Common Iliac Artery Occlusive Disease, External Iliac Artery Occlusive Disease, Peripheral Arterial Disease
Conditions
Keywords
PAD, Stent, Claudication, VIABAHN, Gore, Endoprosthesis, Vascular Diseases, Cardiovascular Diseases, Iliac Occlusive Disease, Balloon Expandable, Stent Graft, VBX
Brief summary
The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
Interventions
DEVICEStenting of common and/or external iliacs
Balloon expandable stenting of iliac occlusive disease
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at least 18 years old; * Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy; * Patient or legal representative is willing to give written informed consent; * Patient is capable of complying with protocol requirements, including all follow-up visits; * Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4). * Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery
Exclusion criteria
* Patient has a life expectancy of less than 1 year; * Patient has a known allergy to stent graft components, including stainless steel or heparin; * Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol; * Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation * Patient has had vascular access / catheterization in the lower extremity within 30 days of study enrollment; * Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure; Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the study procedure; * Patient is currently participating in this or another investigative clinical study. * Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s); * Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device; * Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery; * Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Major Adverse Events (MAEs) | 30 days | Percentage of study subjects experiencing a major adverse event (MAE) defined as: * Device- or procedure-related death within 30 days of the index procedure; and * Myocardial Infarction (MI) occurring within 30 days of the index procedure; and * Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Target Vessel Revascularization (TVR) | 30 Days | Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means. |
| Change in Functional Status - EQ5D - Pain/Discomfort | 30 Days | Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome. |
| Change in Functional Status - EQ5D - Anxiety/Depression | 30 Days | Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome. |
| Change in Functional Status - EQ5D- Own Health State | 30 Days | Change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome. |
| Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ) | 30 day | Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days. |
| Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ) | 6 Months | Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days. |
| Acute Procedural Success | Discharge | Number of subjects who experience acute procedural success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge at day 1. |
| Thirty-day Clinical Success | 30 Days | Number of subjects who experienced 30-day clinical success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related serious adverse events (SAEs) within 30 days of the index procedure. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
| Primary Patency | 30 Days | Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention. |
| Primary Assisted Patency | 30 Days | Kaplan-Meier estimate of primary assisted patency at 30 days. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins. |
| Secondary Patency | 30 Days | Kaplan-Meier estimate of secondary patency at 30 days. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins. |
| Freedom From Target Lesion(s) Revascularization (TLR) | 30 Days | Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means. |
| Number of Participants With a Change in Rutherford Category | 30 Days | Change in Rutherford Category from pre-procedure at 30 days. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
| Number of Participants With Change in Rutherford Category | 6 Months | Change in Rutherford Category from pre-procedure at 6 months. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene |
| Change in Ankle Brachial Index (ABI) | 30 Days | Change in Ankle Brachial Index (ABI) from pre-procedure at 30 days. Larger values indicate a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm |
| Freedom From Major Adverse Events (MAEs) | 6 months | Number of subjects experiencing freedom from procedure- or device-related events causing death, occurring within 30 days of the index procedure; and myocardial infarction (MI) occurring within 30 days of the index procedure; and target lesion revascularization (TLR) occurring within 6 months of the index procedure; and major amputation of the treated leg(s), resulting from a vascular event, occurring within 6 months of the index procedure. |
| Change in Functional Status - EQ5D- Mobility | 30 days | Change in functional status (EQ5D - Mobility) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome. |
| Change in Functional Status - EQ5D - Self Care | 30 days | Change in functional status (EQ5D - Self Care) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome. |
| Change in Functional Status - EQ5D - Usual Activities | 30 days | Change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device or Procedure-related Death | 30 Days | Number of subjects experiencing a device or procedure-related death within 30 days - component of primary outcome. |
| Freedom From Myocardial Infarction (MI) | 30 Days | Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome. |
| Freedom From Major Amputation of the Treated Leg(s) | 6 Months | Number of subjects experiencing a major amputation of the treated leg(s), resulting from a vascular event within 6 months - component |
Countries
New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iliac Stenting Balloon expandable stenting of iliac occlusive disease
Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Iliac Stenting |
|---|---|
| Age, Continuous | 65 Years STANDARD_DEVIATION 8.4 |
| Region of Enrollment New Zealand | 27 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 2 / 27 |
Outcome results
Primary
Composite of Major Adverse Events (MAEs)
Percentage of study subjects experiencing a major adverse event (MAE) defined as: * Device- or procedure-related death within 30 days of the index procedure; and * Myocardial Infarction (MI) occurring within 30 days of the index procedure; and * Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure.
Time frame: 30 days
Population: Population includes enrolled subjects who either experienced the defined event or were followed for at least 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Composite of Major Adverse Events (MAEs) | 0 percentage of subjects experiencing MAE |
Secondary
Acute Procedural Success
Number of subjects who experience acute procedural success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge at day 1.
Time frame: Discharge
Population: Population includes subjects followed through discharge at day 1 and had relevant procedural data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iliac Stenting | Acute Procedural Success | 27 Participants |
Secondary
Change in Ankle Brachial Index (ABI)
Change in Ankle Brachial Index(ABI) from pre-procedure at 6 months. Larger values indicate a better outcome.The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm
Time frame: 6 Months
Population: Population includes subjects followed for at least 150 days and had relevant data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Iliac Stenting | Change in Ankle Brachial Index (ABI) | .15 ratio |
Secondary
Change in Ankle Brachial Index (ABI)
Change in Ankle Brachial Index (ABI) from pre-procedure at 30 days. Larger values indicate a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm
Time frame: 30 Days
Population: Population includes subjects followed for at least 23 days and had relevant data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Iliac Stenting | Change in Ankle Brachial Index (ABI) | .15 ratio |
Secondary
Change in Functional Status - EQ5D - Anxiety/Depression
Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 6 Months
Population: Population includes subjects followed for at least 150 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D - Anxiety/Depression | Improved | 2 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Anxiety/Depression | Maintained | 21 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Anxiety/Depression | Worsened | 0 Participants |
Secondary
Change in Functional Status - EQ5D - Anxiety/Depression
Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D - Anxiety/Depression | Improved | 5 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Anxiety/Depression | Maintained | 20 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Anxiety/Depression | Worsened | 1 Participants |
Secondary
Change in Functional Status - EQ5D- Mobility
Change in functional status (EQ5D - Mobility) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 30 days
Population: Population includes subjects followed for at least 23 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D- Mobility | Improved | 12 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D- Mobility | Maintained | 12 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D- Mobility | Worsened | 2 Participants |
Secondary
Change in Functional Status - EQ5D- Mobility
Change in functional status (EQ5D - Mobility) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 6 Months
Population: Patient population includes subjects followed for at least 150 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D- Mobility | Improved | 10 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D- Mobility | Maintained | 10 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D- Mobility | Worsened | 3 Participants |
Secondary
Change in Functional Status - EQ5D- Own Health State
Change in functional status (EQ5D - Own Health State) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 6 Months
Population: Population includes subjects followed for at least 150 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D- Own Health State | Worsened | 2 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D- Own Health State | Improved | 3 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D- Own Health State | Maintained | 17 Participants |
Secondary
Change in Functional Status - EQ5D- Own Health State
Change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D- Own Health State | Improved | 4 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D- Own Health State | Maintained | 19 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D- Own Health State | Worsened | 2 Participants |
Secondary
Change in Functional Status - EQ5D - Pain/Discomfort
Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 6 Months
Population: Population includes subjects followed for at least 150 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D - Pain/Discomfort | Improved | 10 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Pain/Discomfort | Maintained | 12 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Pain/Discomfort | Worsened | 1 Participants |
Secondary
Change in Functional Status - EQ5D - Pain/Discomfort
Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D - Pain/Discomfort | Improved | 14 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Pain/Discomfort | Maintained | 10 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Pain/Discomfort | Worsened | 2 Participants |
Secondary
Change in Functional Status - EQ5D - Self Care
Change in functional status (EQ5D - Self Care) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 30 days
Population: Population includes subjects followed for at least 23 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D - Self Care | Maintained | 26 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Self Care | Worsened | 0 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Self Care | Improved | 0 Participants |
Secondary
Change in Functional Status - EQ5D - Self Care
Change in functional status (EQ5D - Self Care) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 6 Months
Population: Population includes subjects followed for at least 150 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D - Self Care | Improved | 0 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Self Care | Maintained | 22 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Self Care | Worsened | 1 Participants |
Secondary
Change in Functional Status - EQ5D - Usual Activities
Change in functional status (EQ5D - Usual Activities) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 6 Months
Population: Population includes subjects followed for at least 150 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D - Usual Activities | Maintained | 14 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Usual Activities | Worsened | 1 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Usual Activities | Improved | 8 Participants |
Secondary
Change in Functional Status - EQ5D - Usual Activities
Change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.
Time frame: 30 days
Population: Population includes subjects followed for at least 23 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Change in Functional Status - EQ5D - Usual Activities | Improved | 13 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Usual Activities | Maintained | 12 Participants |
| Iliac Stenting | Change in Functional Status - EQ5D - Usual Activities | Worsened | 1 Participants |
Secondary
Freedom From Major Adverse Events (MAEs)
Number of subjects experiencing freedom from procedure- or device-related events causing death, occurring within 30 days of the index procedure; and myocardial infarction (MI) occurring within 30 days of the index procedure; and target lesion revascularization (TLR) occurring within 6 months of the index procedure; and major amputation of the treated leg(s), resulting from a vascular event, occurring within 6 months of the index procedure.
Time frame: 6 months
Population: Population includes number of subjects enrolled into the study who either had defined event or were followed for at least 150 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iliac Stenting | Freedom From Major Adverse Events (MAEs) | 27 Participants |
Secondary
Freedom From Target Lesion(s) Revascularization (TLR)
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 6 months. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Time frame: 6 Months
Population: Population includes subjects followed for at least 180 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Freedom From Target Lesion(s) Revascularization (TLR) | 100 percentage of lesions |
Secondary
Freedom From Target Lesion(s) Revascularization (TLR)
Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Freedom From Target Lesion(s) Revascularization (TLR) | 100 percentage of lesions |
Secondary
Freedom From Target Vessel Revascularization (TVR)
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 6 months. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Time frame: 6 Months
Population: Population includes subjects followed for at least 180 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Freedom From Target Vessel Revascularization (TVR) | 100 percentage of vessel |
Secondary
Freedom From Target Vessel Revascularization (TVR)
Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Freedom From Target Vessel Revascularization (TVR) | 100 Vessel |
Secondary
Number of Participants With a Change in Rutherford Category
Change in Rutherford Category from pre-procedure at 30 days. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Time frame: 30 Days
Population: Population includes subjects followed for at least 23 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Number of Participants With a Change in Rutherford Category | Improved | 25 Participants |
| Iliac Stenting | Number of Participants With a Change in Rutherford Category | Maintained | 1 Participants |
| Iliac Stenting | Number of Participants With a Change in Rutherford Category | Worsened | 1 Participants |
Secondary
Number of Participants With Change in Rutherford Category
Change in Rutherford Category from pre-procedure at 6 months. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Time frame: 6 Months
Population: Population includes subjects followed for at least 150 days and had relevant data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iliac Stenting | Number of Participants With Change in Rutherford Category | Improved | 19 Participants |
| Iliac Stenting | Number of Participants With Change in Rutherford Category | Maintained | 1 Participants |
| Iliac Stenting | Number of Participants With Change in Rutherford Category | Worsended | 2 Participants |
Secondary
Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)
Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days.
Time frame: 6 Months
Population: Population includes subjects followed for at least 6 Months and had relevant data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iliac Stenting | Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ) | 17 Participants |
Secondary
Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)
Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
Time frame: 30 day
Population: Population includes subjects followed for at least 30 days and had relevant data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iliac Stenting | Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ) | 20 Participants |
Secondary
Primary Assisted Patency
Kaplan-Meier estimate of primary assisted patency at 30 days. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days and had relevant data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Primary Assisted Patency | 100 percentage of lesions |
Secondary
Primary Assisted Patency
Kaplan-Meier estimate of primary assisted patency at 6 Months. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.
Time frame: 6 Months
Population: Population includes subjects followed for at least 180 days and had relevant data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Primary Assisted Patency | 100 Lesions |
Secondary
Primary Patency
Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention.
Time frame: 6 Months
Population: Population includes subjects followed for at least 180 days and had relevant data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Primary Patency | 100 percentage of lesions |
Secondary
Primary Patency
Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention.
Time frame: 30 Days
Population: Analysis includes subjects followed for at least 30 days and had relevant data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Primary Patency | 100 percentage of lesions |
Secondary
Secondary Patency
Kaplan-Meier estimate of secondary patency at 30 days. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days and had relevant data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Secondary Patency | 100 percentage of lesions |
Secondary
Secondary Patency
Kaplan-Meier estimate of secondary patency at 6 months. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.
Time frame: 6 Months
Population: Population includes subjects followed for at least 180 days and had relevant data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iliac Stenting | Secondary Patency | 100 percentage of lesions |
Secondary
Thirty-day Clinical Success
Number of subjects who experienced 30-day clinical success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related serious adverse events (SAEs) within 30 days of the index procedure. Rutherford categories include: Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters. Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days and had relevant data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iliac Stenting | Thirty-day Clinical Success | 25 Participants |
Other Pre-specified
Device or Procedure-related Death
Number of subjects experiencing a device or procedure-related death within 30 days - component of primary outcome.
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iliac Stenting | Device or Procedure-related Death | 0 Participants |
Other Pre-specified
Freedom From Major Amputation of the Treated Leg(s)
Number of subjects experiencing a major amputation of the treated leg(s), resulting from a vascular event within 6 months - component
Time frame: 6 Months
Population: Population includes subjects followed for at least 150 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iliac Stenting | Freedom From Major Amputation of the Treated Leg(s) | 0 Participants |
Other Pre-specified
Freedom From Myocardial Infarction (MI)
Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome.
Time frame: 30 Days
Population: Population includes subjects followed for at least 30 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iliac Stenting | Freedom From Myocardial Infarction (MI) | 0 Participants |