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The Medtronic RESOLUTE US Clinical Trial (R-US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00726453
Recruitment Status : Completed
First Posted : August 1, 2008
Results First Posted : May 25, 2012
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Intervention Device: Resolute Zotarolimus-Eluting Coronary Stent
Enrollment 1516
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Primary Enrollment Group 38 mm Length Sub-study
Hide Arm/Group Description

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:

2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.

Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
Period Title: Primary Enrollment Group
Started 1402 0
Completed 1371 0
Not Completed 31 0
Reason Not Completed
Death             18             0
Withdrawal by Subject             13             0
Period Title: 38 mm Length Group
Started 0 114
Completed 0 111 [1]
Not Completed 0 3
Reason Not Completed
Death             0             3
[1]
This sub-study completed the primary endpoint in March 2012 results not yet available.
Arm/Group Title Primary Enrollment Group 38 mm Length Sub-study Total
Hide Arm/Group Description

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:

2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.

Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed. This sub-study completed the primary endpoint in March 2012 results not yet available. Total of all reporting groups
Overall Number of Baseline Participants 1402 114 1516
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1402 participants 114 participants 1516 participants
64.1  (10.7) 64.8  (9.7) 64.5  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1402 participants 114 participants 1516 participants
Female
444
  31.7%
30
  26.3%
474
  31.3%
Male
958
  68.3%
84
  73.7%
1042
  68.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1402 participants 114 participants 1516 participants
1402 114 1516
1.Primary Outcome
Title Target Lesion Failure (TLF)
Hide Description Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Enrollment Group
Hide Arm/Group Description:

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:

2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.

Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).

Overall Number of Participants Analyzed 1376
Measure Type: Number
Unit of Measure: percentage of participants
4.7
2.Secondary Outcome
Title Target Vessel Failure (TVF)
Hide Description Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Enrollment Group
Hide Arm/Group Description:

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:

2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.

Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).

Overall Number of Participants Analyzed 1376
Measure Type: Number
Unit of Measure: percentage of participants
6.3
3.Secondary Outcome
Title Major Adverse Cardiac Event (MACE)
Hide Description Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Enrollment Group
Hide Arm/Group Description:

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:

2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.

Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).

Overall Number of Participants Analyzed 1376
Measure Type: Number
Unit of Measure: percentage of participants
5.5
4.Secondary Outcome
Title Death
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Enrollment Group
Hide Arm/Group Description:

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:

2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.

Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).

Overall Number of Participants Analyzed 1376
Measure Type: Number
Unit of Measure: percentage of participants
1.3
5.Secondary Outcome
Title Target Vessel MI
Hide Description Target Vessel MI (as determined by extended historical and ARC definitions).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Enrollment Group
Hide Arm/Group Description:

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:

2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.

Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).

Overall Number of Participants Analyzed 1376
Measure Type: Number
Unit of Measure: percentage of eligible participants
1.4
6.Secondary Outcome
Title Stent Thrombosis (ST)
Hide Description Stent Thrombosis (ST) (as determined by historic and ARC definitions).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Enrollment Group
Hide Arm/Group Description:

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:

2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.

Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG).

Overall Number of Participants Analyzed 1376
Measure Type: Number
Unit of Measure: percentage of participants
0.1
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Primary Enrollment Group 38 mm Length Sub-Study
Hide Arm/Group Description

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:

2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study and are collectively referred to as the Primary Enrollment Group (PEG).

