Trial Outcomes & Findings for Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures (NCT NCT01343160)

Results Overview

The stent removal is considered safe when the Study Device is removed successfully and without SAEs.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

Upon Removal

Results posted on

2021-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	GORE VIABIL® Biliary Endoprosthesis Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency GORE® VIABIL® Biliary Endoprosthesis: Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture
Overall Study STARTED	36
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GORE VIABIL n=36 Participants GORE® VIABIL® Biliary Endoprosthesis
Age, Continuous	57.9 Years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	07 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment Germany	33 participants n=5 Participants
Region of Enrollment Belgium	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Upon Removal

Population: Subjects with stent removal data available

The stent removal is considered safe when the Study Device is removed successfully and without SAEs.

Outcome measures

Outcome measures
Measure	GORE VIABIL n=33 Participants GORE® VIABIL® Biliary Endoprosthesis
Safe Stent Removal	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Primary device patency is defined as the freedom from device occlusion requiring intervention (during the treatment period).

Outcome measures

Outcome measures
Measure	GORE VIABIL n=36 Participants GORE® VIABIL® Biliary Endoprosthesis
Primary Device Patency	77.7 percentage of participants Interval 55.9 to 89.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Upon Implant

This requires successful delivery and deployment of the device at the intended site.

Outcome measures

Outcome measures
Measure	GORE VIABIL n=36 Participants GORE® VIABIL® Biliary Endoprosthesis
Successful Delivery and Deployment	36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Upon implant

Successful treatment of strictures is defined as stricture resolution upon implant as reported by the PI. For the purpose of this report, we will be referring to this as "stented stricture resolution".

Outcome measures

Outcome measures
Measure	GORE VIABIL n=36 Participants GORE® VIABIL® Biliary Endoprosthesis
Successful Treatment of Benign Stricture Upon Implant	35 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Outcome measures

Outcome measures
Measure	GORE VIABIL n=36 Participants GORE® VIABIL® Biliary Endoprosthesis
Secondary Patency	84.3 percentage of participants Interval 62.5 to 93.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Upon Removal

Population: Subjects with stent removal data available

Treatment is considered viable when the Study Device is removed and the structure is either resolved or improved without the need for re-stenting at the time of Study Device removal.

Outcome measures

Outcome measures
Measure	GORE VIABIL n=32 Participants GORE® VIABIL® Biliary Endoprosthesis
Viability of Treatment	26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 Months

Secondary patency post study device removal is defined as the absence of stricture recurrence from time of Study Device removal to study completion or lost to follow up. Secondary Patency is also known as Long Term Stricture Resolution.

Outcome measures

Outcome measures
Measure	GORE VIABIL n=33 Participants GORE® VIABIL® Biliary Endoprosthesis
Secondary Patency Post Study Device Removal	67.8 percentage of participants Interval 48.0 to 81.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 Months

Primary patency of the treated stricture is defined as freedom from stricture intervention due to occlusion following Study Device removal.

Outcome measures

Outcome measures
Measure	GORE VIABIL n=33 Participants GORE® VIABIL® Biliary Endoprosthesis
Primary Patency of Treated Stricture	64.8 percentage of participants Interval 45.2 to 78.9

Adverse Events

GORE VIABIL

Serious events: 19 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	GORE VIABIL n=36 participants at risk GORE® VIABIL® Biliary Endoprosthesis
Hepatobiliary disorders Recurrence of obstructive jaundice	13.9% 5/36 • Number of events 5 • Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post stent removal
Hepatobiliary disorders Pancreatitis	5.6% 2/36 • Number of events 2 • Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post stent removal
Hepatobiliary disorders Cholecystitis	5.6% 2/36 • Number of events 2 • Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post stent removal
Hepatobiliary disorders Papillary hemorrhage	2.8% 1/36 • Number of events 1 • Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post stent removal
Hepatobiliary disorders Cholangitis	11.1% 4/36 • Number of events 4 • Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post stent removal
General disorders Other	22.2% 8/36 • Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post stent removal

Other adverse events

Other adverse events
Measure	GORE VIABIL n=36 participants at risk GORE® VIABIL® Biliary Endoprosthesis
General disorders Other	16.7% 6/36 • Adverse events were collected for patients upto 12 Months of treatment period with the stent and upto 15 Months of post stent removal

Additional Information

Rizwan Afzal

W.L. Gore & Associates

Phone: 623-234-5408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. Sponsor can require changes to the communication as necessary to ensure the proper use of any references to itself, its trademarks, and trade names and to correct inaccuracies in any technical specifications or descriptions of the device, including its component materials.
Publication restrictions are in place

Restriction type: OTHER