Trial Outcomes & Findings for The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions (NCT NCT00814970)
NCT ID: NCT00814970
Last Updated: 2016-04-13
Results Overview
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
196 participants
Primary outcome timeframe
12 Months
Results posted on
2016-04-13
Participant Flow
Recruitment was for a period of 20 months. Subjects were recruited at medical clinics who participate in clinical trials.
Participant milestones
| Measure |
Complete Self-expanding (SE) Vascular Stent System
Device: Complete Self-expanding (SE) Vascular Stent System \>
\> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Overall Study
STARTED
|
196
|
|
Overall Study
COMPLETED
|
146
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions
Baseline characteristics by cohort
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System\>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
122 Participants
n=5 Participants
|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
133 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Intent-to-Treat Population
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Major Adverse Event (MAE) Rate
|
11.0 percentage of participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Intention-to-Treat (ITT)
Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Primary Patency Rate
|
72.6 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Intention-to-Treat (ITT)
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Major Adverse Event (MAE) Rate
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Intention-to-Treat (ITT)
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Major Adverse Event (MAE) Rate
|
4.1 percentage of participants
|
SECONDARY outcome
Timeframe: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).Population: Intention-to-Treat (ITT)
The outcome is based on the angiographic evidence of \<30% final residual stenosis of the target lesion using only the assigned device.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Device Success
|
90.0 percentage of lesions treated
|
SECONDARY outcome
Timeframe: At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).Population: Intention-to-Treat (ITT)
The outcome is based on the angiographic evidence of \<30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Lesion Success
|
90.0 percentage of lesions treated
|
SECONDARY outcome
Timeframe: At time of deployment to time of hospital dischargePopulation: Intention-to-Treat (ITT)
The outcome is based on the angiographic evidence of \<30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Procedure Success
|
89.1 percentage of lesions treated
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat (ITT)
Defined as vessel patency resulting from a procedure performed in the treated segment.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Assisted Primary Patency
|
78.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intention-to-Treat (ITT)
Defined as vessel patency resulting from any procedure that restores patency.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Secondary Patency Rate
|
78.9 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention-to-Treat (ITT)
Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category
|
90.9 percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intention-to-Treat (ITT)
Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15
|
64.5 percentage of participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Intention-to-Treat (ITT)
Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Change in Quality of Life - Decrease in Rutherford Class >= 1 Category
|
89.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intention-to-Treat (ITT)
Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=189 Stents implanted with x-ray follow-up
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Percentage of Participants Free From Strut Fractures
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intention-to-Treat (ITT)
Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI \>= 0.15
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Clinically-driven Target Lesion Revascularization (TLR) Rate
|
8.4 percentage of participants
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Intention-to-Treat
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Major Adverse Event (MAE) Rate
|
22.5 percentage of participants
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Intention-to-Treat (ITT)
Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=159 Stents implanted with x-ray follow-up
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Percentage of Participants Free From Strut Fractures
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: Intention-to-Treat
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=196 Participants
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Major Adverse Event (MAE) Rate
|
30.2 percentage of participants
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: Intention-to-Treat
Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint.
Outcome measures
| Measure |
Complete SE Vascular Stent System
n=159 Stents implanted with x-ray follow-up
Device: Complete SE Vascular Stent System \>
\> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Percentage of Participants Free From Strut Fractures
|
100.0 percentage of participants
|
Adverse Events
1. Complete SE Vascular Stent System
Serious events: 117 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1. Complete SE Vascular Stent System
n=196 participants at risk
Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
8/196 • Number of events 9 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.0%
4/196 • Number of events 4 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
2.0%
4/196 • Number of events 4 • 12 months
|
|
Cardiac disorders
Angina Unstable
|
1.5%
3/196 • Number of events 3 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
4/196 • Number of events 4 • 12 months
|
|
Cardiac disorders
Atrioventricular Block
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Failure
|
1.5%
3/196 • Number of events 4 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.5%
3/196 • Number of events 4 • 12 months
|
|
Cardiac disorders
Coronary Artery Disease
|
5.1%
10/196 • Number of events 10 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Cardiac disorders
Sick Sinus Syndrome
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Congenital, familial and genetic disorders
Gastrointestinal Angiodysplasia
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Eye disorders
Vitreous Haemorrhage
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Ascites
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Colitis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.5%
3/196 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Mesenteric Vein Thrombosis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
General disorders
Asthenia
|
0.51%
1/196 • Number of events 2 • 12 months
|
|
General disorders
Catheter Site Haemorrhage
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
General disorders
Chest Pain
|
4.6%
9/196 • Number of events 9 • 12 months
|
|
General disorders
Gait Disturbance
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
General disorders
Impaired Healing
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
General disorders
Pyrexia
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
General disorders
Wound Necrosis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.51%
1/196 • Number of events 2 • 12 months
|
|
Hepatobiliary disorders
Gallbladder Disorder
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Bronchitis
|
2.0%
4/196 • Number of events 4 • 12 months
|
|
Infections and infestations
Bronchopneumonia
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Cellulitis
|
2.0%
4/196 • Number of events 5 • 12 months
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Diverticulitis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Gangrene
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Infection
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Lobar Pneumonia
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Localised Infection
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Osteomyelitis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Osteomyelitis Acute
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
2.6%
5/196 • Number of events 5 • 12 months
|
|
Infections and infestations
Sepsis
|
2.6%
5/196 • Number of events 5 • 12 months
|
|
Infections and infestations
Subcutaneous Abscess
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
2/196 • Number of events 4 • 12 months
|
|
Infections and infestations
Wound Infection
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Device Electrical Finding
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
In-Stent Arterial Restenosis
|
7.1%
14/196 • Number of events 15 • 12 months
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Stent Occlusion
|
2.6%
5/196 • Number of events 5 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Gout
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.0%
2/196 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
3.6%
7/196 • Number of events 8 • 12 months
|
|
Nervous system disorders
Cerebral Infarction
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.51%
1/196 • Number of events 2 • 12 months
|
|
Nervous system disorders
Hemiparesis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Nervous system disorders
Presyncope
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Nervous system disorders
Spinal Claudication
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Depression
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Mental Status Changes
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Psychiatric disorders
Psychotic Disorder
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.0%
4/196 • Number of events 4 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/196 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Peripheral Revascularisation
|
1.5%
3/196 • Number of events 3 • 12 months
|
|
Surgical and medical procedures
Tendon Sheath Incision
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Wound Debridement
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Vascular disorders
Aneurysm
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Vascular disorders
Arterial Occlusive Disease
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Vascular disorders
Arterial Restenosis
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Vascular disorders
Arterial Stenosis
|
0.51%
1/196 • Number of events 3 • 12 months
|
|
Vascular disorders
Arterial Stenosis Limb
|
2.6%
5/196 • Number of events 5 • 12 months
|
|
Vascular disorders
Artery Dissection
|
3.6%
7/196 • Number of events 7 • 12 months
|
|
Vascular disorders
Femoral Arterial Stenosis
|
8.2%
16/196 • Number of events 17 • 12 months
|
|
Vascular disorders
Femoral Artery Occlusion
|
1.5%
3/196 • Number of events 3 • 12 months
|
|
Vascular disorders
Haematoma
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Vascular disorders
Intermittent Claudication
|
6.6%
13/196 • Number of events 15 • 12 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
1.0%
2/196 • Number of events 2 • 12 months
|
|
Vascular disorders
Peripheral Artery Dissection
|
1.5%
3/196 • Number of events 3 • 12 months
|
|
Vascular disorders
Peripheral Embolism
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral Ischaemia
|
1.5%
3/196 • Number of events 3 • 12 months
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.51%
1/196 • Number of events 1 • 12 months
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
0.51%
1/196 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
1. Complete SE Vascular Stent System
n=196 participants at risk
Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
|
|---|---|
|
General disorders
Chest Pain
|
6.1%
12/196 • Number of events 13 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.2%
16/196 • Number of events 16 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
7.7%
15/196 • Number of events 18 • 12 months
|
|
Vascular disorders
Intermittent Claudication
|
8.7%
17/196 • Number of events 17 • 12 months
|
Additional Information
Arslan Malik - Senior Clinical Research Manager
Medtronic Aortic and Peripheral Vascular
Phone: (707) 541-3256
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60