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
All-Cause Mortality
Primary Enrollment Group 38 mm Length Sub-Study
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Primary Enrollment Group 38 mm Length Sub-Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   509/1402 (36.31%)      71/114 (62.28%)    
Blood and lymphatic system disorders     
Anaemia  12/1402 (0.86%)  16 0/114 (0.00%)  0
Coagulopathy  1/1402 (0.07%)  1 0/114 (0.00%)  0
Disseminated Intravascular Coagulation  1/1402 (0.07%)  1 0/114 (0.00%)  0
Leukocytosis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Lymphadenopathy  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cardiac disorders     
Acute Coronary Syndrome  3/1402 (0.21%)  3 0/114 (0.00%)  0
Acute Myocardial Infarction  21/1402 (1.50%)  21 3/114 (2.63%)  3
Angina Pectoris  68/1402 (4.85%)  83 6/114 (5.26%)  6
Angina Unstable  19/1402 (1.36%)  19 2/114 (1.75%)  2
Aortic Valve Stenosis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Arrhythmia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Arteriospasm Coronary  1/1402 (0.07%)  1 0/114 (0.00%)  0
Atrial Fibrillation  17/1402 (1.21%)  20 2/114 (1.75%)  3
Atrial Flutter  3/1402 (0.21%)  3 0/114 (0.00%)  0
Atrioventricular Block Complete  1/1402 (0.07%)  1 0/114 (0.00%)  0
Bradycardia  2/1402 (0.14%)  2 1/114 (0.88%)  1
Cardiac Arrest  1/1402 (0.07%)  1 1/114 (0.88%)  1
Cardiac Failure  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cardiac Failure Congestive  18/1402 (1.28%)  21 3/114 (2.63%)  7
Cardiac Valve Disease  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cardio-Respiratory Arrest  2/1402 (0.14%)  2 0/114 (0.00%)  0
Cardiogenic Shock  1/1402 (0.07%)  1 0/114 (0.00%)  0
Coronary Artery Disease  56/1402 (3.99%)  60 11/114 (9.65%)  12
Coronary Artery Dissection  13/1402 (0.93%)  13 7/114 (6.14%)  7
Coronary Artery Embolism  0/1402 (0.00%)  0 2/114 (1.75%)  2
Coronary Artery Occlusion  2/1402 (0.14%)  2 1/114 (0.88%)  1
Coronary Artery Perforation  0/1402 (0.00%)  0 1/114 (0.88%)  1
Coronary Artery Restenosis  12/1402 (0.86%)  12 2/114 (1.75%)  2
Coronary Artery Stenosis  13/1402 (0.93%)  14 1/114 (0.88%)  1
In-Stent Coronary Artery Restenosis  13/1402 (0.93%)  14 0/114 (0.00%)  0
Ischaemic Cardiomyopathy  2/1402 (0.14%)  2 1/114 (0.88%)  1
Myocardial Infarction  7/1402 (0.50%)  7 2/114 (1.75%)  2
Myocardial Ischaemia  0/1402 (0.00%)  0 1/114 (0.88%)  1
Palpitations  1/1402 (0.07%)  1 1/114 (0.88%)  1
Pericarditis  3/1402 (0.21%)  3 0/114 (0.00%)  0
Sick Sinus Syndrome  3/1402 (0.21%)  3 0/114 (0.00%)  0
Supraventricular Tachycardia  4/1402 (0.29%)  5 0/114 (0.00%)  0
Tachycardia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Ventricular Arrhythmia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Ventricular Fibrillation  4/1402 (0.29%)  4 0/114 (0.00%)  0
Ventricular Tachycardia  3/1402 (0.21%)  3 1/114 (0.88%)  1
Congenital, familial and genetic disorders     
Arteriovenous Malformation  1/1402 (0.07%)  1 0/114 (0.00%)  0
Atrial Septal Defect  1/1402 (0.07%)  1 0/114 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  2/1402 (0.14%)  2 0/114 (0.00%)  0
Endocrine disorders     
Hyperparathyroidism Primary  1/1402 (0.07%)  1 0/114 (0.00%)  0
Eye disorders     
Amaurosis Fugax  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cataract  0/1402 (0.00%)  0 3/114 (2.63%)  5
Conjunctivitis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Eye Swelling  1/1402 (0.07%)  1 0/114 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain  10/1402 (0.71%)  13 1/114 (0.88%)  1
Abdominal Pain Upper  1/1402 (0.07%)  1 0/114 (0.00%)  0
Barrett's Oesophagus  0/1402 (0.00%)  0 1/114 (0.88%)  1
Colitis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Colitis Ischaemic  2/1402 (0.14%)  2 0/114 (0.00%)  0
Constipation  1/1402 (0.07%)  2 0/114 (0.00%)  0
Diarrhoea  1/1402 (0.07%)  1 0/114 (0.00%)  0
Dyspepsia  0/1402 (0.00%)  0 1/114 (0.88%)  1
Gastritis  2/1402 (0.14%)  2 0/114 (0.00%)  0
Gastrointestinal Haemorrhage  21/1402 (1.50%)  23 1/114 (0.88%)  1
Gastrooesophageal Reflux Disease  1/1402 (0.07%)  1 0/114 (0.00%)  0
Haematemesis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hiatus Hernia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Ileus  1/1402 (0.07%)  1 0/114 (0.00%)  0
Intestinal Ischaemia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Intestinal Obstruction  3/1402 (0.21%)  4 1/114 (0.88%)  1
Large Intestinal Haemorrhage  1/1402 (0.07%)  1 0/114 (0.00%)  0
Large Intestine Perforation  1/1402 (0.07%)  1 0/114 (0.00%)  0
Pancreatitis  2/1402 (0.14%)  2 0/114 (0.00%)  0
Pancreatitis Acute  2/1402 (0.14%)  2 0/114 (0.00%)  0
Pancreatitis Chronic  1/1402 (0.07%)  1 0/114 (0.00%)  0
Pancreatitis Necrotising  1/1402 (0.07%)  1 0/114 (0.00%)  0
Rectal Haemorrhage  2/1402 (0.14%)  5 0/114 (0.00%)  0
Retroperitoneal Haemorrhage  3/1402 (0.21%)  4 0/114 (0.00%)  0
Small Intestinal Obstruction  2/1402 (0.14%)  2 0/114 (0.00%)  0
Splenic Artery Aneurysm  1/1402 (0.07%)  1 0/114 (0.00%)  0
Vomiting  3/1402 (0.21%)  3 0/114 (0.00%)  0
General disorders     
Adverse Drug Reaction  1/1402 (0.07%)  1 0/114 (0.00%)  0
Asthenia  2/1402 (0.14%)  2 0/114 (0.00%)  0
Catheter Site Haemorrhage  2/1402 (0.14%)  2 0/114 (0.00%)  0
Chest Discomfort  7/1402 (0.50%)  8 0/114 (0.00%)  0
Chest Pain  79/1402 (5.63%)  98 7/114 (6.14%)  7
Death  2/1402 (0.14%)  2 1/114 (0.88%)  1
Fatigue  2/1402 (0.14%)  2 0/114 (0.00%)  0
Granuloma  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hernia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Implant Site Effusion  1/1402 (0.07%)  1 0/114 (0.00%)  0
Injection Site Haematoma  2/1402 (0.14%)  2 1/114 (0.88%)  1
Injection Site Haemorrhage  1/1402 (0.07%)  1 0/114 (0.00%)  0
Mass  2/1402 (0.14%)  2 0/114 (0.00%)  0
Multi-Organ Failure  1/1402 (0.07%)  1 0/114 (0.00%)  0
Non-Cardiac Chest Pain  32/1402 (2.28%)  39 1/114 (0.88%)  1
Pain  1/1402 (0.07%)  1 0/114 (0.00%)  0
Systemic Inflammatory Response Syndrome  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hepatobiliary disorders     
Biliary Colic  2/1402 (0.14%)  2 0/114 (0.00%)  0
Cholangitis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cholecystitis  3/1402 (0.21%)  3 1/114 (0.88%)  1
