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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gore VIABAHN BX | Experimental | Balloon expandable stenting of iliac occlusive disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stenting of common and/or external iliacs | Device | Balloon expandable stenting of iliac occlusive disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Major Adverse Events (MAEs) | Percentage of study subjects experiencing a major adverse event (MAE) defined as:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Discharge |
| Thirty-day Clinical Success |
| Measure | Description | Time Frame |
|---|---|---|
| Device or Procedure-related Death | Number of subjects experiencing a device or procedure-related death within 30 days - component of primary outcome. | 30 Days |
| Freedom From Myocardial Infarction (MI) | Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Holden, MB ChB | Auckland City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland City Hospital | Auckland | New Zealand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gore VIABAHN BX | Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects meeting all eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Iliac Stenting | Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite of Major Adverse Events (MAEs) | Percentage of study subjects experiencing a major adverse event (MAE) defined as:
| Population includes enrolled subjects who either experienced the defined event or were followed for at least 30 days. | Posted | Number | 95% Confidence Interval | percentage of subjects experiencing MAE | 30 days |
|
Through 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iliac Stenting | Balloon expandable stenting of iliac occlusive disease Stenting of common and/or external iliacs: Balloon expandable stenting of iliac occlusive disease |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial restenosis | Injury, poisoning and procedural complications | MedDRA Version 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Zambeck | W. L. Gore & Associates | 928-856-4900 | mzambeck@wlgore.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
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Single group assignment
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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 |
| 30 Days |
| 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. | 30 Days |
| 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. | 6 Months |
| 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. | 30 Days |
| 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. | 6 Months |
| 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. | 30 Days |
| 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. | 6 Months |
| 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. | 30 Days |
| 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. | 6 Months |
| 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. | 30 Days |
| 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. | 6 Months |
| 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 | 30 Days |
| 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 | 6 Months |
| 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 | 30 Days |
| 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 | 6 Months |
| 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. | 6 months |
| 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. | 30 days |
| 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. | 6 Months |
| 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. | 30 days |
| 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. | 6 Months |
| 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. | 30 days |
| 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. | 6 Months |
| 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. | 30 Days |
| 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. | 6 Months |
| 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. | 30 Days |
| 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. | 6 Months |
| 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. | 30 Days |
| 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. | 6 Months |
| 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. | 30 day |
| 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. | 6 Months |
| 30 Days |
| 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 | 6 Months |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Population includes subjects followed through discharge at day 1 and had relevant procedural data. | Posted | Count of Participants | Participants | Discharge |
|
|
|
| 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 | Population includes subjects followed for at least 30 days and had relevant data. | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| 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. | Analysis includes subjects followed for at least 30 days and had relevant data. | Posted | Number | 95% Confidence Interval | percentage of lesions | 30 Days |
|
|
|
| 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. | Population includes subjects followed for at least 180 days and had relevant data. | Posted | Number | 95% Confidence Interval | percentage of lesions | 6 Months |
|
|
|
| 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. | Population includes subjects followed for at least 30 days and had relevant data. | Posted | Number | 95% Confidence Interval | percentage of lesions | 30 Days |
|
|
|
| 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. | Population includes subjects followed for at least 180 days and had relevant data. | Posted | Number | 95% Confidence Interval | Lesions | 6 Months |
|
|
|
| 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. | Population includes subjects followed for at least 30 days and had relevant data. | Posted | Number | 95% Confidence Interval | percentage of lesions | 30 Days |
|
|
|
| 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. | Population includes subjects followed for at least 180 days and had relevant data. | Posted | Number | 95% Confidence Interval | percentage of lesions | 6 Months |
|
|
|
| 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. | Population includes subjects followed for at least 30 days. | Posted | Number | 95% Confidence Interval | percentage of lesions | 30 Days |
|
|
|
| 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. | Population includes subjects followed for at least 180 days. | Posted | Number | 95% Confidence Interval | percentage of lesions | 6 Months |
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| 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. | Population includes subjects followed for at least 30 days. | Posted | Number | 95% Confidence Interval | Vessel | 30 Days |
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| 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. | Population includes subjects followed for at least 180 days. | Posted | Number | 95% Confidence Interval | percentage of vessel | 6 Months |
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| 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 | Population includes subjects followed for at least 23 days and had relevant data. | Posted | Count of Participants | Participants | 30 Days |
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| 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 | Population includes subjects followed for at least 150 days and had relevant data. | Posted | Count of Participants | Participants | 6 Months |
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| 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 | Population includes subjects followed for at least 23 days and had relevant data. | Posted | Mean | Full Range | ratio | 30 Days | limbs | limbs |
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| 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 | Population includes subjects followed for at least 150 days and had relevant data. | Posted | Mean | Full Range | ratio | 6 Months | limbs | limbs |
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| 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. | Population includes number of subjects enrolled into the study who either had defined event or were followed for at least 150 days. | Posted | Count of Participants | Participants | 6 months |
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| 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. | Population includes subjects followed for at least 23 days and had relevant data. | Posted | Count of Participants | Participants | 30 days |
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| 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. | Patient population includes subjects followed for at least 150 days and had relevant data. | Posted | Count of Participants | Participants | 6 Months |
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| 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. | Population includes subjects followed for at least 23 days and had relevant data. | Posted | Count of Participants | Participants | 30 days |
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| 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. | Population includes subjects followed for at least 150 days and had relevant data. | Posted | Count of Participants | Participants | 6 Months |
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| 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. | Population includes subjects followed for at least 23 days and had relevant data. | Posted | Count of Participants | Participants | 30 days |
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| 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. | Population includes subjects followed for at least 150 days and had relevant data. | Posted | Count of Participants | Participants | 6 Months |
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| 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. | Population includes subjects followed for at least 30 days and had relevant data. | Posted | Count of Participants | Participants | 30 Days |
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| 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. | Population includes subjects followed for at least 150 days and had relevant data. | Posted | Count of Participants | Participants | 6 Months |
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| 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. | Population includes subjects followed for at least 30 days and had relevant data. | Posted | Count of Participants | Participants | 30 Days |
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| 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. | Population includes subjects followed for at least 150 days and had relevant data. | Posted | Count of Participants | Participants | 6 Months |
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| 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. | Population includes subjects followed for at least 30 days and had relevant data. | Posted | Count of Participants | Participants | 30 Days |
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| 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. | Population includes subjects followed for at least 150 days and had relevant data. | Posted | Count of Participants | Participants | 6 Months |
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| 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. | Population includes subjects followed for at least 30 days and had relevant data. | Posted | Count of Participants | Participants | 30 day |
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| 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. | Population includes subjects followed for at least 6 Months and had relevant data. | Posted | Count of Participants | Participants | 6 Months |
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| 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. | Population includes subjects followed for at least 30 days. | Posted | Count of Participants | Participants | 30 Days |
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| Other Pre-specified | Freedom From Myocardial Infarction (MI) | Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome. | Population includes subjects followed for at least 30 days. | Posted | Count of Participants | Participants | 30 Days |
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| 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 | Population includes subjects followed for at least 150 days. | Posted | Count of Participants | Participants | 6 Months |
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|
| 0 |
| 27 |
| 2 |
| 27 |
| 0 |
| 27 |
| Leg ischemia | Vascular disorders | MedDRA Version 19.0 | Systematic Assessment |
|
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |