Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00228384
Recruitment Status : Completed
First Posted : September 28, 2005
Results First Posted : May 28, 2012
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peripheral Vascular Diseases
Interventions Device: GORE VIABAHN Endoprosthesis
Device: Bare Nitinol Stent
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description Subjects randomized to this group received the Gore VIABAHN Endoprosthesis. Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Period Title: Overall Study
Started 72 76
Baseline 72 76
30-Day Follow-up (Safety Outcome) 69 72
Three Year Follow-up (Final) 43 47
Completed 43 47
Not Completed 29 29
Reason Not Completed
Death             9             3
Lost to Follow-up             6             10
Surgical Intervention (bypass)             5             5
Withdrawal by Subject             9             10
Physician Decision             0             1
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent Total
Hide Arm/Group Description Subjects randomized to this group received the Gore VIABAHN Endoprosthesis. Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care. Total of all reporting groups
Overall Number of Baseline Participants 72 76 148
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 72 participants 76 participants 148 participants
69
(45 to 90)
63
(43 to 89)
67
(43 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 76 participants 148 participants
Female
27
  37.5%
27
  35.5%
54
  36.5%
Male
45
  62.5%
49
  64.5%
94
  63.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants 76 participants 148 participants
72 76 148
1.Primary Outcome
Title Efficacy: Primary Patency at Three Years
Hide Description

Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention.

The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years).

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 72 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
24.2
(12.2 to 38.5)
25.9
(10.3 to 45.0)
2.Primary Outcome
Title Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)
Hide Description Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 72 76
Measure Type: Number
Unit of Measure: percentage of subjects
1.4 0
3.Secondary Outcome
Title Primary Assisted Patency
Hide Description Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 72 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
69.8
(53.5 to 81.3)
88.8
(78.0 to 94.5)
4.Secondary Outcome
Title Secondary Patency
Hide Description Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 72 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
79.5
(62.6 to 89.4)
89.3
(77.7 to 95.1)
5.Secondary Outcome
Title Technical Success at Initial Procedure
Hide Description

Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with < 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow.

The results show the percentage of study subjects that had technical success.

Time Frame Time of implant procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participant analyzed were those for which we had data. Not all sites recorded both measures required to calculate technical success.
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 69 69
Measure Type: Number
Unit of Measure: percentage of subjects
97.3 85.7
6.Secondary Outcome
Title Target Vessel Revascularization (TVR)
Hide Description This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 72 76
Measure Type: Number
Unit of Measure: percentage of participants
37.5 35.5
7.Secondary Outcome
Title Target Lesion Revascularization (TLR)
Hide Description This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 72 76
Measure Type: Number
Unit of Measure: percentage of participants
34.7 34.2
8.Secondary Outcome
Title Improvement in Rutherford Classification (Clinical Success)
Hide Description

The Rutherford Classification is a system used to score Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication 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

The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed was the number of subjects that returned for the 3yr follow-up visit and for which we had data.
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 45 48
Measure Type: Number
Unit of Measure: percentage of participants
86.7 91.7
9.Secondary Outcome
Title Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)
Hide Description

The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire.

Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects that returned for 3yr follow-up appointment and completed the ICQ.
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 40 45
Mean (Standard Deviation)
Unit of Measure: Score
Baseline 46.6  (20.1) 50.1  (18.2)
36month 20.8  (19.6) 22.9  (21.2)
10.Secondary Outcome
Title Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)
Hide Description

The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.

The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 39 45
Mean (Standard Deviation)
Unit of Measure: Score
Baseline mean score 50.3  (12.8) 48.3  (11.6)
36-month Mean 54  (9.1) 54  (8.6)
11.Secondary Outcome
Title Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)
Hide Description

The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.

The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 39 45
Mean (Standard Deviation)
Unit of Measure: Score
Baseline Mean 33.6  (9.9) 32.9  (8.5)
36-month Mean 41.9  (11.7) 38.7  (10.5)
12.Secondary Outcome
Title Change in Ankle-Brachial Index (ABI)
Hide Description

This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.

A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal.

An outcome of a higher mean ABI is considered a success.

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and had the ABI completed and recorded.
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: ABI Value
Baseline Mean 0.64  (0.15) 0.67  (0.16)
36-month Mean 0.95  (0.18) 0.97  (0.16)
13.Secondary Outcome
Title Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)
Hide Description The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 2.5.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 72 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
27.2
(14.1 to 42.0)
28.6
(13.3 to 46.0)
14.Secondary Outcome
Title Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)
Hide Description The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 3.0.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 72 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
31.3
(17.4 to 46.2)
29.2
(11.0 to 50.4)
15.Secondary Outcome
Title Occurrence of Stent Fracture
Hide Description The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number of subjects that returned for the 1yr follow-up and completed the X-ray assessment.
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 47 55
Measure Type: Number
Unit of Measure: percentage of particpants
2.1 32.7
16.Secondary Outcome
Title Occurrence of Stent Fracture
Hide Description The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number of subjects that returned for the 2yr follow-up and completed the X-ray assessment.
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 43 47
Measure Type: Number
Unit of Measure: percentage of participants
4.7 48.9
17.Secondary Outcome
Title Occurrence of Stent Fracture
Hide Description The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the X-ray assessment.
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description:
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Overall Number of Participants Analyzed 38 42
Measure Type: Number
Unit of Measure: percentage of participants
2.6 50.0
Time Frame Throughout three-year study
Adverse Event Reporting Description At each scheduled and unscheduled visit, subjects were asked about their health and if there were any changes to baseline. If so, this was recorded on a Case Report Form and reported to the Sponsor.
 
Arm/Group Title GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Hide Arm/Group Description GORE VIABAHN Endoprosthesis Bare Nitinol Stent
All-Cause Mortality
GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/72 (34.72%)      24/76 (31.58%)    
Blood and lymphatic system disorders     
Anemia  1  1/72 (1.39%)  1 1/76 (1.32%)  1
Cardiac disorders     
Acute chest pain  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Acute myocardial infarction  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Atrial fibrillation  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Cardiac tamponade  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Cardio-respiratory arrest  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Cardiomyopathy NOS  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Chest burning  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Congestive cardiac failure aggravated  1  0/72 (0.00%)  0 1/76 (1.32%)  2
Congestive heart failure  1  3/72 (4.17%)  4 1/76 (1.32%)  2
Coronary artery disease  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Hypertensive heart disease  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Myocardial infarction  1  2/72 (2.78%)  3 1/76 (1.32%)  1
Non-Q wave MI  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Pulmonary edema  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Ventricular tachycardia  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Gastrointestinal disorders     
GI bleed  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Internal hemorrhoids  1  1/72 (1.39%)  1 0/76 (0.00%)  0
General disorders     
Acute chest pain  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Chest pain  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Device malfunction  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Implantable defibrillator malfunction  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Thrombosis in device  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Infections and infestations     
Acute bronchitis  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Acute gastroenteritis  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Acute pyelonephritis  1  0/72 (0.00%)  0 1/76 (1.32%)  2
Bronchitis NOS  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Candida oesophagitis  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Cellulitis gangrenous  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Cellulitis of foot  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Cellulitis of hand  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Cellulitis of leg  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Influenza A virus infection  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Osteomyelitis NOS  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Pneumonia  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Pneumonia respiratory syncytial viral  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Septicemia due to Escherichia coli (E. coli)  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Staphylococcal septicemia  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Urinary tract infection  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Urosepsis  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Injury, poisoning and procedural complications     
Femoral neck fracture  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Hip fracture  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Incision site infection  1  2/72 (2.78%)  2 0/76 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain (with radiation)  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Calf pain  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Low back pain  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Lumbar vertebral fracture L2  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Pain of lower extremities  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer NOS  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Small cell carcinoma of the lung  1  1/72 (1.39%)  3 1/76 (1.32%)  1
Nervous system disorders     
Subarachnoid hemorrhage  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Unilateral carpal tunnel syndrome  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Renal and urinary disorders     
Acute renal insufficiency  1  0/72 (0.00%)  0 1/76 (1.32%)  2
Chronic renal insufficiency  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Hematuria  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chest pain  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Emphysema  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Hemoptysis  1  1/72 (1.39%)  1 1/76 (1.32%)  1
Pulmonary embolism  1  1/72 (1.39%)  1 1/76 (1.32%)  1
Respiratory failure  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Surgical and medical procedures     
AV fistula creation  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Enucleation of eyeball  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Vascular disorders     
Claudication  1  2/72 (2.78%)  2 3/76 (3.95%)  3
Coronary artery disease  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Coronary heart disease  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Critical limb ischemia  1  1/72 (1.39%)  1 2/76 (2.63%)  2
Hypotension  1  0/72 (0.00%)  0 1/76 (1.32%)  1
In-stent arterial restenosis  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Intermittent claudication  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Ischemic ulcer  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Leg ischemia  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Peripheral artery occlusion  1  0/72 (0.00%)  0 1/76 (1.32%)  1
Superficial femoral arterial stenosis  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Vessel puncture site thrombosis  1  1/72 (1.39%)  1 0/76 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.0%
GORE VIABAHN Endoprosthesis Bare Nitinol Stent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/72 (8.33%)      4/76 (5.26%)    
General disorders     
Vessel puncture site hematoma  1  3/72 (4.17%)  3 1/76 (1.32%)  1
Vascular disorders     
Claudication  1  4/72 (5.56%)  8 4/76 (5.26%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator will provide the materials to the sponsor at least 30 days in advance of submission for publication or public disclosure. The sponsor has the right to make modifications as necessary to protect proprietary information or correct inaccuracies in technical specifications or device descriptions.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chad Badorek
Organization: W. L. Gore & Associates, Inc.
Phone: 800/437-8181
EMail: cbadorek@wlgore.com
Layout table for additonal information
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00228384    
Other Study ID Numbers: SFA 05-03
First Submitted: September 26, 2005
First Posted: September 28, 2005
Results First Submitted: January 27, 2012
Results First Posted: May 28, 2012
Last Update Posted: June 4, 2012