 (13.70%)
94  
43/211 (20.38%)
68  
Implantable defibrillator replacement   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Knee arthroplasty   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Prostatectomy   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Renal artery stent placement   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Spinal operation   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
2/211 (0.95%)
2  
Thrombectomy   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Thyroidectomy   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Carotid artery stent insertion   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
1/211 (0.47%)
1  
Vascular disorders    
Aortic aneurysm   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Arterial thrombosis limb   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Deep vein thrombosis   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Femoral arterial stenosis   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Gastrointestinal haemorrhage   † D
      # participants affected / at risk
      # events
6/438 (1.37%)
6  
4/211 (1.90%)
4  
Hypertension   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
3/211 (1.42%)
3  
Hypotension   † B
      # participants affected / at risk
      # events
4/438 (0.91%)
4  
2/211 (0.95%)
2  
Iliact artery stenosis   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
0/211 (0.00%)
0  
Peripheral ischaemia   † B
      # participants affected / at risk
      # events
4/438 (0.91%)
4  
3/211 (1.42%)
3  
Peripheral vascular disorder   † B
      # participants affected / at risk
      # events
1/438 (0.23%)
1  
3/211 (1.42%)
3  
Phlebitis superficial   † B
      # participants affected / at risk
      # events
0/438 (0.00%)
0  
1/211 (0.47%)
1  
Retroperitoneal haemorrhage   † B
      # participants affected / at risk
      # events
2/438 (0.46%)
2  
0/211 (0.00%)
0  
Vascular pseudoaneurysm   † B
      # participants affected / at risk
      # events
5/438 (1.14%)
5  
3/211 (1.42%)
3  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 11
B Term from vocabulary, MedDRA 11.0
C Term from vocabulary, MedDRA 10.0
D Term from vocabulary, MedDRA 11,0


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Matt Kiely, Manager Medical Information
Organization: Abbott Vascular
phone: 408-845-3477
e-mail: matthew.kiely@av.abbott.com


Publications of Results:
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13.
Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial. Circulation. 2009 Feb 10;119(5):680-6. Epub 2009 Jan 26.
Lansky AJ, Ng VG, Mutlu H, Cristea E, Guiran JB, Midei M, Newman W, Sanz M, Sood P, Doostzadeh J, Su X, White R, Cao S, Sudhir K, Stone GW. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system:: clinical and angiographic results from the spirit III randomized trial. Catheter Cardiovasc Interv. 2009 Mar 24; [Epub ahead of print]


Responsible Party: Abbott Vascular ( Abbott Vascular )
Study ID Numbers: 03-360
Study First Received: September 13, 2005
Results First Received: October 15, 2008
Last Updated: September 18, 2009
ClinicalTrials.gov Identifier: NCT00180479     History of Changes
Health Authority: United States: Food and Drug Administration





Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services