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

Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Common Iliac Artery Occlusive Disease; External Iliac Artery Occlusive Disease
• Intervention / Treatment: Device: Stenting of common and/or external iliacs

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Andrew Holden, MB ChB, Auckland City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): December 14, 2017

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: PAD; Stent; Claudication; Gore; Endoprosthesis; Vascular Diseases; Cardiovascular Diseases; Iliac Occlusive Disease; Balloon Expandable; VBX; Stent Graft; VIABAHN
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: VBX 13-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No