Trial Outcomes & Findings for AXIOS Stent With Electrocautery Enhanced Delivery System (NCT NCT02146352)

NCT ID: NCT02146352

Last Updated: 2015-10-02

Results Overview

Freedom from access site-related bleeding requiring transfusion

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Index procedure through 1-week post-stent removal

Results posted on

2015-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Overall Study STARTED	30
Overall Study 30 or 60 Days Post-procedure	30
Overall Study 7 Days Post-stent Removal	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Overall Study Death	1
Overall Study Patient entered hospice care	1

Baseline Characteristics

AXIOS Stent With Electrocautery Enhanced Delivery System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=30 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Age, Continuous	52.0 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Height	67.3 inches STANDARD_DEVIATION 4.3 • n=5 Participants
Weight	172.9 pounds STANDARD_DEVIATION 36.8 • n=5 Participants

PRIMARY outcome

Timeframe: Index procedure through 1-week post-stent removal

Population: Entire patient cohort

Freedom from access site-related bleeding requiring transfusion

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Safety/Adverse Event Outcome Measure 1	100 percentage of patients

PRIMARY outcome

Timeframe: Index procedure through 1-week post-stent removal

Population: Entire patient cohort

Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Safety/Adverse Event Outcome Measure 2	100 percentage of patients

PRIMARY outcome

Timeframe: Index procedure through 1-week post-stent removal

Population: Entire patient cohort

Freedom from surgery for access-site related perforation

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Safety/Adverse Event Outcome Measure 3	100 percentage of patients

PRIMARY outcome

Timeframe: Index procedure through 1-week post-stent removal

Population: Patients for which AXIOS stent migration/dislodgement could be assessed

Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Safety/Adverse Event Outcome 4	96.4 percentage of patients

PRIMARY outcome

Timeframe: Index procedure through 1-week post-stent removal

Population: Patients for which AXIOS stent was removed and tissue at site of stent implant was observed at time of removal

Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Safety/Adverse Event Outcome Measure 5	100 percentage of patients

PRIMARY outcome

Timeframe: Index procedure through 1-week post-stent removal

Population: Entire patient cohort

Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Safety/Adverse Event Outcome Measure 6	93.3 percentage of patients

SECONDARY outcome

Timeframe: 30 or 60 days post-procedure

Population: Per Protocol Population

Stent Retention: The stent must remain in place for up to 60 days

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Stent Retention Outcome Measure	100 percentage of patients

SECONDARY outcome

Timeframe: 30 and/or 60 days post-procedure

Population: Per Protocol

Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Lumen Patency Outcome Measure	86.7 percentage of patients

SECONDARY outcome

Timeframe: Index Procedure

Population: Per Protocol

Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Technical Success Outcome Measure 1	100 percentage of patients

SECONDARY outcome

Timeframe: 30 or 60 days post-procedure

Population: Entire patient cohort

Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Clinical Success Outcome Measure	83.3 percentage of patients

SECONDARY outcome

Timeframe: 30 or 60 Day Post-procedure

Population: Per Protocol

Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps

Outcome measures

Outcome measures
Measure	Treatment n=27 Participants AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Technical Success Outcome Measure 2	100 percentage of patients

Adverse Events

Treatment

Serious events: 13 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=30 participants at risk AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Gastrointestinal disorders Pancreatitis	30.0% 9/30 • Number of events 10 • Index procedure through 1-week post-stent removal
Infections and infestations Bronchitis	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Hepatobiliary disorders Biliary Stricture	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Surgical and medical procedures Bleeding post-AXIOS stent removal	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Infections and infestations Cellulitis	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Infections and infestations Sepsis	3.3% 1/30 • Number of events 2 • Index procedure through 1-week post-stent removal
Cardiac disorders Chest pain/shortness of breath	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal

Other adverse events

Other adverse events
Measure	Treatment n=30 participants at risk AXIOS Stent with Electrocautery Enhanced Delivery System AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Gastrointestinal disorders Abdominal Pain	10.0% 3/30 • Number of events 3 • Index procedure through 1-week post-stent removal
Gastrointestinal disorders Ascites	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Surgical and medical procedures Bleeding post-AXIOS stent removal	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Renal and urinary disorders Blood in urine	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Cardiac disorders Chest pain	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Injury, poisoning and procedural complications Concussion	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Infections and infestations Fever	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
General disorders Lightheadedness/ dizziness	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Gastrointestinal disorders Nausea	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Endocrine disorders Pancreatic duct leak	6.7% 2/30 • Number of events 2 • Index procedure through 1-week post-stent removal
Skin and subcutaneous tissue disorders Rash	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Gastrointestinal disorders Spontaneous stent migration	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Gastrointestinal disorders Ulceration	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal
Gastrointestinal disorders Weight loss	3.3% 1/30 • Number of events 1 • Index procedure through 1-week post-stent removal

Additional Information

Lina Ginnetti

Boston Scientific Corp.

Phone: 508-683-4512

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI must wait 9 months after close of study for Sponsor to present collaborative publication. If Sponsor does not publish within 9 months after close of study, PI may publish institution's results at that time. Sponsor can review results prior to public release and embargo communications on trial results for a period that is more than 60 days but less than or equal to 6 months from the date the PI gets the objection. The Sponsor cannot require changes to the communication nor extend the embargo.
Publication restrictions are in place

Restriction type: OTHER