Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)

• ClinicalTrials.gov Identifier: NCT01961167
• Recruitment Status: Completed
• First Posted: October 11, 2013
• Results First Posted: November 6, 2019
• Last Update Posted: November 19, 2019
• Sponsor: W.L.Gore & Associates
• Information provided by (Responsible Party): W.L.Gore & Associates

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Common Iliac Artery Occlusive Disease; External Iliac Artery Occlusive Disease; Peripheral Arterial Disease	Device: Stenting of common and/or external iliacs	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single group assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries
• Actual Study Start Date: December 2013
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: December 14, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Gore VIABAHN BX; Balloon expandable stenting of iliac occlusive disease	Device: Stenting of common and/or external iliacs; Balloon expandable stenting of iliac occlusive disease

Outcome Measures

Primary Outcome Measures :

1. Composite of Major Adverse Events (MAEs) [ Time Frame: 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 Outcome Measures :

1. Acute Procedural Success [ Time Frame: 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.
2. Thirty-day Clinical Success [ Time Frame: 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

3. Primary Patency [ Time Frame: 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.
4. Primary Patency [ Time Frame: 6 Months ]
   Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention.
5. Primary Assisted Patency [ Time Frame: 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.
6. Primary Assisted Patency [ Time Frame: 6 Months ]
   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.
7. Secondary Patency [ Time Frame: 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.
8. Secondary Patency [ Time Frame: 6 Months ]
   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.
9. Freedom From Target Lesion(s) Revascularization (TLR) [ Time Frame: 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.
10. Freedom From Target Lesion(s) Revascularization (TLR) [ Time Frame: 6 Months ]
    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.
11. Freedom From Target Vessel Revascularization (TVR) [ Time Frame: 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.
12. Freedom From Target Vessel Revascularization (TVR) [ Time Frame: 6 Months ]
    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.
13. Number of Participants With a Change in Rutherford Category [ Time Frame: 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

14. Number of Participants With Change in Rutherford Category [ Time Frame: 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

15. Change in Ankle Brachial Index (ABI) [ Time Frame: 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
16. Change in Ankle Brachial Index (ABI) [ Time Frame: 6 Months ]
    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
17. Freedom From Major Adverse Events (MAEs) [ Time Frame: 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.
18. Change in Functional Status - EQ5D- Mobility [ Time Frame: 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.
19. Change in Functional Status - EQ5D- Mobility [ Time Frame: 6 Months ]
    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.
20. Change in Functional Status - EQ5D - Self Care [ Time Frame: 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.
21. Change in Functional Status - EQ5D - Self Care [ Time Frame: 6 Months ]
    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.
22. Change in Functional Status - EQ5D - Usual Activities [ Time Frame: 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.
23. Change in Functional Status - EQ5D - Usual Activities [ Time Frame: 6 Months ]
    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.
24. Change in Functional Status - EQ5D - Pain/Discomfort [ Time Frame: 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.
25. Change in Functional Status - EQ5D - Pain/Discomfort [ Time Frame: 6 Months ]
    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.
26. Change in Functional Status - EQ5D - Anxiety/Depression [ Time Frame: 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.
27. Change in Functional Status - EQ5D - Anxiety/Depression [ Time Frame: 6 Months ]
    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.
28. Change in Functional Status - EQ5D- Own Health State [ Time Frame: 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.
29. Change in Functional Status - EQ5D- Own Health State [ Time Frame: 6 Months ]
    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.
30. Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ) [ Time Frame: 30 day ]
    Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
31. Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ) [ Time Frame: 6 Months ]
    Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days.

Other Outcome Measures:

1. Device or Procedure-related Death [ Time Frame: 30 Days ]
   Number of subjects experiencing a device or procedure-related death within 30 days - component of primary outcome.
2. Freedom From Myocardial Infarction (MI) [ Time Frame: 30 Days ]
   Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome.
3. Freedom From Major Amputation of the Treated Leg(s) [ Time Frame: 6 Months ]
   Number of subjects experiencing a major amputation of the treated leg(s), resulting from a vascular event within 6 months - component

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

New Zealand

Auckland City Hospital

Auckland, New Zealand

Sponsors and Collaborators

W.L.Gore & Associates

Investigators

• Principal Investigator: Andrew Holden, MB ChB; Auckland City Hospital

More Information

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT01961167
• Other Study ID Numbers: VBX 13-05
• First Posted: October 11, 2013
• Results First Posted: November 6, 2019
• Last Update Posted: November 19, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by W.L.Gore & Associates:

PAD; Stent; Claudication; VIABAHN; Gore; Endoprosthesis; Vascular Diseases; Cardiovascular Diseases; Iliac Occlusive Disease; Balloon Expandable; Stent Graft; VBX

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases