Peripheral Artery Disease, Peripheral Vascular Disease, Arterial Occlusive Disease
Conditions
Keywords
Lack of perfusion in the extremities, Atherosclerosis, Intermittent claudication, BOLSTER
Brief summary
Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.
Interventions
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.
DEVICELIFESTREAM™ covered stent
Implantation of the LIFESTREAM™ covered stent
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
CLINICAL INCLUSION CRITERIA: * The subject provides written informed consent using an Informed Consent Form approved by the Ethics Committee/ Institutional Review Board for the site. * Subject agrees to comply with the protocol-mandated follow-up procedures and visits. * Subject is a male or non-pregnant female ≥ 21 years old with an expected lifespan sufficient to allow for completion of all study procedures. * Subject has intermittent claudication (Rutherford Category 2-3) or ischemic rest pain (Rutherford Category 4). * Subject is able and willing to comply with any required medication regimen. ANGIOGRAPHIC INCLUSION CRITERIA: * Subject has evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion in the native common and/or external iliac artery that is ≥ 50% stenosed (including total occlusions). * The target lesion can be successfully crossed with a guide wire and pre-dilated with an appropriately sized PTA balloon. * The reference vessel diameter is between 4.5 mm -12.0 mm in diameter. * The target lesion is ≤ 100 mm in combined length (per side). * The subject has angiographic evidence of a patent (\< 50% stenosis) profunda and/or superficial femoral artery (SFA) in the target limb. CLINICAL
Exclusion criteria
* The subject is unable or unwilling to provide written informed consent or to conform to the study protocol follow-up procedures and visits. * The subject is or plans to become pregnant during the study. * The subject is asymptomatic, has mild claudication or critical limb ischemia with tissue loss described as Rutherford Category 0, 1, 5 or 6. * The subject has a vascular graft previously implanted in the native iliac vessel. * The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA) within 3 months prior to the index procedure. * The subject has a known uncorrectable bleeding diathesis or active coagulopathy. * The subject has a serum creatinine ≥ 2.5 mg/dl or is on dialysis. * The subject has a known allergy or sensitivity to stainless steel (i.e., Nickel), ePTFE, or has intolerance to the antiplatelet, anticoagulant or thrombolytic medications required per the protocol. * The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated. * The subject had a prior vascular intervention within 30 days before or planned for within 30 days after the index procedure. * The subject has another medical condition, which may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up. * The subject is currently participating in an investigational drug, biologic, or another device study. ANGIOGRAPHIC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 9 months post index procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure. | 9 months post index procedure | 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. |
| Number of Lesions With Acute Lesion Success | At time of Index Procedure | Acute 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. |
| Number of Participants With Acute Procedure Success | At time of hospital discharge | 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. |
| Number of Devices With Acute Technical Success at Index Procedure | At time of index procedure | Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator. |
| Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure | 6, 9, 12, 24, and 36 months post index procedure | 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. |
| Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure. | 6, 9, 12, 24, and 36 months post index procedure | 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. |
| Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure | 30 days, and 9, 12, 24, and 36 months post index procedure | 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. |
| Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure | 9, 12, 24 and 36 months post index procedure | Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR ≤ 2.4. |
| Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure | 9, 12, 24, and 36 months post index procedure | 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. |
| Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure. | 9,12, 24, and 36 months post index procedure | 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. |
| Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline. | 30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline. | 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. |
Countries
Germany, New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 155 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 11 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Other | 6 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | LIFESTREAM™ |
|---|---|
| Age, Continuous | 64.3 Years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Germany | 77 participants |
| Region of Enrollment New Zealand | 21 participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 155 |
| other Total, other adverse events | 134 / 155 |
| serious Total, serious adverse events | 60 / 155 |
Outcome results
Primary
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.
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.
Time frame: 9 months post index procedure
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LIFESTREAM™ | 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 |
Comparison: H0: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is greater than or equal to that of the PG of 19.5%.~H1: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is less than that of the PG of 19.5%.p-value: <0.0325Exact binomial test
Secondary
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
Secondary
Number of Devices With Acute Technical Success at Index Procedure
Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator.
Time frame: At time of index procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| LIFESTREAM™ | Number of Devices With Acute Technical Success at Index Procedure | 226 Devices |
Secondary
Number of Lesions With Acute Lesion Success
Acute 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.
Time frame: At time of Index Procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| LIFESTREAM™ | Number of Lesions With Acute Lesion Success | 188 Lesions |
Secondary
Number of Participants With Acute Procedure Success
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.
Time frame: At time of hospital discharge
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. In this instance, three subjects did not have procedure angiography data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LIFESTREAM™ | Number of Participants With Acute Procedure Success | 148 Participants |
Secondary
Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
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.
Time frame: 9, 12, 24, and 36 months post index procedure
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LIFESTREAM™ | Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure | 9 months post index procedure | 119 Participants |
| LIFESTREAM™ | Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure | 12 months post index procedure | 112 Participants |
| LIFESTREAM™ | Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure | 24 months post index procedure | 98 Participants |
| LIFESTREAM™ | 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
Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.
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.
Time frame: 9 months post index procedure
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LIFESTREAM™ | Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure. | 7 Participants |
Secondary
Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR ≤ 2.4.
Time frame: 9, 12, 24 and 36 months post index procedure
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LIFESTREAM™ | Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure | 9 months post index procedure | 118 Participants |
| LIFESTREAM™ | Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure | 12 months post index procedure | 110 Participants |
| LIFESTREAM™ | Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure | 24 months post index procedure | 92 Participants |
| LIFESTREAM™ | Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure | 36 months post index procedure | 72 Participants |
Secondary
Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.
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.
Time frame: 9,12, 24, and 36 months post index procedure
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LIFESTREAM™ | Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure. | 9 months post index procedure | 121 Participants |
| LIFESTREAM™ | Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure. | 12 months post index procedure | 112 Participants |
| LIFESTREAM™ | Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure. | 24 months post index procedure | 100 Participants |
| LIFESTREAM™ | Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure. | 36 months post index procedure | 79 Participants |
Secondary
Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
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.
Time frame: 30 days, and 9, 12, 24, and 36 months post index procedure
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
Secondary
Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
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.
Time frame: 6, 9, 12, 24, and 36 months post index procedure
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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
Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
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.
Time frame: 6, 9, 12, 24, and 36 months post index procedure
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |
| LIFESTREAM™ | 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 |