Peripheral Arterial Disease
Conditions
Keywords
Peripheral Arterial Disease, Drug coated balloon, Superficial Femoral Artery, Popliteal Femoral Artery, Atherosclerosis, Drug eluting balloon
Brief summary
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a real world patient population.
Detailed description
Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death. The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.
Interventions
DEVICEIN.PACT Admiral™ Drug Eluting Balloon
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General inclusion Criteria: * Age ≥ 18 years or minimum age as required by local regulations. * Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4. * Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days. General
Exclusion criteria
* High probability of non-adherence to Clinical Investigation Protocol follow-up requirements. * Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations). * Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cohort ITT - Primary Effectiveness Endpoint | 12 months | Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI. |
| Clinical Cohort ITT - Primary Safety Endpoint | 12 months | A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure. |
| Imaging Cohort ITT - Primary Effectiveness Endpoint | 12 months | Primary Patency within 12 months post-index procedure, which is defined as: * Freedom from clinically-driven TLR and * Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. * Restenosis determined by either PSVR \>2.4 as assessed by an independent DUS core lab or \>50% stenosis as assessed by an independent angiographic core lab. |
| 150mm DEB ITT Cohort - Primary Effectiveness Endpoint | 12 months | Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cohort ITT - Clinical Success | prior to discharge | Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge |
| Clinical Cohort ITT - Clinically-driven TLR | 60 months | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI. |
| Clinical Cohort ITT - Time to First Clinically-driven TLR (Days) | 60 months | — |
| Clinical Cohort ITT - Procedural Success | at procedure | Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate |
| Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure. | 60 months | All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months |
| Clinical Cohort ITT - Primary Sustained Clinical Improvement | 6 Months | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects |
| Clinical Cohort ITT - Secondary Sustained Clinical Improvement | 6 Months | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. |
| Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure | Post procedure | Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9 |
| Clinical Cohort ITT - Sustained Hemodynamic Improvement | 6 Months | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. |
| Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 6 Months | — |
| Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) | 6 Months | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. |
| 150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days) | 60 months | — |
| Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion | at 12 months, or at the time of re-intervention | — |
| Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion | At 12 months, or at the time of re-intervention | — |
| 150mm DEB ITT Cohort - MAEs | 30 days | Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days. |
| 150mm DEB ITT Cohort - Clinically-driven TLR | 30 days | Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI. |
| 150mm DEB ITT Cohort - TLR | 6 Months | Any Target lesion revascularisation |
| 150mm DEB ITT Cohort - TVR | 6 Months | Any Target lesion revascularisation |
| 150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure. | 60 months | All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months |
| 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement | 6 months. | Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. |
| 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement | 6 Months | Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. |
| 150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure | Post procedure | Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9 |
| 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement | 6 Months | Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects. |
| 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 6 Months | — |
| 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) | 6 Months | The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better. |
| 150mm DEB ITT Cohort - Device Success | Index-procedure | Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP) |
| 150mm DEB ITT Cohort - Procedural Success | at procedure | Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate |
| 150mm DEB ITT Cohort - Clinical Success | prior to discharge | Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge |
| Clinical Cohort ITT - All-cause Mortality | 30 days | — |
| Clinical Cohort ITT - Clinically-driven TVR | 30 days | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI. |
| Clinical Clinical Cohort ITT - Clinically-driven TVR | 24 Months | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI. |
| Clinical Cohort ITT - Major Target Limb Amputation | 30 days | — |
| 150mm DEB ITT Cohort - All-cause Mortality | 30 days | — |
| Clinical Cohort ITT - MAEs | 12 months | MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site. |
| 150mm DEB ITT Cohort - Major Target Limb Amputation | 30 days | — |
| 150mm DEB ITT Cohort - Clinically-driven TVR | 30 days | Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI. |
| Clinical Cohort ITT - TLR | 12 months | Any Target lesion revascularisation |
| Clinical Cohort ITT - TVR | 12 months. | Any Target vessel revascularisation |
| Clinical Cohort ITT - Device Success | Index-procedure | Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP) |
Countries
Argentina, Australia, Austria, Belgium, Canada, Colombia, Czechia, Egypt, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinical Cohort ITT | 1,406 |
| Total | 1,406 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 253 |
| Overall Study | Exit reason other than withdrawal, death or lost to follow up | 35 |
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | missed visit but known to be alive | 28 |
| Overall Study | Withdrawal by Subject | 151 |
Baseline characteristics
| Characteristic | Clinical Cohort ITT |
|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 453 Participants |
| Sex: Female, Male Male | 953 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 253 / 1,406 |
| other Total, other adverse events | 287 / 1,406 |
| serious Total, serious adverse events | 1,074 / 1,406 |
Outcome results
Primary
150mm DEB ITT Cohort - Primary Effectiveness Endpoint
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Primary Effectiveness Endpoint | 106 Participants |
Primary
Clinical Cohort ITT - Primary Effectiveness Endpoint
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Primary Effectiveness Endpoint | 1263 Participants |
Primary
Clinical Cohort ITT - Primary Safety Endpoint
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Primary Safety Endpoint | 1254 Participants |
Primary
Imaging Cohort ITT - Primary Effectiveness Endpoint
Primary Patency within 12 months post-index procedure, which is defined as: * Freedom from clinically-driven TLR and * Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. * Restenosis determined by either PSVR \>2.4 as assessed by an independent DUS core lab or \>50% stenosis as assessed by an independent angiographic core lab.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Imaging Cohort ITT - Primary Effectiveness Endpoint | 217 Participants |
Secondary
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - All-cause Mortality | 6 Participants |
Secondary
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - All-cause Mortality | 13 Participants |
Secondary
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - All-cause Mortality | 20 Participants |
Secondary
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - All-cause Mortality | 18 Participants |
Secondary
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - All-cause Mortality | 0 Participants |
Secondary
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - All-cause Mortality | 1 Participants |
Secondary
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - All-cause Mortality | 2 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TLR | 4 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 60 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TLR | 28 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 48 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TLR | 27 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TLR | 25 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TLR | 16 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TLR | 0 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TVR | 29 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TVR | 30 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TVR | 0 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TVR | 5 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TVR | 7 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TVR | 17 Participants |
Secondary
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinically-driven TVR | 26 Participants |
Secondary
150mm DEB ITT Cohort - Clinical Success
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Time frame: prior to discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Clinical Success | 115 Participants |
Secondary
150mm DEB ITT Cohort - Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Time frame: Index-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Device Success | 231 Admiral™ Drug-Eluting Balloon |
Secondary
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) | 0.8463 score on a scale | Standard Deviation 0.1771 |
Secondary
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 36 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) | 0.8278 score on a scale | Standard Deviation 0.2003 |
Secondary
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) | 0.7858 score on a scale | Standard Deviation 0.2215 |
Secondary
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index) | 0.8257 score on a scale | Standard Deviation 0.1853 |
Secondary
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Time frame: Post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure | 90 Participants |
Secondary
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Major Target Limb Amputation | 0 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Thrombosis at Target Lesion Site | 1 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | MAEs | 6 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Death | 1 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | CD-TVR | 5 Participants |
Secondary
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.
Time frame: 60 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | MAEs | 47 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Death | 20 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | CD-TVR | 30 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Major Target Limb Amputation | 1 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Thrombosis at Target Lesion Site | 3 Participants |
Secondary
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.
Time frame: 48 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | MAEs | 45 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Death | 18 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | CD-TVR | 29 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Major Target Limb Amputation | 1 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Thrombosis at Target Lesion Site | 3 Participants |
Secondary
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.
Time frame: 36 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Major Target Limb Amputation | 1 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | MAEs | 37 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Death | 13 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | CD-TVR | 26 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Thrombosis at Target Lesion Site | 2 Participants |
Secondary
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.
Time frame: 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | MAEs | 22 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Death | 6 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | CD-TVR | 17 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Major Target Limb Amputation | 1 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Thrombosis at Target Lesion Site | 2 Participants |
Secondary
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | MAEs | 9 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Death | 2 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | CD-TVR | 7 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Major Target Limb Amputation | 0 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Thrombosis at Target Lesion Site | 1 Participants |
Secondary
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | MAEs | 0 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Death | 0 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | CD-TVR | 0 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Major Target Limb Amputation | 0 Participants |
| Clinical Cohort ITT | 150mm DEB ITT Cohort - MAEs | Thrombosis at Target Lesion Site | 0 Participants |
Secondary
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Major Target Limb Amputation | 1 Participants |
Secondary
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Major Target Limb Amputation | 0 Participants |
Secondary
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Major Target Limb Amputation | 0 Participants |
Secondary
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Major Target Limb Amputation | 0 Participants |
Secondary
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Major Target Limb Amputation | 1 Participants |
Secondary
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Major Target Limb Amputation | 1 Participants |
Secondary
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Major Target Limb Amputation | 1 Participants |
Secondary
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement | 87 Participants |
Secondary
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement | 68 Participants |
Secondary
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement | 62 Participants |
Secondary
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement | 97 Participants |
Secondary
150mm DEB ITT Cohort - Procedural Success
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Time frame: at procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Procedural Success | 130 lesions |
Secondary
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement | 90 Participants |
Secondary
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement | 101 Participants |
Secondary
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement | 74 Participants |
Secondary
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement | 76 Participants |
Secondary
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement | 72 Participants |
Secondary
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement | 78 Participants |
Secondary
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement | 43 Participants |
Secondary
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement | 52 Participants |
Secondary
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.
All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months
Time frame: 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure. | 81.1 percentage of survival |
Secondary
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)
Time frame: 60 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days) | 622.2 Days | Standard Deviation 352.8 |
Secondary
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)
Time frame: 60 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days) | 622.2 Days | Standard Deviation 352.8 |
Secondary
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TLR | 7 Participants |
Secondary
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TLR | 5 Participants |
Secondary
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TLR | 29 Participants |
Secondary
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TLR | 28 Participants |
Secondary
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TLR | 26 Participants |
Secondary
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TLR | 17 Participants |
Secondary
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TVR | 8 Participants |
Secondary
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TVR | 27 Participants |
Secondary
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TVR | 30 Participants |
Secondary
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TVR | 31 Participants |
Secondary
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TVR | 6 Participants |
Secondary
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - TVR | 18 Participants |
Secondary
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 78.5 percentage of impairment | Standard Deviation 27.4 |
Secondary
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 77.4 percentage of impairment | Standard Deviation 27.8 |
Secondary
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 36 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 78.5 percentage of impairment | Standard Deviation 25.8 |
Secondary
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 85.9 percentage of impairment | Standard Deviation 23.5 |
Secondary
Clinical Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Clinical Cohort ITT - Clinically-driven TVR | 224 Participants |
Secondary
Clinical Cohort ITT - All-cause Mortality
The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow: 1. Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation 2. Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation 3. Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit. 4. The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - All-cause Mortality | 244 Participants |
Secondary
Clinical Cohort ITT - All-cause Mortality
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - All-cause Mortality | 49 Participants |
Secondary
Clinical Cohort ITT - All-cause Mortality
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - All-cause Mortality | 23 Participants |
Secondary
Clinical Cohort ITT - All-cause Mortality
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - All-cause Mortality | 3 Participants |
Secondary
Clinical Cohort ITT - All-cause Mortality
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - All-cause Mortality | 196 Participants |
Secondary
Clinical Cohort ITT - All-cause Mortality
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - All-cause Mortality | 147 Participants |
Secondary
Clinical Cohort ITT - All-cause Mortality
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - All-cause Mortality | 101 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TLR | 288 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 60 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TLR | 366 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TLR | 331 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TLR | 214 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TLR | 51 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TLR | 13 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TVR | 381 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TVR | 13 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TVR | 342 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TVR | 107 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TVR | 298 Participants |
Secondary
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinically-driven TVR | 54 Participants |
Secondary
Clinical Cohort ITT - Clinical Success
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Time frame: prior to discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Clinical Success | 1376 Participants |
Secondary
Clinical Cohort ITT - Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Time frame: Index-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Device Success | 2988 Admiral™ Drug-Eluting Balloon |
Secondary
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) | 0.7744 score on a scale | Standard Deviation 0.2551 |
Secondary
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 36 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) | 0.7629 score on a scale | Standard Deviation 0.2641 |
Secondary
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) | 0.8124 score on a scale | Standard Deviation 0.2323 |
Secondary
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index) | 0.7970 score on a scale | Standard Deviation 0.2413 |
Secondary
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Time frame: Post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure | 1086 Participants |
Secondary
Clinical Cohort ITT - MAEs
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time frame: 60 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | MAEs | 589 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Deaths | 244 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | CD-TVR | 381 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Major Target Limb Amputation | 19 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Thrombosis At Target Lesion Site | 73 Participants |
Secondary
Clinical Cohort ITT - MAEs
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.
Time frame: 12 months
Population: Event rates are based on number of evaluable subjects - subjects with at least one MAE event within 360-day or subjects without any MAE event but had at least 300 days of clinical follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | All MAE | 161 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | All cause death | 49 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | CD-TVR | 107 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Major Target Limb Amputation | 3 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Thrombosis at Target Lesion Site | 38 Participants |
Secondary
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time frame: 36 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | MAEs | 438 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | All cause deaths | 147 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | CD-TVR | 298 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Major Target Limb Amputation | 12 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Thrombosis at Target Lesion Site | 71 Participants |
Secondary
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time frame: 24 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | MAEs | 325 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Deaths | 101 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | CD-TVR | 224 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Major Target Limb Amputation | 9 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Thrombosis at Target Lesion Site | 57 Participants |
Secondary
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site
Time frame: 6 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | MAEs | 82 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Death | 23 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | CD-TVR | 54 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Major Target Limb Amputation | 3 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Thrombosis at Target Lesion Site | 28 Participants |
Secondary
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time frame: 48 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | MAEs | 517 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | All cause deaths | 196 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | CD-TVR | 342 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Major Target Limb Amputation | 15 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Thrombosis at Target Lesion Site | 71 Participants |
Secondary
Clinical Cohort ITT - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | MAEs | 19 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Death | 3 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | CD-TVR | 13 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Major Target Limb Amputation | 0 Participants |
| Clinical Cohort ITT | Clinical Cohort ITT - MAEs | Thrombosis at Target Lesion Site | 14 Participants |
Secondary
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Major Target Limb Amputation | 3 Participants |
Secondary
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 60 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Major Target Limb Amputation | 19 Participants |
Secondary
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Major Target Limb Amputation | 57 Participants |
Secondary
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Major Target Limb Amputation | 12 Participants |
Secondary
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Major Target Limb Amputation | 0 Participants |
Secondary
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Major Target Limb Amputation | 3 Participants |
Secondary
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Major Target Limb Amputation | 15 Participants |
Secondary
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Primary Sustained Clinical Improvement | 606 Participants |
Secondary
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Primary Sustained Clinical Improvement | 959 Participants |
Secondary
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Primary Sustained Clinical Improvement | 1068 Participants |
Secondary
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Primary Sustained Clinical Improvement | 745 Participants |
Secondary
Clinical Cohort ITT - Procedural Success
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Time frame: at procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Procedural Success | 1750 lesions |
Secondary
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Secondary Sustained Clinical Improvement | 1105 Participants |
Secondary
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Secondary Sustained Clinical Improvement | 1019 Participants |
Secondary
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Secondary Sustained Clinical Improvement | 876 Participants |
Secondary
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Secondary Sustained Clinical Improvement | 762 Participants |
Secondary
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Sustained Hemodynamic Improvement | 797 Participants |
Secondary
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Sustained Hemodynamic Improvement | 437 Participants |
Secondary
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Sustained Hemodynamic Improvement | 908 Participants |
Secondary
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Sustained Hemodynamic Improvement | 584 Participants |
Secondary
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months
Time frame: 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure. | 80.5 percentage of survival |
Secondary
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
Time frame: 60 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Time to First Clinically-driven TLR (Days) | 669.2 Days | Standard Deviation 462.5 |
Secondary
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TLR | 218 Participants |
Secondary
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TLR | 338 Participants |
Secondary
Clinical Cohort ITT - TLR
Time frame: 60 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TLR | 374 Participants |
Secondary
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TLR | 101 Participants |
Secondary
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TLR | 53 Participants |
Secondary
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TLR | 294 Participants |
Secondary
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TVR | 229 Participants |
Secondary
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Time frame: 36 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TVR | 305 Participants |
Secondary
Clinical Cohort ITT - TVR
Time frame: 60 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TVR | 390 Participants |
Secondary
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TVR | 56 Participants |
Secondary
Clinical Cohort ITT - TVR
Any Target vessel revascularisation
Time frame: 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TVR | 110 Participants |
Secondary
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Time frame: 48 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - TVR | 350 Participants |
Secondary
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 79.7 percentage of impairment | Standard Deviation 29 |
Secondary
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 36 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 74.4 percentage of impairment | Standard Deviation 30.6 |
Secondary
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 75.1 percentage of impairment | Standard Deviation 30.9 |
Secondary
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Cohort ITT | Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ) | 76.2 percentage of impairment | Standard Deviation 30.7 |
Secondary
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion
Time frame: at 12 months, or at the time of re-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion | 111 Participants |
Secondary
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion
Time frame: At 12 months, or at the time of re-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Cohort ITT | Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion | 71 Participants |