Trial Outcomes & Findings for BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease (NCT NCT02228564)
NCT ID: NCT02228564
Last Updated: 2020-10-08
Results Overview
The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
155 participants
Primary outcome timeframe
9 months post index procedure
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
LIFESTREAM™
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Overall Study
STARTED
|
155
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
LIFESTREAM™
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Death
|
11
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Lost to Follow-up
|
17
|
|
Overall Study
Other
|
6
|
Baseline Characteristics
BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
Baseline characteristics by cohort
| Measure |
LIFESTREAM™
n=155 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Age, Continuous
|
64.3 Years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
150 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
21 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
77 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 months post index procedurePopulation: The number of participants (n) may vary from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.
Outcome measures
| Measure |
LIFESTREAM™
n=138 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Participants With Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure.
|
16 Participants
|
SECONDARY outcome
Timeframe: 9 months post index procedurePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
Major Adverse Events (MAE) defined as device and/or procedure-related death or MI through 30 days, or any TLR or target limb(s) major amputation through 9-months post-index procedure. Major amputation is defined as an amputation at or above the ankle.
Outcome measures
| Measure |
LIFESTREAM™
n=150 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.
|
7 Participants
|
SECONDARY outcome
Timeframe: At time of Index ProcedureAcute Lesion Success defined as attainment of \< 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation), as determined by an Independent Angiographic Core Lab.
Outcome measures
| Measure |
LIFESTREAM™
n=191 Lesions
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Lesions With Acute Lesion Success
|
188 Lesions
|
SECONDARY outcome
Timeframe: At time of hospital dischargePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. In this instance, three subjects did not have procedure angiography data.
Acute Procedure Success defined as lesion success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
Outcome measures
| Measure |
LIFESTREAM™
n=152 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Participants With Acute Procedure Success
|
148 Participants
|
SECONDARY outcome
Timeframe: At time of index procedureAcute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator.
Outcome measures
| Measure |
LIFESTREAM™
n=230 Devices
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Devices With Acute Technical Success at Index Procedure
|
226 Devices
|
SECONDARY outcome
Timeframe: 6, 9, 12, 24, and 36 months post index procedurePopulation: The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.
Target Lesion Revascularization (TLR) is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Lesion Revascularizations (TLR) were Target Vessel Revascularizations (TVR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.
Outcome measures
| Measure |
LIFESTREAM™
n=155 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
6 months post index procedure
|
3 Participants
|
|
Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
9 months post index procedure
|
5 Participants
|
|
Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
12 months post index procedure
|
7 Participants
|
|
Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
24 months post index procedure
|
19 Participants
|
|
Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
36 Months Post Index Procedure
|
23 Participants
|
SECONDARY outcome
Timeframe: 6, 9, 12, 24, and 36 months post index procedurePopulation: The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.
Target Vessel Revascularization (TVR) is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Vessel Revascularizations (TVR) were Target Lesion Revascularizations (TLR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.
Outcome measures
| Measure |
LIFESTREAM™
n=155 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
6 months post index procedure
|
3 Participants
|
|
Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
9 months post index procedure
|
5 Participants
|
|
Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
12 months post index procedure
|
7 Participants
|
|
Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
24 months post index procedure
|
19 Participants
|
|
Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
36 Months Post Index Procedure
|
23 Participants
|
SECONDARY outcome
Timeframe: 30 days, and 9, 12, 24, and 36 months post index procedurePopulation: The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.
Sustained Clinical Success defined as sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category23 at 30-days and 9, 12, 24, and 36-months post-index procedure, as determined by the Investigator.
Outcome measures
| Measure |
LIFESTREAM™
n=155 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
30 days post index procedure
|
133 Participants
|
|
Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
9 months post index procedure
|
124 Participants
|
|
Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
12 months post index procedure
|
124 Participants
|
|
Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
24 months post index procedure
|
106 Participants
|
|
Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
36 months post index procedure
|
98 Participants
|
SECONDARY outcome
Timeframe: 9, 12, 24 and 36 months post index procedurePopulation: The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.
Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR ≤ 2.4.
Outcome measures
| Measure |
LIFESTREAM™
n=155 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
9 months post index procedure
|
118 Participants
|
|
Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
12 months post index procedure
|
110 Participants
|
|
Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
24 months post index procedure
|
92 Participants
|
|
Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
36 months post index procedure
|
72 Participants
|
SECONDARY outcome
Timeframe: 9, 12, 24, and 36 months post index procedurePopulation: The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.
Primary Assisted Patency at 9-, 12-, 24-, and 36-months post-index procedure corresponding to PSVR ≤ 2.4, as determined by an Independent DUS Core Lab. Primary Assisted Patency is independent of whether or not patency is re-established via an endovascular procedure following restenosis.
Outcome measures
| Measure |
LIFESTREAM™
n=155 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
9 months post index procedure
|
119 Participants
|
|
Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
12 months post index procedure
|
112 Participants
|
|
Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
24 months post index procedure
|
98 Participants
|
|
Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
36 months post index procedure
|
78 Participants
|
SECONDARY outcome
Timeframe: 9,12, 24, and 36 months post index procedurePopulation: The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.
Secondary Patency is a measure of success at re-establishing patency following failure of the initial stent placement due to stenosis or re-occlusion. In this study, Secondary Patency was independent of whether or not patency was re-established via an endovascular procedure following restenosis or occlusion, and was analyzed for the Intent to Treat (ITT) population. Secondary patency is defined as a peak systolic velocity ratio (PSVR) ≤ 2.4, as determined by an independent Duplex Ultrasonography (DUS) Core Lab.
Outcome measures
| Measure |
LIFESTREAM™
n=137 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.
9 months post index procedure
|
121 Participants
|
|
Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.
12 months post index procedure
|
112 Participants
|
|
Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.
24 months post index procedure
|
100 Participants
|
|
Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.
36 months post index procedure
|
79 Participants
|
SECONDARY outcome
Timeframe: 30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline.Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days,9, 12, 24, and 36 months compared to baseline assessment scores.
Outcome measures
| Measure |
LIFESTREAM™
n=155 Participants
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
30-days Post Index Procedure
|
31.45 Score on a scale
Standard Deviation 25.23
|
|
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
9 months post index procedure
|
32.10 Score on a scale
Standard Deviation 26.84
|
|
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
12 months post index procedure
|
32.81 Score on a scale
Standard Deviation 26.75
|
|
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
24 months post index procedure
|
31.34 Score on a scale
Standard Deviation 26.77
|
|
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
36 Months Post Index Procedure
|
32.52 Score on a scale
Standard Deviation 27.27
|
Adverse Events
LIFESTREAM™
Serious events: 60 serious events
Other events: 134 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
LIFESTREAM™
n=155 participants at risk
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
3/155
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.65%
1/155
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
1/155
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.65%
1/155
|
|
Cardiac disorders
Acute Myocardial Infarction
|
3.2%
5/155
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.65%
1/155
|
|
Cardiac disorders
Atrial Fibrillation
|
3.2%
5/155
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.65%
1/155
|
|
Cardiac disorders
Bradycardia
|
0.65%
1/155
|
|
Cardiac disorders
Cardiac Arrest
|
1.3%
2/155
|
|
Cardiac disorders
Cardiac Failure
|
1.3%
2/155
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.6%
4/155
|
|
Cardiac disorders
Cardiogenic Shock
|
0.65%
1/155
|
|
Cardiac disorders
Cardiomyopathy
|
0.65%
1/155
|
|
Cardiac disorders
Coronary Artery Disease
|
1.9%
3/155
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.65%
1/155
|
|
Cardiac disorders
Myocardial Infarction
|
0.65%
1/155
|
|
Cardiac disorders
Pericardial Effusion
|
0.65%
1/155
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.65%
1/155
|
|
Ear and labyrinth disorders
Vestibular Disorder
|
0.65%
1/155
|
|
Eye disorders
Cataract
|
0.65%
1/155
|
|
Eye disorders
Retinal Vein Thrombosis
|
0.65%
1/155
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.65%
1/155
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.65%
1/155
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.65%
1/155
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.9%
3/155
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.65%
1/155
|
|
Gastrointestinal disorders
Pancreatitis
|
0.65%
1/155
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.65%
1/155
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.65%
1/155
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.3%
2/155
|
|
General disorders
Adverse Drug Reaction
|
0.65%
1/155
|
|
General disorders
Chest Pain
|
0.65%
1/155
|
|
General disorders
Death
|
0.65%
1/155
|
|
General disorders
Device Occlusion
|
5.2%
8/155
|
|
General disorders
Non-Cardiac Chest Pain
|
0.65%
1/155
|
|
General disorders
Thrombosis In Device
|
1.3%
2/155
|
|
General disorders
Vessel Puncture Site Bruise
|
0.65%
1/155
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.65%
1/155
|
|
Hepatobiliary disorders
Gallbladder Perforation
|
0.65%
1/155
|
|
Infections and infestations
Bacteraemia
|
0.65%
1/155
|
|
Infections and infestations
Bronchopneumonia
|
0.65%
1/155
|
|
Infections and infestations
Cellulitis
|
0.65%
1/155
|
|
Infections and infestations
Cholecystitis Infective
|
0.65%
1/155
|
|
Infections and infestations
Diverticulitis
|
1.3%
2/155
|
|
Infections and infestations
Gangrene
|
0.65%
1/155
|
|
Infections and infestations
Groin Abscess
|
0.65%
1/155
|
|
Infections and infestations
Haematoma Infection
|
0.65%
1/155
|
|
Infections and infestations
Infection
|
0.65%
1/155
|
|
Infections and infestations
Kidney Infection
|
0.65%
1/155
|
|
Infections and infestations
Osteomyelitis
|
0.65%
1/155
|
|
Infections and infestations
Perirectal Abscess
|
0.65%
1/155
|
|
Infections and infestations
Pneumonia
|
0.65%
1/155
|
|
Infections and infestations
Pyelonephritis
|
0.65%
1/155
|
|
Infections and infestations
Scrotal Abscess
|
0.65%
1/155
|
|
Infections and infestations
Sepsis
|
0.65%
1/155
|
|
Infections and infestations
Septic Shock
|
0.65%
1/155
|
|
Infections and infestations
Subcutaneous Abscess
|
0.65%
1/155
|
|
Infections and infestations
Urosepsis
|
1.9%
3/155
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.65%
1/155
|
|
Injury, poisoning and procedural complications
Laceration
|
0.65%
1/155
|
|
Injury, poisoning and procedural complications
Peripheral Arterial Reocclusion
|
1.3%
2/155
|
|
Injury, poisoning and procedural complications
Peripheral Artery Restenosis
|
5.8%
9/155
|
|
Injury, poisoning and procedural complications
Pneumothorax Traumatic
|
0.65%
1/155
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
0.65%
1/155
|
|
Injury, poisoning and procedural complications
Radial Nerve Injury
|
0.65%
1/155
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.65%
1/155
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.65%
1/155
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.65%
1/155
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
1.9%
3/155
|
|
Injury, poisoning and procedural complications
Wound
|
0.65%
1/155
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.65%
1/155
|
|
Investigations
Haemoglobin Decreased
|
0.65%
1/155
|
|
Investigations
Staphylococcus Test
|
0.65%
1/155
|
|
Metabolism and nutrition disorders
Abnormal Loss Of Weight
|
0.65%
1/155
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.65%
1/155
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.65%
1/155
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.3%
2/155
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.65%
1/155
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.65%
1/155
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/155
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
0.65%
1/155
|
|
Musculoskeletal and connective tissue disorders
Immune-Mediated Necrotising Myopathy
|
0.65%
1/155
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
1.3%
2/155
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
2/155
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
1.3%
2/155
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.65%
1/155
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
1.3%
2/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Of Pleura
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.65%
1/155
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Lung
|
0.65%
1/155
|
|
Nervous system disorders
Carotid Artery Occlusion
|
0.65%
1/155
|
|
Nervous system disorders
Carotid Artery Stenosis
|
4.5%
7/155
|
|
Nervous system disorders
Cerebellar Ischaemia
|
0.65%
1/155
|
|
Nervous system disorders
Cervical Myelopathy
|
0.65%
1/155
|
|
Nervous system disorders
Dizziness
|
0.65%
1/155
|
|
Nervous system disorders
Presyncope
|
0.65%
1/155
|
|
Nervous system disorders
Radial Nerve Palsy
|
0.65%
1/155
|
|
Nervous system disorders
Sciatica
|
0.65%
1/155
|
|
Nervous system disorders
Syncope
|
0.65%
1/155
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.9%
3/155
|
|
Psychiatric disorders
Psychosomatic Disease
|
0.65%
1/155
|
|
Renal and urinary disorders
Bladder Mass
|
1.3%
2/155
|
|
Renal and urinary disorders
Calculus Urinary
|
0.65%
1/155
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.3%
2/155
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.65%
1/155
|
|
Renal and urinary disorders
Renal Failure
|
0.65%
1/155
|
|
Renal and urinary disorders
Renal Failure Acute
|
3.2%
5/155
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.65%
1/155
|
|
Renal and urinary disorders
Urinary Retention
|
1.9%
3/155
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.65%
1/155
|
|
Reproductive system and breast disorders
Genital Prolapse
|
0.65%
1/155
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.65%
1/155
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.9%
3/155
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
1/155
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.65%
1/155
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.65%
1/155
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.65%
1/155
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.65%
1/155
|
|
Surgical and medical procedures
Incisional Drainage
|
0.65%
1/155
|
|
Vascular disorders
Arteriovenous Fistula
|
0.65%
1/155
|
|
Vascular disorders
Diabetic Microangiopathy
|
0.65%
1/155
|
|
Vascular disorders
Hypertensive Crisis
|
0.65%
1/155
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.65%
1/155
|
|
Vascular disorders
Intermittent Claudication
|
0.65%
1/155
|
|
Vascular disorders
Leriche Syndrome
|
0.65%
1/155
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
9.0%
14/155
|
|
Vascular disorders
Peripheral Artery Dissection
|
0.65%
1/155
|
|
Vascular disorders
Peripheral Artery Stenosis
|
12.3%
19/155
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
1.3%
2/155
|
|
Vascular disorders
Peripheral Embolism
|
0.65%
1/155
|
|
Vascular disorders
Peripheral Ischaemia
|
1.3%
2/155
|
|
Vascular disorders
Subclavian Artery Occlusion
|
0.65%
1/155
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.65%
1/155
|
|
Vascular disorders
Venous Insufficiency
|
0.65%
1/155
|
Other adverse events
| Measure |
LIFESTREAM™
n=155 participants at risk
This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
5.2%
8/155
|
|
General disorders
Adverse Drug Reaction
|
5.8%
9/155
|
|
General disorders
Device Occlusion
|
5.2%
8/155
|
|
General disorders
Oedema Peripheral
|
5.2%
8/155
|
|
General disorders
Vessel Puncture Site Haematoma
|
5.8%
9/155
|
|
Injury, poisoning and procedural complications
Peripheral Artery Restenosis
|
11.0%
17/155
|
|
Nervous system disorders
Carotid Artery Stenosis
|
7.1%
11/155
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.8%
9/155
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
12.3%
19/155
|
|
Vascular disorders
Peripheral Artery Dissection
|
5.8%
9/155
|
|
Vascular disorders
Peripheral Artery Stenosis
|
25.2%
39/155
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to PI publication of site results, sponsor requires publication of multi-centers results.
- Publication restrictions are in place
Restriction type: OTHER