Trial Outcomes & Findings for CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM") (NCT NCT00908947)
NCT ID: NCT00908947
Last Updated: 2019-11-19
Results Overview
Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
173 participants
Primary outcome timeframe
30-days and 12-months
Results posted on
2019-11-19
Participant Flow
First subject enrolled on February 9, 2011 and the final follow-up was completed on September 19, 2018.
Participant milestones
| Measure |
LifeStent
Percutaneous Transluminal Angioplasty (PTA) followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Overall Study
STARTED
|
173
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
90
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
data was collected for 171 out of 173 patients, thus, 2 patients did not have Rutherford category assigned at baseline.
Baseline characteristics by cohort
| Measure |
LifeStent
n=173 Participants
Percutaneous trasluminal angioplasty (PTA) plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Age, Continuous
|
70.2 Years
STANDARD_DEVIATION 9.87 • n=173 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=173 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=173 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=173 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
158 Participants
n=173 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=173 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=173 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=173 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=173 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=173 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=173 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=173 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=173 Participants
|
|
Region of Enrollment
United States
|
173 participants
n=173 Participants
|
|
Rutherford Category
0: Asymptomatic
|
0 Participants
n=171 Participants • data was collected for 171 out of 173 patients, thus, 2 patients did not have Rutherford category assigned at baseline.
|
|
Rutherford Category
1: Mild Claudication
|
0 Participants
n=171 Participants • data was collected for 171 out of 173 patients, thus, 2 patients did not have Rutherford category assigned at baseline.
|
|
Rutherford Category
2: Moderate Claudication
|
25 Participants
n=171 Participants • data was collected for 171 out of 173 patients, thus, 2 patients did not have Rutherford category assigned at baseline.
|
|
Rutherford Category
3: Severe Claudication
|
114 Participants
n=171 Participants • data was collected for 171 out of 173 patients, thus, 2 patients did not have Rutherford category assigned at baseline.
|
|
Rutherford Category
4: Ischemic Rest Pain
|
31 Participants
n=171 Participants • data was collected for 171 out of 173 patients, thus, 2 patients did not have Rutherford category assigned at baseline.
|
|
Rutherford Category
5: Minor Tissue Loss
|
0 Participants
n=171 Participants • data was collected for 171 out of 173 patients, thus, 2 patients did not have Rutherford category assigned at baseline.
|
|
Rutherford Category
6: Major Tissue Loss
|
1 Participants
n=171 Participants • data was collected for 171 out of 173 patients, thus, 2 patients did not have Rutherford category assigned at baseline.
|
|
Number of Target Lesions per Subject
1
|
161 Participants
n=173 Participants
|
|
Number of Target Lesions per Subject
2
|
10 Participants
n=173 Participants
|
|
Number of Target Lesions per Subject
3
|
2 Participants
n=173 Participants
|
|
Target Limb
Left
|
91 Participants
n=173 Participants
|
|
Target Limb
Right
|
82 Participants
n=173 Participants
|
|
Lesion Type
Stenosed
|
124 Lesion type
n=173 Participants
|
|
Lesion Type
Occlusion
|
57 Lesion type
n=173 Participants
|
|
Lesion Type
Restenosed
|
6 Lesion type
n=173 Participants
|
|
Lesion Location
Proximal 1/3 of Superficial femoral Artery (SFA)
|
32 Lesions
n=173 Participants
|
|
Lesion Location
Distal 1/3 of Superficial femoral artery (SFA)
|
80 Lesions
n=173 Participants
|
|
Lesion Location
Mid 1/3 of Superficial femoral artery (SFA)
|
69 Lesions
n=173 Participants
|
|
Lesion Location
Unknown
|
6 Lesions
n=173 Participants
|
|
Lesion Calcification
Absent
|
25 Lesions
n=173 Participants
|
|
Lesion Calcification
Mild
|
54 Lesions
n=173 Participants
|
|
Lesion Calcification
Moderate
|
68 Lesions
n=173 Participants
|
|
Lesion Calcification
Severe
|
40 Lesions
n=173 Participants
|
|
Lesion Calcification
Lesion Ulceration
|
24 Lesions
n=173 Participants
|
|
Lesion Calcification
Lesion Thrombus
|
5 Lesions
n=173 Participants
|
PRIMARY outcome
Timeframe: 30-days and 12-monthsPopulation: One subject expired on day 22 post-index procedure due to pneumonia (total N = 173, as per Participant Flow). The event was unrelated to study device but possibly related to procedure as adjudicated by the Clinical Events Committee (CEC).
Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure.
Outcome measures
| Measure |
Overall Study
n=172 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure.
30-days Post Index Procedure
|
0.994 Probability of Event Free
Interval 0.959 to 0.999
|
|
Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure.
12-Months Post Index Procedure
|
0.951 Probability of Event Free
Interval 0.904 to 0.975
|
PRIMARY outcome
Timeframe: At time of procedure (acute) and 12-months post-index procedure (Chronic)The primary effectiveness endpoint of the study, device success, collectively measured both acute and chronic effectiveness. Acute effectiveness is defined as successful delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length. Chronic effectiveness is defined as Primary Target Lesion Patency (TLP) at 12-months post-index procedure, as measured by Duplex Ultrasound (DUS).
Outcome measures
| Measure |
Overall Study
n=173 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure
Acute effectiveness
|
0.990 Probability of effectiveness
Interval 0.948 to 1.0
|
|
Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure
Device success at 12-month
|
0.727 Probability of effectiveness
Interval 0.618 to 0.81
|
SECONDARY outcome
Timeframe: 12-months post-index procedureTarget Lesion Revascularization (TLR) is defined as the interval following the index procedure until the first revascularization procedure of the target lesion. Target Vessel Revascularization (TVR) is defined as the interval following the index procedure until the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel.
Outcome measures
| Measure |
Overall Study
n=173 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure.
|
0.822 Probability of Event Free
Interval 0.752 to 0.873
|
SECONDARY outcome
Timeframe: 30-days and 12-months Post -Index ProcedurePopulation: Target lesions \>160mm = 18 participants, and Target lesions treated with 200mm LifeStent = 41 participants. Therefore N=59.
• Primary Safety (freedom from occurrence of death at 30-days and 12-months post-index procedure) of the Target Lesion Lengths \> 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.
Outcome measures
| Measure |
Overall Study
n=59 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm.
Target Lesion Length > 160 at 30-days
|
1 Probability of Event Free
Interval 1.0 to 1.0
|
|
Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm.
Target Lesion Length > 160 at 12-months
|
0.871 Probability of Event Free
Interval 0.641 to 0.958
|
|
Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm.
Target Lesion Length 200 mm at 30-days
|
1.000 Probability of Event Free
Interval 1.0 to 1.0
|
|
Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm.
Target Lesion Length 200 mm at 12-months
|
0.976 Probability of Event Free
Interval 0.88 to 0.995
|
SECONDARY outcome
Timeframe: 12-months Post-Index ProcedurePopulation: Target lesions \>160mm = 18 participants, and Target lesions treated with 200mm LifeStent = 41 participants. Therefore N=59.
Primary Effectiveness (Device Success) of Target Lesion Lengths \> 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.
Outcome measures
| Measure |
Overall Study
n=59 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm.
Target Lesion Length > 160 at 12 months
|
0.438 Probability Device Success
Interval 0.143 to 0.704
|
|
Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm.
Target Lesion Length LifeStent 200 mm at 12 months
|
0.600 Probability Device Success
Interval 0.399 to 0.753
|
SECONDARY outcome
Timeframe: 12- and 24-months post-index procedurePopulation: The results presented in this analysis include active patients that had available x-ray images appropriate for analysis by the core-lab at follow-up time (12 and 24 months). Therefore n=166 instead of N=173.
Freedom from Fracture (FFF) at 12- and 24-months post-index procedure.
Outcome measures
| Measure |
Overall Study
n=166 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Freedom From Fracture at 12 and 24-Months Post-Index Procedure
12-Months Post-Index Procedure
|
0.928 Probability of Event Free
Interval 0.878 to 0.958
|
|
Freedom From Fracture at 12 and 24-Months Post-Index Procedure
24-Months Post-Index Procedure
|
0.699 Probability of Event Free
Interval 0.619 to 0.765
|
SECONDARY outcome
Timeframe: 12, 24, and 36 months Post Index ProcedurePopulation: Eighteen (18) patients were enrolled with lesions \>160mm, therefore N=18. However, 15 patients had available data for analysis at 12, 24 and 36 months, therefore n=15.
Primary Target Lesion Patency (TLP) - Sustained and Expanded - for Target Lesion Lengths \> 160 mm at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Ratio (PSR) values of \< 2.0, \<2.5, and \< 3.0.
Outcome measures
| Measure |
Overall Study
n=18 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
At 24-months (PSR < 3.0
|
0.232 Probability of Event Free
Interval 0.076 to 0.438
|
|
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
At 36-months (PSR < 3.0)
|
0.232 Probability of Event Free
Interval 0.076 to 0.438
|
|
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
At 12-months (PSR < 2.0)
|
0.464 Probability of Event Free
Interval 0.234 to 0.667
|
|
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
At 24-months (PSR < 2.0)
|
0.155 Probability of Event Free
Interval 0.037 to 0.349
|
|
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
At 36-months (PSR < 2.0)
|
0.155 Probability of Event Free
Interval 0.037 to 0.349
|
|
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
At 12-months (PSR < 2.5)
|
0.464 Probability of Event Free
Interval 0.234 to 0.667
|
|
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
At 24-months (PSR < 2.5)
|
0.232 Probability of Event Free
Interval 0.076 to 0.438
|
|
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
At 36-months (PSR < 2.5)
|
0.232 Probability of Event Free
Interval 0.076 to 0.438
|
|
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
At 12-months (PSR < 3.0)
|
0.464 Probability of Event Free
Interval 0.234 to 0.667
|
SECONDARY outcome
Timeframe: 12-, 24-, and 36-months post-index procedureFreedom from Target Lesion Revascularization (TTR) and/or Target Vessel Revascularization (TRV) for Target Lesion Lengths \> 160 mm at 12-, 24- and 36-months post-index procedure.
Outcome measures
| Measure |
Overall Study
n=173 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm.
12-months post-index procedure
|
0.696 Probability of Event Free
Interval 0.436 to 0.854
|
|
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm.
24-months post-index procedure
|
0.696 Probability of Event Free
Interval 0.436 to 0.854
|
|
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm.
36-months post index procedure
|
0.696 Probability of Event Free
Interval 0.436 to 0.854
|
SECONDARY outcome
Timeframe: 30-days and 12-, 24-, and 36-months post-index procedurePopulation: (n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section
Secondary Safety (Freedom from Composite Adverse Events) is defined as freedom from death (excluding 30-days and 12-months post-index procedure), stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 30-days and 12-, 24-, and 36-months post-index procedure.
Outcome measures
| Measure |
Overall Study
n=173 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Secondary Safety Endpoint: Freedom From Composite Adverse Events
30-days Post Index Procedure
|
0.994 Probability of Event Free
Interval 0.97 to 0.999
|
|
Secondary Safety Endpoint: Freedom From Composite Adverse Events
12-Months Post Index Procedure
|
0.988 Probability of Event Free
Interval 0.961 to 0.996
|
|
Secondary Safety Endpoint: Freedom From Composite Adverse Events
24-Months Post-Index Procedure
|
0.945 Probability of Event Free
Interval 0.904 to 0.969
|
|
Secondary Safety Endpoint: Freedom From Composite Adverse Events
36-Months Post-Index Procedure
|
0.901 Probability of Event Free
Interval 0.847 to 0.936
|
SECONDARY outcome
Timeframe: Intra-procedureAcute technical success is defined as successful deployment of the stent to the intended location.
Outcome measures
| Measure |
Overall Study
n=217 Stents
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Number of Stents Deployed With Acute Technical Success
|
201 Stents
|
SECONDARY outcome
Timeframe: Intra-procedurePopulation: N=175 (lesions) differs from the baseline characteristics module that mentions 187 treated lesions due to availability of angiographic image that show less than, or equal to 30% residual stenosis post-dilatation, as evaluated by the independent core-lab at time of analysis.
Acute lesion success is defined as attainment of ≤ 30% residual stenosis of the target lesion using any percutaneous method and/or non-investigational device (i.e., post-dilatation) based on angiographic data.
Outcome measures
| Measure |
Overall Study
n=175 Target lesions
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Number of Acute Lesion Success
|
152 Target lesions
|
SECONDARY outcome
Timeframe: Intra-procedurePopulation: One patient died at day 22, therefore, in this analysis N=172 instead of N=173.
Acute procedure success is defined as lesion success and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel).
Outcome measures
| Measure |
Overall Study
n=172 Procedures
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Number of Procedures With Acute Success
|
149 Procedures
|
SECONDARY outcome
Timeframe: 24- and 36-months post-index procedureSustained Freedom from Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24- and 36-months post-index procedure.
Outcome measures
| Measure |
Overall Study
n=173 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure
36-Months Post-Index Procedure (PSR < 2.5)
|
0.631 Probability of Freedom from TLR or TRV
Interval 0.56 to 0.695
|
|
Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure
24-Months Post-Index Procedure
|
0.669 Probability of Freedom from TLR or TRV
Interval 0.6 to 0.729
|
SECONDARY outcome
Timeframe: 30 days, 12-, 24-, and 36-months post-index procedurePopulation: The number of participants for each time period represents the evaluable subjects for this specific outcome measure.
Sustained hemodynamic success is defined as sustained improvement of Ankle-Brachial Index (ABI) from baseline value of ≥ 0.15 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated Target Lesion Revascularization (TLR) in surviving subjects.
Outcome measures
| Measure |
Overall Study
n=99 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure
30-Days Post Index Procedure
|
64 Participants
|
|
Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure
12-Months Post-Index Procedure
|
32 Participants
|
|
Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure
24-Months Post-Index Procedure
|
17 Participants
|
|
Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure
36-Months Post-Index Procedure
|
13 Participants
|
SECONDARY outcome
Timeframe: 30-days and 12-, 24-, and 36-months post-index procedurePopulation: (n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section
Sustained clinical success is defined as sustained cumulative improvement from baseline value of ≥ 1 category according to Rutherford et al.12 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated TLR in surviving subjects.
Outcome measures
| Measure |
Overall Study
n=157 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure
30-days Post Index Procedure
|
142 Participants
|
|
Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure
12-Months Post Index Procedure
|
91 Participants
|
|
Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure
24-Months Post-Index Procedure
|
56 Participants
|
|
Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure
36-Months Post-Index Procedure
|
33 Participants
|
SECONDARY outcome
Timeframe: 24- and 36-months post-index procedurePopulation: The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (24 and 36 months). Therefore n=161 instead of N=173.
Sustained Target Lesion Patency (TLP) was measured at 24- and 36-months post-index procedure corresponding to PSR \< 2.5.
Outcome measures
| Measure |
Overall Study
n=161 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure
24-Months Post-Index Procedure (PSR < 2.5)
|
0.510 Probability of sustained lesion patency
Interval 0.436 to 0.578
|
|
Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure
36-Months Post-Index Procedure (PSR < 2.5)
|
0.457 Probability of sustained lesion patency
Interval 0.382 to 0.529
|
SECONDARY outcome
Timeframe: 12, 24, and 36 months Post-Index ProcedurePopulation: The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (12, 24 and 36 months). Therefore n=161 instead of N=173.
Expanded TLP was measured at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) \< 3.0.
Outcome measures
| Measure |
Overall Study
n=161 Lesion
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure
At 12-months (PSR < 3.0)
|
0.761 Probability of Lesion Patency
Interval 0.696 to 0.814
|
|
Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure
At 24-months (PSR < 3.0)
|
0.523 Probability of Lesion Patency
Interval 0.45 to 0.591
|
|
Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure
At 36-months (PSR < 3.0)
|
0.470 Probability of Lesion Patency
Interval 0.394 to 0.542
|
SECONDARY outcome
Timeframe: 12, 24, and 36 Months Post-Index ProcedurePopulation: The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (12, 24 and 36 months). Therefore n=160 instead of N=173.
Cumulative (primary-assisted and secondary) Target Lesion Patency (TLP) was measured at 12-, 24-, and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) \< 2.5, and PSR \< 3.0.
Outcome measures
| Measure |
Overall Study
n=160 Lesions
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
At 36-months (PSR < 3.0)
|
0.745 Probability of Target Lesion Patency
Interval 0.673 to 0.803
|
|
Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
At 12-months (PSR < 2.5)
|
0.920 Probability of Target Lesion Patency
Interval 0.873 to 0.951
|
|
Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
At 24-months (PSR < 2.5)
|
0.745 Probability of Target Lesion Patency
Interval 0.675 to 0.802
|
|
Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
At 36-months (PSR < 2.5)
|
0.717 Probability of Target Lesion Patency
Interval 0.644 to 0.777
|
|
Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
At 12-months (PSR < 3.0)
|
0.928 Probability of Target Lesion Patency
Interval 0.882 to 0.956
|
|
Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
At 24-months (PSR < 3.0)
|
0.784 Probability of Target Lesion Patency
Interval 0.717 to 0.837
|
SECONDARY outcome
Timeframe: 30-days, and 12-, 24-, and 36-months post-index procedurePopulation: (n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.
The Walking Impairment Questionnaire (WIQ) evaluation scale values range from 0 to 100, with 0 meaning inability to complete the specific task and 100 representing no difficulty in completing the task. A higher score (mean) represents an improvement in walking abilities compared to baseline measure. The results below represent, for each item measured (pain, walking distance, walking speed, and stair climbing), the mean difference between the score observed at Baseline and those observed at 30-days, 12-, 24-, and 36-months post-index procedure.
Outcome measures
| Measure |
Overall Study
n=159 Participants
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Walking Distance at 30-days Post-Index Procedure
|
26.46 Score on a Scale
Standard Deviation 33.55
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Walking Distance at 12-Months Post-Index Procedure
|
19.89 Score on a Scale
Standard Deviation 35.83
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Pain at 36-Months Post-Index Procedure
|
30.7 Score on a Scale
Standard Deviation 40.24
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Walking Distance at 24-Months Post-Index Procedure
|
22.97 Score on a Scale
Standard Deviation 30.83
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Walking Distance at 36-Months Post-Index Procedure
|
26.39 Score on a Scale
Standard Deviation 35.99
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Walking Speed at 30-days Post-Index Procedure
|
18.09 Score on a Scale
Standard Deviation 24.51
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Walking Speed at 12-Months Post-Index Procedure
|
13.39 Score on a Scale
Standard Deviation 27.23
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Walking Speed at 24-Months Post-Index Procedure
|
14.64 Score on a Scale
Standard Deviation 23.37
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Walking Speed at 36-Months Post-Index Procedure
|
13.19 Score on a Scale
Standard Deviation 27.33
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Stair Climbing at 30-days Post-Index Procedure
|
22.19 Score on a Scale
Standard Deviation 34.37
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Stair Climbing at 12-Months Post-Index Procedure
|
16.96 Score on a Scale
Standard Deviation 34.80
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Stair Climbing at 24-Months Post-Index Procedure
|
16.96 Score on a Scale
Standard Deviation 34.81
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Stair Climbing at 36-Months Post-Index Procedure
|
10.05 Score on a Scale
Standard Deviation 38.47
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Pain at 30-days Post-Index Procedure
|
43.4 Score on a Scale
Standard Deviation 34.61
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Pain at 12-Months Post-Index Procedure
|
30.8 Score on a Scale
Standard Deviation 39.59
|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
Pain at 24-Months Post-Index Procedure
|
33.8 Score on a Scale
Standard Deviation 42.46
|
Adverse Events
LifeStent
Serious events: 111 serious events
Other events: 150 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
LifeStent
n=173 participants at risk
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
6/173 • Number of events 6 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Acute myocardial infarction
|
3.5%
6/173 • Number of events 6 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Angina pectoris
|
4.0%
7/173 • Number of events 7 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Angina unstable
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Bradycardia
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Cardiac arrest
|
2.3%
4/173 • Number of events 4 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Cardiac failure acute
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Cardiac failure congestive
|
6.4%
11/173 • Number of events 11 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Cardiomyopathy
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Chest pain
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Coronary artery disease
|
5.2%
9/173 • Number of events 9 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Coronary artery stenosis
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Pericardial effusion
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Tachycardia
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Eye disorders
Amaurosis fugax
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Eye disorders
Cataract
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Eye disorders
Eye disorder
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Eye disorders
Macular degeneration
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Gastritis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.6%
8/173 • Number of events 8 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Haematemesis
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Adverse drug reaction
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Chest pain
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Device breakage
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Device dislocation
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Device occlusion
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Granuloma
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Ischaemic ulcer
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Medical device complication
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Non-cardiac chest pain
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Ulcer
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Abdominal wall abscess
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Cellulitis
|
4.0%
7/173 • Number of events 7 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Clostridial infection
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Diabetic foot infection
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Diverticulitis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Endocarditis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Furuncle
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Gastroenteritis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Helicobacter gastritis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Localised infection
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Osteomyelitis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Pneumonia
|
3.5%
6/173 • Number of events 6 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Postoperative wound infection
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Pyelonephritis acute
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Sepsis
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Septic shock
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Serratia infection
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Tooth abscess
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Urinary tract infection
|
4.0%
7/173 • Number of events 7 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Viral pericarditis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
2.3%
4/173 • Number of events 4 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Investigations
Positron emission tomogram abnormal
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Duodenal neoplasm
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Carotid artery stenosis
|
2.3%
4/173 • Number of events 4 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Cerebral infarction
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Cerebrovascular accident
|
2.9%
5/173 • Number of events 5 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Convulsion
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Dementia
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Neuromyopathy
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Syncope
|
2.3%
4/173 • Number of events 4 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Transient ischaemic attack
|
2.3%
4/173 • Number of events 4 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Renal and urinary disorders
Renal failure
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Renal and urinary disorders
Renal failure chronic
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
4/173 • Number of events 4 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.7%
3/173 • Number of events 3 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Surgical and medical procedures
Angioplasty
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Surgical and medical procedures
Carotid endarterectomy
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Surgical and medical procedures
Gastric tube reconstruction
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Surgical and medical procedures
Peripheral revascularisation
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Surgical and medical procedures
Polypectomy
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Surgical and medical procedures
Vascular operation
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Aortic aneurysm
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Aortic stenosis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Arterial stenosis limb
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Arteriosclerosis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Carotid artery stenosis
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Deep vein thrombosis
|
3.5%
6/173 • Number of events 6 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Femoral arterial stenosis
|
2.9%
5/173 • Number of events 5 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Femoral artery occlusion
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Haematoma
|
1.2%
2/173 • Number of events 2 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Hypotension
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Intermittent claudication
|
9.2%
16/173 • Number of events 16 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Ischaemia
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Lymphoedema
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
5.2%
9/173 • Number of events 9 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Peripheral ischaemia
|
2.3%
4/173 • Number of events 4 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Peripheral vascular disorder
|
9.2%
16/173 • Number of events 16 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Venous insufficiency
|
0.58%
1/173 • Number of events 1 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
Other adverse events
| Measure |
LifeStent
n=173 participants at risk
PTA plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.6%
20/173 • Number of events 20 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Angina pectoris
|
6.4%
11/173 • Number of events 11 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Cardiac failure congestive
|
8.1%
14/173 • Number of events 14 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Cardiac disorders
Coronary artery disease
|
5.8%
10/173 • Number of events 10 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Device breakage
|
6.9%
12/173 • Number of events 12 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
General disorders
Oedema peripheral
|
6.9%
12/173 • Number of events 12 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Cellulitis
|
8.1%
14/173 • Number of events 14 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Pneumonia
|
6.4%
11/173 • Number of events 11 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Infections and infestations
Urinary tract infection
|
9.8%
17/173 • Number of events 17 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
9/173 • Number of events 9 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.3%
23/173 • Number of events 23 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Nervous system disorders
Neuropathy peripheral
|
5.2%
9/173 • Number of events 9 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Renal and urinary disorders
Renal failure acute
|
9.8%
17/173 • Number of events 17 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.2%
9/173 • Number of events 9 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.9%
12/173 • Number of events 12 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Femoral artery stenosis
|
5.8%
10/173 • Number of events 10 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Haematoma
|
8.1%
14/173 • Number of events 14 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Intermittent claudication
|
14.5%
25/173 • Number of events 25 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
8.7%
15/173 • Number of events 15 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
|
Vascular disorders
Peripheral vascular disorder
|
11.6%
20/173 • Number of events 20 • Adverse events were collected from enrollment until final patient follow up visit (36-months follow up or end of study visit).
|
Additional Information
Talar Saber, Senior Project Manager, Clinical Affairs
BD/Bard
Phone: 1.480.379.2839
Email: [email protected]
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