Trial Outcomes & Findings for The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses (NCT NCT01406795)

Results Overview

Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

up to 1 month following the procedure

Results posted on

2017-02-27

Participant Flow

The study recruited a single patient in 2012 at the Stanford Medical Center. The study ended in 2013.

Participant milestones

Participant milestones
Measure	Venous Stent Arm The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Venous Stent Arm The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Gender Female	0 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 1 month following the procedure

Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.

Outcome measures

Outcome measures
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Stent Migration	0 Participants

PRIMARY outcome

Timeframe: up to one year following the procedure 1 year

Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.

Outcome measures

Outcome measures
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Stent Migration	0 Participants

PRIMARY outcome

Timeframe: up to 1 year following the procedure

Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with \>= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria.

Outcome measures

Outcome measures
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Primary Patency Rate	1 Participants

SECONDARY outcome

Timeframe: up to 1 year following the procedure

Freedom from device-related amputation (amputation of infected limb) is reported as the count of participants with no device-related amputation within 1 year following stent placement.

Outcome measures

Outcome measures
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Freedom From Device-related Amputation	1 Participants

SECONDARY outcome

Timeframe: up to 1 year

Patency refers to whether the stent is unoccluded (open). Primary refers to the first time a stent was placed (or the first time patency needed to be established). Assisted refers to the fact that a device (like a balloon) was used to open the stent. Assisted-primary patency is defined as the count of participants that demonstrated the need for an intervention to establish patency.

Outcome measures

Outcome measures
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Assisted-primary Patency	0 Participants

SECONDARY outcome

Timeframe: up to 1 year

Secondary patency means that the initial intervention failed and a second intervention was performed to establish or maintain patency. Secondary patency is defined as the count of participants that required a second intervention to establish patency.

Outcome measures

Outcome measures
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Secondary Patency	0 Participants

SECONDARY outcome

Timeframe: up to two years 2 years

Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.

Outcome measures

Outcome measures
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Adverse Events	0 Participants

SECONDARY outcome

Timeframe: up to 2 years

The count of participants that experienced a decrease in swelling after the stent was placed.

Outcome measures

Outcome measures
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
Decrease in Swelling of Affected Extremity	0 Participants

SECONDARY outcome

Timeframe: up to 2 years

Population: Data were not collected for this outcome

Venous Clinical Severity represents the severity of the venous pathology, which includes measures like pain, inflammation, and number of ulcers. It is scored on a scale of 0-3 with the upper end representing very severe outcomes for the patient.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

The VEINS-QOL is a questionnaire that represents a patient's quality of life, using measures like how well the patient can walk, sleep, and enjoy life. Responses are graded on a scale of 1-5, with 1 being very good, and 5 being very poor. The VEINS-QOL measure is defined by the count of participants that showed a decreased overall score following their procedure.

Outcome measures

Outcome measures
Measure	Venous Stent Arm n=1 Participants The study is a single treatment arm study and the venous stent will be placed in all eligible participants. Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
VEINS-QOL	1 Participants

SECONDARY outcome

Timeframe: up to 2 years

Population: Data were not collected for this outcome.

The Villalta PTS Scale is a score based on the patient's symptoms, includes cramps, pain, and redness. It is scaled from 0 to 48, with a higher score representing more severe disease.

Outcome measures

Outcome data not reported

Adverse Events

Venous Stent Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rusty Hofmann

Stanford University

Phone: 6507366096

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place