AXIOS Stent & Delivery System Study

A Prospective, Multi-center, Non-blinded, Single-arm (Nonrandomized) Study of the AXIOS Stent and Delivery System

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01419769

Enrollment

Registered

2011-08-18

Start date

2011-08-31

Completion date

2013-04-30

Last updated

2015-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Pseudocyst(s)

Keywords

symptomatic pancreatic pseudocyst, pancreatic pseudocyst, transluminal drainage, minimally invasive, Nitinol stent, transmural endoscopic drainage, catheter based

Brief summary

The Xlumena AXIOS Stent and Delivery System is an investigational device in the USA, and this study is being conducted under an Investigational Device Exemption (IDE) granted by the US Food and Drug Administration (FDA). The study design is prospective, multi-center, non-blinded, single-arm (nonrandomized) study. Up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States. Patients will be followed at (approximately) 30 days and/or 60 days depending upon pseudocyst resolution confirmation, at 1-week post-stent removal,and possibly at 3 and 6 month post-stent removal.

Detailed description

OBJECTIVE: To demonstrate the safety and effectiveness of the Xlumena AXIOS Stent and Delivery System for endoscopic drainage of pancreatic pseudocysts in patients with symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm (≥6cm) in diameter, have ≥ 70% fluid contents and are adherent to the bowel wall. STUDY DESIGN: Prospective, multi-center, non-blinded, single-arm (nonrandomized) study KEY ENDPOINTS: Safety: The safety endpoint is freedom from major complications through the duration of the 1-week post-stent removal study period, defined as: 1. Access site-related bleeding requiring transfusion; 2. Access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization; 3. Surgery for access-site related perforation; 4. Stent migration/dislodgement into the pseudocyst or enteral lumen; 5. Tissue injury, defined as ulceration to the submucosa at site of stent implant as observed to persist through 1-week post-stent removal. 6. Serious adverse event classified as implant-associated or implant/endoscopic procedure-associated; Effectiveness: 1. Stent lumen patency at 30 days and/or 60 days 2. Stent removability at 30 days and/ or 60 days. 3. Technical success, defined as: placement of the AXIOS stent using the AXIOS delivery system and removal of the AXIOS stent using a standard endoscopic snare. 4. Clinical success, defined as: at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days. PATIENT POPULATION: Patients between 18 and 75 years of age, suitable for transluminal drainage of symptomatic pancreatic pseudocysts that are greater than or equal to 6 cm in diameter and adherent to the bowel wall are candidates for study treatment. FOLLOW-UP SCHEDULE: Clinical follow-up evaluations of study endpoints will be conducted at 30 days and/or 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal. PLANNED NUMBER OF PATIENTS, SITES & REGIONS: The target enrollment for the study is 24 subjects. Study will be conducted at up to 10 investigational sites in the United States, Japan and/or the European Community. A majority of the patients will be enrolled in the United States.

Interventions

DEVICEAXIOS Stent & Delivery System

The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States. Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates. Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* (patients must meet all criteria) 1. Age between 18 and 75 years old, male or female. 2. Eligible for endoscopic intervention. 3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage 4. Symptomatic pancreatic pseudocyst having the following characteristics: * Greater than or equal to 6 cm in size (based upon the maximum crosssectional area in the CT scan), * Adherent to bowel wall, and * ≥70% fluid content 5. Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed. 6. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.

Exclusion criteria

* (patients meeting any of the below criteria will be excluded from study) 1. \<18 or \>75 years of age 2. Pancreatic pseudocysts having the following characteristics: * Require nasocystic drainage, * \< 69% fluid content 3. The fluid collection to be drained is an immature pseudocyst 4. The fluid collection to be drained is a cystic neoplasm 5. The fluid collection to be drained is a pseudoaneurysm 6. The fluid collection to be drained is a duplication cyst 7. The fluid collection to be drained is a non-inflammatory fluid collection 8. There is more than one pseudocyst requiring drainage 9. Abnormal coagulation: * INR \> 1.5 and not correctable * presence of a bleeding disorder * platelets \< 50,000/mm3 10. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis). 11. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound) 12. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient. 13. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study. 14. Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Design outcomes

Primary

Measure	Time frame	Description
Safety - Freedom From Major Complications: SAE's	Through the duration of the 1-week post-stent removal study period	Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.
Safety - Freedom From Major Complications: Access Site-related Infection	Through the duration of the 1-week post-stent removal study period	Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization
Safety - Freedom From Major Complications: Perforation	Through the duration of the 1-week post-stent removal study period	Subjects are free of surgery for access-site related perforation
Safety - Freedom From Major Complications: Stent Migration/Dislodement	Through the duration of the 1-week post-stent removal study period	Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen
Safety - Freedom From Major Complications: Tissue Injury	Through the duration of the 1-week post-stent removal study period	Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.
Safety - Freedom From Major Complications: Access Site-related Bleeding	Through the duration of the 1-week post-stent removal study period	Subjects are free of access site-related bleeding requiring transfusion

Secondary

Measure	Time frame	Description
Effectiveness: Stent Removability at 30 Days and/or 60 Days	Up to 60 days	AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.
Effectiveness: Technical Success	Up to 60 days	Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.
Clinical Success	Up to 60 days	Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.
Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days	Up to 60 days	Stent lumen patency at 30 days and/or 60 days.

Countries

Spain, United States

Participant flow

Participants by arm

Arm	Count
AXIOS Stent and Delivery System AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States. Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates. Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.	33
Total	33

Arm

Count

AXIOS Stent and Delivery System

AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States. Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates. Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Did not receive the AXIOS stent	3
Overall Study	Not evaluable due to pigtail stents	1

Baseline characteristics

Characteristic	AXIOS Stent and Delivery System
Age, Continuous	52.6 Years STANDARD_DEVIATION 14
Height	67.4 inches STANDARD_DEVIATION 3.9
Region of Enrollment Spain	3 participants
Region of Enrollment United States	30 participants
Sex: Female, Male Female	15 Participants
Sex: Female, Male Male	18 Participants
Weight	169.5 pounds STANDARD_DEVIATION 43.5

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	15 / 33
serious Total, serious adverse events	16 / 33