Cholecystitis Acute  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cholelithiasis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cholestasis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Gallbladder Disorder  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hepatic Failure  1/1402 (0.07%)  1 0/114 (0.00%)  0
Ischaemic Hepatitis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Immune system disorders     
Anaphylactic Reaction  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hypersensitivity  1/1402 (0.07%)  1 0/114 (0.00%)  0
Infections and infestations     
Abscess Limb  1/1402 (0.07%)  1 0/114 (0.00%)  0
Abscess Neck  1/1402 (0.07%)  1 0/114 (0.00%)  0
Appendicitis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Bronchitis  3/1402 (0.21%)  3 0/114 (0.00%)  0
Bronchopneumonia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Catheter Site Infection  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cellulitis  3/1402 (0.21%)  3 0/114 (0.00%)  0
Cellulitis Staphylococcal  1/1402 (0.07%)  1 0/114 (0.00%)  0
Clostridial Infection  1/1402 (0.07%)  1 0/114 (0.00%)  0
Clostridium Difficile Colitis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Diverticulitis  5/1402 (0.36%)  8 0/114 (0.00%)  0
Endocarditis Bacterial  1/1402 (0.07%)  2 0/114 (0.00%)  0
Escherichia Bacteraemia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Gastroenteritis  2/1402 (0.14%)  2 0/114 (0.00%)  0
Gastroenteritis Viral  1/1402 (0.07%)  1 0/114 (0.00%)  0
Infection  9/1402 (0.64%)  13 0/114 (0.00%)  0
Liver Abscess  1/1402 (0.07%)  1 0/114 (0.00%)  0
Perirectal Abscess  1/1402 (0.07%)  1 0/114 (0.00%)  0
Pneumonia  20/1402 (1.43%)  20 2/114 (1.75%)  2
Pyelonephritis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Sepsis  2/1402 (0.14%)  2 0/114 (0.00%)  0
Septic Shock  2/1402 (0.14%)  2 0/114 (0.00%)  0
Staphylococcal Bacteraemia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Staphylococcal Infection  1/1402 (0.07%)  1 0/114 (0.00%)  0
Syphilitic Endocarditis Of Heart Valve  1/1402 (0.07%)  1 0/114 (0.00%)  0
Urinary Tract Infection  4/1402 (0.29%)  4 0/114 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle Fracture  1/1402 (0.07%)  1 0/114 (0.00%)  0
Arteriovenous Graft Thrombosis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Contusion  0/1402 (0.00%)  0 1/114 (0.88%)  1
Excoriation  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hand Fracture  2/1402 (0.14%)  2 0/114 (0.00%)  0
Injury  0/1402 (0.00%)  0 1/114 (0.88%)  1
Meniscus Lesion  2/1402 (0.14%)  2 0/114 (0.00%)  0
Multiple Fractures  1/1402 (0.07%)  1 1/114 (0.88%)  1
Overdose  1/1402 (0.07%)  1 0/114 (0.00%)  0
Road Traffic Accident  1/1402 (0.07%)  1 0/114 (0.00%)  0
Spinal Fracture  2/1402 (0.14%)  2 0/114 (0.00%)  0
Stent Occlusion  1/1402 (0.07%)  1 0/114 (0.00%)  0
Sternal Fracture  1/1402 (0.07%)  1 0/114 (0.00%)  0
Subdural Haematoma  0/1402 (0.00%)  0 1/114 (0.88%)  1
Therapeutic Agent Toxicity  1/1402 (0.07%)  1 0/114 (0.00%)  0
Thrombosis In Device  2/1402 (0.14%)  2 0/114 (0.00%)  0
Upper Limb Fracture  1/1402 (0.07%)  1 0/114 (0.00%)  0
Urethral Injury  1/1402 (0.07%)  1 0/114 (0.00%)  0
Investigations     
Blood Creatine Phosphokinase Mb Increased  2/1402 (0.14%)  2 0/114 (0.00%)  0
Blood Creatinine Increased  2/1402 (0.14%)  2 0/114 (0.00%)  0
Blood Glucose Increased  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cardiac Enzymes Increased  7/1402 (0.50%)  7 3/114 (2.63%)  3
Cardiac Stress Test Abnormal  2/1402 (0.14%)  2 0/114 (0.00%)  0
Ejection Fraction Decreased  1/1402 (0.07%)  1 0/114 (0.00%)  0
Troponin T Increased  0/1402 (0.00%)  0 1/114 (0.88%)  1
Metabolism and nutrition disorders     
Dehydration  3/1402 (0.21%)  3 0/114 (0.00%)  0
Diabetes Mellitus Inadequate Control  3/1402 (0.21%)  5 0/114 (0.00%)  0
Fluid Overload  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hypercalcaemia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hyperglycaemia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hyperkalaemia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hypoglycaemia  1/1402 (0.07%)  1 1/114 (0.88%)  1
Hyponatraemia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hypovolaemia  2/1402 (0.14%)  2 0/114 (0.00%)  0
Metabolic Acidosis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Obesity  2/1402 (0.14%)  2 0/114 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  4/1402 (0.29%)  4 0/114 (0.00%)  0
Arthritis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Arthropathy  1/1402 (0.07%)  1 0/114 (0.00%)  0
Back Pain  2/1402 (0.14%)  2 0/114 (0.00%)  0
Bone Lesion  1/1402 (0.07%)  1 0/114 (0.00%)  0
Flank Pain  1/1402 (0.07%)  1 0/114 (0.00%)  0
Intervertebral Disc Protrusion  2/1402 (0.14%)  2 0/114 (0.00%)  0
Muscular Weakness  0/1402 (0.00%)  0 1/114 (0.88%)  1
Musculoskeletal Chest Pain  1/1402 (0.07%)  1 0/114 (0.00%)  0
Musculoskeletal Pain  2/1402 (0.14%)  2 0/114 (0.00%)  0
Osteoarthritis  11/1402 (0.78%)  12 0/114 (0.00%)  0
Pain In Extremity  3/1402 (0.21%)  3 0/114 (0.00%)  0
Pain In Jaw  1/1402 (0.07%)  1 0/114 (0.00%)  0
Spinal Osteoarthritis  0/1402 (0.00%)  0 1/114 (0.88%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Cancer  2/1402 (0.14%)  2 0/114 (0.00%)  0
Brain Neoplasm  1/1402 (0.07%)  1 0/114 (0.00%)  0
Breast Cancer  3/1402 (0.21%)  3 0/114 (0.00%)  0
Bronchioloalveolar Carcinoma  1/1402 (0.07%)  1 0/114 (0.00%)  0
Choroid Melanoma  1/1402 (0.07%)  1 0/114 (0.00%)  0
Colon Cancer  2/1402 (0.14%)  2 0/114 (0.00%)  0
Lung Adenocarcinoma  1/1402 (0.07%)  1 0/114 (0.00%)  0
Lung Neoplasm  1/1402 (0.07%)  1 0/114 (0.00%)  0
Lung Neoplasm Malignant  3/1402 (0.21%)  3 0/114 (0.00%)  0
Lymphoma  1/1402 (0.07%)  1 0/114 (0.00%)  0
Metastatic Neoplasm  1/1402 (0.07%)  1 0/114 (0.00%)  0
Myelodysplastic Syndrome  1/1402 (0.07%)  1 0/114 (0.00%)  0
Myeloproliferative Disorder  1/1402 (0.07%)  1 0/114 (0.00%)  0
Prostate Cancer  4/1402 (0.29%)  4 0/114 (0.00%)  0
Prostate Cancer Metastatic  1/1402 (0.07%)  1 0/114 (0.00%)  0
Renal Cell Carcinoma Stage Unspecified  1/1402 (0.07%)  1 0/114 (0.00%)  0
Small Cell Lung Cancer Stage Unspecified  1/1402 (0.07%)  1 0/114 (0.00%)  0
Tongue Neoplasm Malignant Stage Unspecified  1/1402 (0.07%)  1 0/114 (0.00%)  0
