Trial Outcomes & Findings for GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER) (NCT NCT00541307)

Last Updated: 2012-12-27

Results Overview

Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area).

Recruitment status

COMPLETED

Study phase

Target enrollment

119 participants

Primary outcome timeframe

12 months

Results posted on

2012-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Gore Viabahn Endoprosthesis All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
Overall Study STARTED	119
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Gore Viabahn Endoprosthesis All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
Overall Study Death	5
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	4
Overall Study Subject returned early (outside window)	1
Overall Study Surgical Bypass	5

Baseline Characteristics

GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled Subjects n=119 Participants The total number of enrolled subjects.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=93 Participants
Age, Categorical >=65 years	61 Participants n=93 Participants
Age Continuous	66 years STANDARD_DEVIATION 9.6 • n=93 Participants
Sex: Female, Male Female	45 Participants n=93 Participants
Sex: Female, Male Male	74 Participants n=93 Participants
Region of Enrollment United States	119 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Gore Viabahn Endoprosthesis n=119 Participants All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
Primary Patency at 12 Months	72.9 percentage of subjects Interval 62.9 to 80.6

SECONDARY outcome

Timeframe: 30 days

If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.

Outcome measures

Outcome measures
Measure	Gore Viabahn Endoprosthesis n=119 Participants All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days	0 participants

SECONDARY outcome

Timeframe: 12 months

Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency.

Outcome measures

Outcome measures
Measure	Gore Viabahn Endoprosthesis n=119 Participants All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
Primary Assisted Patency	85.6 percentage of subjects Interval 77.2 to 91.1

SECONDARY outcome

Timeframe: 12 months

Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency.

Outcome measures

Outcome measures
Measure	Gore Viabahn Endoprosthesis n=119 Participants All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
Secondary Patency	92.2 percentage of subjects Interval 84.9 to 96.0

SECONDARY outcome

Timeframe: 12 months

If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.

Outcome measures

Outcome measures
Measure	Gore Viabahn Endoprosthesis n=119 Participants All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
Device-related Major Adverse Events at 12 Months	1 event

Adverse Events

Gore VIABAHN Endoprosthesis With Heparin Bioactive Surface

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gore VIABAHN Endoprosthesis With Heparin Bioactive Surface n=119 participants at risk Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
Cardiac disorders Acute myocardial infarction, unspecified site	0.84% 1/119 • Number of events 1
Gastrointestinal disorders Ileus	0.84% 1/119 • Number of events 1
General disorders Death	0.84% 1/119 • Number of events 1
Infections and infestations Pneumonia	0.84% 1/119 • Number of events 1
Renal and urinary disorders Chronic renal failure	0.84% 1/119 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleurisy	0.84% 1/119 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.84% 1/119 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.84% 1/119 • Number of events 1
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.84% 1/119 • Number of events 1
Vascular disorders Claudication	0.84% 1/119 • Number of events 1
Vascular disorders Femoral artery embolism	0.84% 1/119 • Number of events 1
Vascular disorders Intermittent claudication	0.84% 1/119 • Number of events 1
Vascular disorders Ischemic leg ulcer	0.84% 1/119 • Number of events 1
Vascular disorders Thrombosis in device	1.7% 2/119 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Chad Badorek

W. L. Gore & Associates, Inc.

Phone: 928/437-8181

Email: [email protected]

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