Trial Outcomes & Findings for GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study (NCT NCT00228384)
NCT ID: NCT00228384
Last Updated: 2012-06-04
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
148 participants
Primary outcome timeframe
3 years
Results posted on
2012-06-04
Participant Flow
Participant milestones
| Measure |
GORE VIABAHN Endoprosthesis
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
76
|
|
Overall Study
Baseline
|
72
|
76
|
|
Overall Study
30-Day Follow-up (Safety Outcome)
|
69
|
72
|
|
Overall Study
Three Year Follow-up (Final)
|
43
|
47
|
|
Overall Study
COMPLETED
|
43
|
47
|
|
Overall Study
NOT COMPLETED
|
29
|
29
|
Reasons for withdrawal
| Measure |
GORE VIABAHN Endoprosthesis
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Overall Study
Death
|
9
|
3
|
|
Overall Study
Lost to Follow-up
|
6
|
10
|
|
Overall Study
Surgical Intervention (bypass)
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
Baseline characteristics by cohort
| Measure |
GORE VIABAHN Endoprosthesis
n=72 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=76 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
69 years
n=5 Participants
|
63 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
76 participants
n=7 Participants
|
148 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPrimary 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).
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=72 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=76 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Efficacy: Primary Patency at Three Years
|
24.2 percentage of subjects
Interval 12.2 to 38.5
|
25.9 percentage of subjects
Interval 10.3 to 45.0
|
PRIMARY outcome
Timeframe: 30 daysMajor 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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=72 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=76 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)
|
1.4 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: 3 yearsPrimary 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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=72 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=76 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Primary Assisted Patency
|
69.8 percentage of subjects
Interval 53.5 to 81.3
|
88.8 percentage of subjects
Interval 78.0 to 94.5
|
SECONDARY outcome
Timeframe: 3 yearsSecondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=72 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=76 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Secondary Patency
|
79.5 percentage of subjects
Interval 62.6 to 89.4
|
89.3 percentage of subjects
Interval 77.7 to 95.1
|
SECONDARY outcome
Timeframe: Time of implant procedurePopulation: The number of participant analyzed were those for which we had data. Not all sites recorded both measures required to calculate technical success.
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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=69 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=69 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Technical Success at Initial Procedure
|
97.3 percentage of subjects
|
85.7 percentage of subjects
|
SECONDARY outcome
Timeframe: 3 yearsThis measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=72 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=76 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Target Vessel Revascularization (TVR)
|
37.5 percentage of participants
|
35.5 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsThis measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=72 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=76 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Target Lesion Revascularization (TLR)
|
34.7 percentage of participants
|
34.2 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The number of participants analyzed was the number of subjects that returned for the 3yr follow-up visit and for which we had data.
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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=45 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=48 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Improvement in Rutherford Classification (Clinical Success)
|
86.7 percentage of participants
|
91.7 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Number of subjects that returned for 3yr follow-up appointment and completed the ICQ.
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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=40 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=45 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)
Baseline
|
46.6 Score
Standard Deviation 20.1 • Interval 8.0 to 91.0
|
50.1 Score
Standard Deviation 18.2 • Interval 8.0 to 80.0
|
|
Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)
36month
|
20.8 Score
Standard Deviation 19.6
|
22.9 Score
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.
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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=39 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=45 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)
Baseline mean score
|
50.3 Score
Standard Deviation 12.8
|
48.3 Score
Standard Deviation 11.6
|
|
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)
36-month Mean
|
54 Score
Standard Deviation 9.1
|
54 Score
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.
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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=39 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=45 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)
Baseline Mean
|
33.6 Score
Standard Deviation 9.9 • Interval 14.0 to 59.0
|
32.9 Score
Standard Deviation 8.5 • Interval 14.0 to 51.0
|
|
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)
36-month Mean
|
41.9 Score
Standard Deviation 11.7 • Interval 21.0 to 61.0
|
38.7 Score
Standard Deviation 10.5 • Interval 16.0 to 59.0
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and had the ABI completed and recorded.
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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=46 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=44 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Change in Ankle-Brachial Index (ABI)
Baseline Mean
|
0.64 ABI Value
Standard Deviation 0.15
|
0.67 ABI Value
Standard Deviation 0.16
|
|
Change in Ankle-Brachial Index (ABI)
36-month Mean
|
0.95 ABI Value
Standard Deviation 0.18
|
0.97 ABI Value
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: 3 yearsThe 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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=72 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=76 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)
|
27.2 percentage of subjects
Interval 14.1 to 42.0
|
28.6 percentage of subjects
Interval 13.3 to 46.0
|
SECONDARY outcome
Timeframe: 3 yearsThe 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.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=72 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=76 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)
|
31.3 percentage of subjects
Interval 17.4 to 46.2
|
29.2 percentage of subjects
Interval 11.0 to 50.4
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The number of participants analyzed is the number of subjects that returned for the 1yr follow-up and completed the X-ray assessment.
The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=47 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=55 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Occurrence of Stent Fracture
|
2.1 percentage of particpants
|
32.7 percentage of particpants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The number of participants analyzed is the number of subjects that returned for the 2yr follow-up and completed the X-ray assessment.
The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=43 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=47 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Occurrence of Stent Fracture
|
4.7 percentage of participants
|
48.9 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the X-ray assessment.
The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.
Outcome measures
| Measure |
GORE VIABAHN Endoprosthesis
n=38 Participants
Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
|
Bare Nitinol Stent
n=42 Participants
Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
|
|---|---|---|
|
Occurrence of Stent Fracture
|
2.6 percentage of participants
|
50.0 percentage of participants
|
Adverse Events
GORE VIABAHN Endoprosthesis
Serious events: 25 serious events
Other events: 6 other events
Deaths: 0 deaths
Bare Nitinol Stent
Serious events: 24 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GORE VIABAHN Endoprosthesis
n=72 participants at risk
GORE VIABAHN Endoprosthesis
|
Bare Nitinol Stent
n=76 participants at risk
Bare Nitinol Stent
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Cardiac disorders
Acute chest pain
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Cardiac disorders
Cardiac tamponade
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Cardiac disorders
Cardiomyopathy NOS
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Cardiac disorders
Chest burning
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 2 • Throughout three-year study
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.
|
|
Cardiac disorders
Congestive heart failure
|
4.2%
3/72 • Number of events 4 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 2 • Throughout three-year study
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.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Cardiac disorders
Myocardial infarction
|
2.8%
2/72 • Number of events 3 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Cardiac disorders
Non-Q wave MI
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Cardiac disorders
Pulmonary edema
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Gastrointestinal disorders
GI bleed
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Gastrointestinal disorders
Internal hemorrhoids
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
General disorders
Acute chest pain
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
General disorders
Chest pain
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
General disorders
Device malfunction
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
General disorders
Implantable defibrillator malfunction
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
General disorders
Thrombosis in device
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Infections and infestations
Acute bronchitis
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Infections and infestations
Acute gastroenteritis
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Infections and infestations
Acute pyelonephritis
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 2 • Throughout three-year study
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.
|
|
Infections and infestations
Bronchitis NOS
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Infections and infestations
Candida oesophagitis
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Infections and infestations
Cellulitis of foot
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Infections and infestations
Cellulitis of hand
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Infections and infestations
Cellulitis of leg
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Infections and infestations
Influenza A virus infection
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Infections and infestations
Osteomyelitis NOS
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Infections and infestations
Septicemia due to Escherichia coli (E. coli)
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Infections and infestations
Staphylococcal septicemia
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Injury, poisoning and procedural complications
Incision site infection
|
2.8%
2/72 • Number of events 2 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain (with radiation)
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Musculoskeletal and connective tissue disorders
Calf pain
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Musculoskeletal and connective tissue disorders
Lumbar vertebral fracture L2
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Musculoskeletal and connective tissue disorders
Pain of lower extremities
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer NOS
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma of the lung
|
1.4%
1/72 • Number of events 3 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Nervous system disorders
Unilateral carpal tunnel syndrome
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Renal and urinary disorders
Acute renal insufficiency
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 2 • Throughout three-year study
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.
|
|
Renal and urinary disorders
Chronic renal insufficiency
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Renal and urinary disorders
Hematuria
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Surgical and medical procedures
AV fistula creation
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Surgical and medical procedures
Enucleation of eyeball
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Vascular disorders
Claudication
|
2.8%
2/72 • Number of events 2 • Throughout three-year study
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.
|
3.9%
3/76 • Number of events 3 • Throughout three-year study
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.
|
|
Vascular disorders
Coronary artery disease
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Vascular disorders
Coronary heart disease
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Vascular disorders
Critical limb ischemia
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
2.6%
2/76 • Number of events 2 • Throughout three-year study
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Vascular disorders
In-stent arterial restenosis
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Vascular disorders
Intermittent claudication
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Vascular disorders
Ischemic ulcer
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Vascular disorders
Leg ischemia
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/72 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Vascular disorders
Superficial femoral arterial stenosis
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
|
Vascular disorders
Vessel puncture site thrombosis
|
1.4%
1/72 • Number of events 1 • Throughout three-year study
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.
|
0.00%
0/76 • Throughout three-year study
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.
|
Other adverse events
| Measure |
GORE VIABAHN Endoprosthesis
n=72 participants at risk
GORE VIABAHN Endoprosthesis
|
Bare Nitinol Stent
n=76 participants at risk
Bare Nitinol Stent
|
|---|---|---|
|
General disorders
Vessel puncture site hematoma
|
4.2%
3/72 • Number of events 3 • Throughout three-year study
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.
|
1.3%
1/76 • Number of events 1 • Throughout three-year study
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.
|
|
Vascular disorders
Claudication
|
5.6%
4/72 • Number of events 8 • Throughout three-year study
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.
|
5.3%
4/76 • Number of events 4 • Throughout three-year study
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER