A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.

Peripheral Arterial Disease Clinical Trial

— VBXFLEX  

Official title:

Evaluation of the Gore(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080871
• Other study ID #: BES 10-07
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: October 2018

Study information

• Verified date: December 2018
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.

Description:

This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 2018
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is at least 18 years old;

2. Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;

3. Patient or legal representative is willing to give written informed consent;

4. Patient is capable of complying with protocol requirements, including all follow-up visits;

5. Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).

6. Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery;

7. Patient has one or more regions of stenosis = 50% in the target vessel, based on visual estimate;

8. Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;

9. Patient has adequate ipsilateral blood flow including at least one sufficient (<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on).

10. Patient has a total target lesion length visually estimated to be =110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses;

11. Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses [OR] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses;

12. Patient has the device advanced across the target lesion(s) and positioned for deployment.

Exclusion Criteria:

1. Patient has a life expectancy of less than 1 year;

2. Patient has a known allergy to stent graft components, including stainless steel or heparin;

3. Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;

4. Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation

5. Patient has an uncorrected bleeding disorder (platelet count < 80,000/µL);

6. Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not on hemodialysis;

7. Patient has a known hypercoagulability that cannot be corrected;

8. Patient has evidence of a blood borne infection;

9. Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment;

10. 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;

11. Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure;

12. Patient is currently participating in this or another investigative clinical study.

13. Patient has a stent or stent graft located within or immediately adjacent (=5mm) to study lesion(s);

14. Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);

15. Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;

16. Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;

17. 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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Stenting of the Common and/or External Iliac Arteries
Balloon expandable stenting of iliac occlusive disease.

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Auckland
United States	Research Foundation SUNY Buffalo	Buffalo	New York
United States	Holy Spirit Cardiovascular Institute	Camp Hill	Pennsylvania
United States	MUSC	Charleston	South Carolina
United States	University Surgical Associates	Chattanooga	Tennessee
United States	Ohio Health	Columbus	Ohio
United States	Essentia Institute for Rural Health / St Mary's Hospital	Duluth	Minnesota
United States	Cardiovascular Associates	Elk Grove Village	Illinois
United States	Sanford Clinic - Clinical Research	Fargo	North Dakota
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	The Methodist Hospital	Houston	Texas
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	University of Louisville	Louisville	Kentucky
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Advanced Vascular Associates	Morristown	New Jersey
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Cornell University	New York	New York
United States	Sentara Medical Group	Norfolk	Virginia
United States	Coastal Vascular Institute	Pensacola	Florida
United States	St. Luke's Medical Center	Phoenix	Arizona
United States	UPMC	Pittsburgh	Pennsylvania
United States	North Memorial Heart & Vascular Institute	Plymouth	Minnesota
United States	The Miriam Hospital	Providence	Rhode Island
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	MedStar Health Research Institute	Washington	District of Columbia
United States	Iowa Methodist Medical Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device or Procedure-related Death	Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome	30 Days
Other	Myocardial Infarction (MI)	Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome	30 Days
Other	Target Lesion Revascularization (TLR)	Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome	9 Months
Other	Major Amputation	Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome	9 Months
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, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.	9 months
Secondary	Acute Procedural Success	Number of subjects who experienced 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.	Discharge
Secondary	30-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 SAEs within 30 days of the index procedure.	30 Days
Secondary	Percentage of Participants With Primary Patency	Kaplan-Meier estimate of primary patency at 30 days.	30 Days
Secondary	Percentage of Participants With Primary Patency	Kaplan-Meier estimate of primary patency at 9 months.	9 Months
Secondary	Percentage of Participants With Primary Assisted Patency	Kaplan-Meier estimate of primary assisted patency at 30 days.	30 Days
Secondary	Percentage of Participants With Primary Assisted Patency	Kaplan-Meier estimate of primary assisted patency at 9 months.	9 Months
Secondary	Percentage of Participants With Secondary Patency	Kaplan-Meier estimate of secondary patency at 30 days.	30 Days
Secondary	Percentage of Participants With Secondary Patency	Kaplan-Meier estimate of secondary patency at 9 months.	9 Months
Secondary	Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.	30 Days
Secondary	Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.	9 Months
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.	30 Days
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.	9 Months
Secondary	Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.	30 Days
Secondary	Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.	9 Months
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.	30 Days
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months	9 Months
Secondary	Number of Participants With Change in Rutherford Category	Number of participants with change in Rutherford Category from pre-procedure at 30 days.; Rutherford Categories: 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
Secondary	Number of Participants With Change in Rutherford Category	Number of participants with change in Rutherford Category from pre-procedure at 9 months.; Rutherford Categories: 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	9 Months
Secondary	Change in Ankle Brachial Index (ABI)	Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.	30 Days
Secondary	Change in Ankle Brachial Index (ABI)	Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.	9 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Mobility	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.	30 Days
Secondary	Number of Participants With Change in Functional Status - EQ5D - Mobility	Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.	9 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Self Care	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.	30 Days
Secondary	Number of Participants With Change in Functional Status - EQ5D - Self Care	Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.	9 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.	30 Days
Secondary	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.	9 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.	30 Days
Secondary	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.	9 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.	30 Days
Secondary	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.	9 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.	30 Days
Secondary	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.	9 Months
Secondary	Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)	Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.	30 Days
Secondary	Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)	Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.	9 Months
Secondary	Percentage of Participants With Primary Patency	Kaplan-Meier estimate of primary patency at 12 months.	12 Months
Secondary	Percentage of Participants With Primary Assisted Patency	Kaplan-Meier estimate of primary assisted patency at 12 months.	12 Months
Secondary	Percentage of Participants With Secondary Patency	Kaplan-Meier estimate of secondary patency at 12 months.	12 Months
Secondary	Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.	12 Months
Secondary	Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.	24 Months
Secondary	Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.	36 Months
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.	12 Months
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months.	24 Months
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months.	36 Months
Secondary	Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.	12 Months
Secondary	Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.	24 Months
Secondary	Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.	36 Months
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months	12 Months
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months	24 Months
Secondary	Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months	36 Months
Secondary	Number of Participants With Change in Rutherford Category	Number of participants with change in Rutherford Category from pre-procedure at 12 months.; Rutherford Categories: 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	12 Months
Secondary	Number of Participants With Change in Rutherford Category	Number of participants with change in Rutherford Category from pre-procedure at 24 months.; Rutherford Categories: 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	24 Months
Secondary	Number of Participants With Change in Rutherford Category	Number of participants with change in Rutherford Category from pre-procedure at 36 months.; Rutherford Categories: 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	36 Months
Secondary	Change in Ankle Brachial Index (ABI)	Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.	12 Months
Secondary	Change in Ankle Brachial Index (ABI)	Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.	24 Months
Secondary	Change in Ankle Brachial Index (ABI)	Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.	36 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Mobility	Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months.	12 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Mobility	Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months.	24 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Mobility	Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months.	36 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Self Care	Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months.	12 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Self Care	Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months.	24 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Self Care	Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months.	36 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months.	12 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months.	24 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months.	36 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months.	12 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months.	24 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months.	36 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months.	12 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months.	24 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months.	36 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months.	12 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months.	24 Months
Secondary	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months.	36 Months