Tonsil Cancer  1/1402 (0.07%)  1 0/114 (0.00%)  0
Nervous system disorders     
Carotid Artery Stenosis  13/1402 (0.93%)  14 0/114 (0.00%)  0
Cerebral Haemorrhage  1/1402 (0.07%)  1 0/114 (0.00%)  0
Cerebrovascular Accident  14/1402 (1.00%)  14 1/114 (0.88%)  1
Cervical Myelopathy  1/1402 (0.07%)  1 0/114 (0.00%)  0
Dizziness  1/1402 (0.07%)  1 0/114 (0.00%)  0
Encephalopathy  1/1402 (0.07%)  1 0/114 (0.00%)  0
Haemorrhage Intracranial  1/1402 (0.07%)  1 0/114 (0.00%)  0
Headache  2/1402 (0.14%)  4 0/114 (0.00%)  0
Hydrocephalus  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hypoaesthesia  2/1402 (0.14%)  2 0/114 (0.00%)  0
Lethargy  0/1402 (0.00%)  0 1/114 (0.88%)  1
Nerve Compression  1/1402 (0.07%)  1 0/114 (0.00%)  0
Presyncope  4/1402 (0.29%)  4 0/114 (0.00%)  0
Syncope  9/1402 (0.64%)  10 3/114 (2.63%)  3
Syncope Vasovagal  1/1402 (0.07%)  1 0/114 (0.00%)  0
Transient Ischaemic Attack  5/1402 (0.36%)  6 1/114 (0.88%)  2
Psychiatric disorders     
Anxiety  1/1402 (0.07%)  1 0/114 (0.00%)  0
Completed Suicide  1/1402 (0.07%)  1 0/114 (0.00%)  0
Confusional State  1/1402 (0.07%)  1 0/114 (0.00%)  0
Mental Status Changes  2/1402 (0.14%)  2 1/114 (0.88%)  1
Renal and urinary disorders     
Bladder Neck Sclerosis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Bladder Obstruction  1/1402 (0.07%)  1 0/114 (0.00%)  0
Haematuria  7/1402 (0.50%)  7 0/114 (0.00%)  0
Haemorrhage Urinary Tract  1/1402 (0.07%)  1 0/114 (0.00%)  0
Nephrolithiasis  4/1402 (0.29%)  4 0/114 (0.00%)  0
Nephrotic Syndrome  0/1402 (0.00%)  0 1/114 (0.88%)  1
Renal Artery Stenosis  2/1402 (0.14%)  2 0/114 (0.00%)  0
Renal Failure  11/1402 (0.78%)  11 1/114 (0.88%)  1
Renal Failure Acute  1/1402 (0.07%)  1 1/114 (0.88%)  1
Renal Mass  1/1402 (0.07%)  1 0/114 (0.00%)  0
Reproductive system and breast disorders     
Uterine Haemorrhage  1/1402 (0.07%)  1 0/114 (0.00%)  0
Uterine Prolapse  1/1402 (0.07%)  1 0/114 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome  2/1402 (0.14%)  2 0/114 (0.00%)  0
Acute Respiratory Failure  2/1402 (0.14%)  2 0/114 (0.00%)  0
Asthma  2/1402 (0.14%)  2 0/114 (0.00%)  0
Chronic Obstructive Pulmonary Disease  10/1402 (0.71%)  10 2/114 (1.75%)  3
Cough  2/1402 (0.14%)  2 0/114 (0.00%)  0
Dyspnoea  19/1402 (1.36%)  20 1/114 (0.88%)  1
Dyspnoea Exertional  2/1402 (0.14%)  2 0/114 (0.00%)  0
Epistaxis  2/1402 (0.14%)  2 0/114 (0.00%)  0
Pleural Effusion  3/1402 (0.21%)  3 0/114 (0.00%)  0
Pneumothorax  1/1402 (0.07%)  1 0/114 (0.00%)  0
Pulmonary Embolism  2/1402 (0.14%)  2 0/114 (0.00%)  0
Pulmonary Mass  1/1402 (0.07%)  1 0/114 (0.00%)  0
Respiratory Failure  3/1402 (0.21%)  3 1/114 (0.88%)  1
Skin and subcutaneous tissue disorders     
Hypoaesthesia Facial  1/1402 (0.07%)  1 0/114 (0.00%)  0
Skin Atrophy  1/1402 (0.07%)  1 0/114 (0.00%)  0
Skin Lesion  1/1402 (0.07%)  1 0/114 (0.00%)  0
Surgical and medical procedures     
Carotid Endarterectomy  1/1402 (0.07%)  1 0/114 (0.00%)  0
Coronary Revascularisation  6/1402 (0.43%)  7 1/114 (0.88%)  1
Hip Arthroplasty  1/1402 (0.07%)  1 0/114 (0.00%)  0
Hysterosalpingo-Oophorectomy  1/1402 (0.07%)  1 0/114 (0.00%)  0
Knee Arthroplasty  1/1402 (0.07%)  1 0/114 (0.00%)  0
Medical Device Implantation  1/1402 (0.07%)  1 0/114 (0.00%)  0
Renal Artery Stent Placement  1/1402 (0.07%)  1 0/114 (0.00%)  0
Therapeutic Embolisation  1/1402 (0.07%)  1 1/114 (0.88%)  1
Vascular disorders     
Accelerated Hypertension  1/1402 (0.07%)  1 0/114 (0.00%)  0
Aneurysm  1/1402 (0.07%)  1 0/114 (0.00%)  0
Aortic Aneurysm  3/1402 (0.21%)  3 0/114 (0.00%)  0
Arterial Stenosis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Arterial Stenosis Limb  1/1402 (0.07%)  2 0/114 (0.00%)  0
Arteriovenous Fistula  0/1402 (0.00%)  0 1/114 (0.88%)  1
Artery Dissection  1/1402 (0.07%)  1 0/114 (0.00%)  0
Deep Vein Thrombosis  2/1402 (0.14%)  3 0/114 (0.00%)  0
Femoral Arterial Stenosis  3/1402 (0.21%)  5 0/114 (0.00%)  0
Femoral Artery Occlusion  2/1402 (0.14%)  2 0/114 (0.00%)  0
Haemorrhage  3/1402 (0.21%)  3 2/114 (1.75%)  2
Hypertension  13/1402 (0.93%)  14 1/114 (0.88%)  1
Hypotension  12/1402 (0.86%)  12 0/114 (0.00%)  0
Iliac Artery Stenosis  2/1402 (0.14%)  2 0/114 (0.00%)  0
Intermittent Claudication  6/1402 (0.43%)  7 1/114 (0.88%)  1
Ischaemia  1/1402 (0.07%)  1 0/114 (0.00%)  0
Peripheral Artery Aneurysm  1/1402 (0.07%)  1 0/114 (0.00%)  0
Peripheral Ischaemia  3/1402 (0.21%)  7 1/114 (0.88%)  1
Peripheral Vascular Disorder  7/1402 (0.50%)  8 2/114 (1.75%)  2
Poor Peripheral Circulation  1/1402 (0.07%)  1 0/114 (0.00%)  0
Shock  1/1402 (0.07%)  1 0/114 (0.00%)  0
Subclavian Steal Syndrome  1/1402 (0.07%)  1 0/114 (0.00%)  0
Thrombosis  1/1402 (0.07%)  1 0/114 (0.00%)  0
Vascular Pseudoaneurysm  3/1402 (0.21%)  4 0/114 (0.00%)  0
Venous Insufficiency  0/1402 (0.00%)  0 1/114 (0.88%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Primary Enrollment Group 38 mm Length Sub-Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   724/1402 (51.64%)      67/114 (58.77%)    
Cardiac disorders     
Angina Pectoris  171/1402 (12.20%)  212 16/114 (14.04%)  20
Gastrointestinal disorders     
Nausea  0/1402 (0.00%)  0 10/114 (8.77%)  10
General disorders     
Chest Pain  204/1402 (14.55%)  256 23/114 (20.18%)  32
Fatigue  0/1402 (0.00%)  0 8/114 (7.02%)  8
Non-Cardiac Chest Pain  0/1402 (0.00%)  0 10/114 (8.77%)  11
Oedema  0/1402 (0.00%)  0 6/114 (5.26%)  6
Oedema Peripheral  0/1402 (0.00%)  0 9/114 (7.89%)  11
Musculoskeletal and connective tissue disorders     
Back Pain  92/1402 (6.56%)  99 0/114 (0.00%)  0
Pain In Extremity  77/1402 (5.49%)  81 17/114 (14.91%)  18
Nervous system disorders     
Dizziness  74/1402 (5.28%)  79 8/114 (7.02%)  9
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  106/1402 (7.56%)  113 13/114 (11.40%)  15
Vascular disorders     
Hypertension  0/1402 (0.00%)  0 14/114 (12.28%)  15
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: K. Bogdanovich
Organization: Medtronic Vascular
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00726453     History of Changes
Other Study ID Numbers: IP102
First Submitted: July 30, 2008
First Posted: August 1, 2008
Results First Submitted: January 31, 2012
Results First Posted: May 25, 2012
Last Update Posted: May 23, 2016