Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03743142
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-13
First Post:
2018-10-05
Brief Title:
Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms
Sponsor:
Marc van Sambeek
Organization:
Catharina Ziekenhuis Eindhoven
Study Overview
Official Title:
Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXCeL
Brief Summary:
EVAR continues to evolve as a treatment option for AAA New devices which are specifically designed to perform adequately across the spectrum of potential anatomic presentations for infrarenal EVAR are needed The Department of Vascular Surgery at Catharina Hospital Eindhoven The Netherlands initiates the EXCeL Registry
This study will assess the safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis CEXC Device in patients who meet the IFU anatomic criteria 15mm proximal neck length and 90 proximal neck angulation and 10mm proximal neck length and 60 proximal neck angulation and in patients with challenging anatomic presentation that may present outside the IFU anatomic criteria Successful outcomes from this study will provide evidence to support the CEXC Device as an option for expanding EVAR to a broader patient population with more challenging anatomic presentations
This study will assess the safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis CEXC Device in patients who meet the IFU anatomic criteria 15mm proximal neck length and 90 proximal neck angulation and 10mm proximal neck length and 60 proximal neck angulation and in patients with challenging anatomic presentation that may present outside the IFU anatomic criteria Successful outcomes from this study will provide evidence to support the CEXC Device as an option for expanding EVAR to a broader patient population with more challenging anatomic presentations
Detailed Description:
EXCeL Registry is a multi-center post-market non-interventional non-randomized single-arm prospective observational study initiated by the Department of Vascular Surgery at Catharina Hospital Eindhoven The Netherlands The study has a single-arm without controls as it is descriptive in nature 150 consented subjects from up to 10 high-volume sites across Europe will be included into this registry
Study enrollment is open to consecutively enrolled subjects who in the opinion of the investigator and according to Table A p9 -Anatomic measurement table and group specific- are suitable for being treated An independent core lab will validate pre-requisite anatomy measurement to evaluate candidates for endovascular AAA repair with the GORE EXCLUDER Conformable AAA Endoprosthesis
EXCeL Registry does not intervene with the physicians decision to choose for endovascular treatment with a GORE EXCLUDER Conformable AAA Endoprosthesis Follow-up measurements are requested at 1 month 12 months and yearly thereafter as minimally required by the reporting standards for endovascular aortic aneurysm repair Beyond this sites can schedule the subjects follow-up visits as usual in their clinical practice as this study does not intervene in or influence the follow-up regimen For data completion it is however possible that a telephone-contact with subjects will be requested
This study will assess the safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis in patients who meet the IFU anatomic criteria and in patients with challenging anatomic presentation that may fall outside the IFU anatomic criteria and identified in the protocol as challenging anatomy treatment cohort Consented subjects placed in the challenging anatomy cohort will be followed per the protocol and any data analysis on this cohort will be descriptive in nature only
Up to 11 clinical investigative Sites will enroll a total of 150 subjects to allow for the broad range of aortic necks lengths and aortic neck angulations to be in the study Consecutive consented subjects meeting protocol criteria will be part of the enrollment strategy
Subjects with neck length of 15 mm and neck angulation of 90
Subjects with neck length of 10 mm and neck angulation of 60 An independent Core Lab will read each subjects pre-operative CT images and measure neck length and neck angle These core lab measurements will determine if subjects anatomy meets IFU criteria regarding neck length and neck angle or if this subject has to be placed in the challenging anatomy treatment cohort
The EXCeL Registry by itself has a prospective observational study design and focuses on patients with infrarenal abdominal or aorto-iliac aneurysms with Regular and challenging anatomy scheduled for EVAR treatment with the GORE EXCLUDER Conformable AAA Endoprosthesis No hypotheses testing will be carried out within this study design However the EXCeL Registry aims at creating a database that can analyze the performance of the GORE EXCLUDER Conformable AAA Endoprosthesis in different anatomies
Sample size calculation was precision based in order to achieve a desirable confidence interval width An assumption of freedom from any endpoint event of 90 and a desired Confidence Interval CI of 10 or less results in a sample size of 150 Calculations performed with PASS13
A Subject will be considered lost to follow-up and withdrawn from the study once they have missed two consecutive follow-up visits and three documented attempts have been made by the Investigator or designee to contact the Subject or next of kin In the event that the Subject is lost to follow-up the date of discontinuation of the study will be recorded as the last contact with the Subject by the investigative site
A Subject has completed the study when they have completed the three year follow-up visit Any Subject that does not complete these requirements due to voluntary withdrawal physician withdrawal death or any other reason will be considered a withdrawal
Data collected on each subject will be recorded on an online electronic CRF A paper version of the CRFs may be printed at the sites to use as a working copy Instructions for proper completion of the electronic CRF and how to use it online will be provided to the clinical site The investigator or an authorized member of the investigational team must sign all completed CRFs by using a unique signature code This code will be provided to the user at the start of the study
The Statistics Data Analysis team at the Department of Vascular Surgery Catharina Hospital Eindhoven will check the data entered on the CRFs for consistency and completeness on a regular basis both manually as well as by using statistical monitoring of the clinical database Sites will be contacted for data inconsistencies in order to recover incomplete inconsistent or missing data
In case of multiple futile attempts of data completeness data and non-respond from clinical sites monitors of the Department of Vascular Surgery Catharina Hospital Eindhoven will visit sites They will then collect data from source documents in a final attempt to complete the applicable CRFs To enhance data quality additional site visits may be conducted to crosscheck CRFs with patient files in approximately 20 of enrolled subjects The local investigator will timely be informed of this scheduled visit
Study enrollment is open to consecutively enrolled subjects who in the opinion of the investigator and according to Table A p9 -Anatomic measurement table and group specific- are suitable for being treated An independent core lab will validate pre-requisite anatomy measurement to evaluate candidates for endovascular AAA repair with the GORE EXCLUDER Conformable AAA Endoprosthesis
EXCeL Registry does not intervene with the physicians decision to choose for endovascular treatment with a GORE EXCLUDER Conformable AAA Endoprosthesis Follow-up measurements are requested at 1 month 12 months and yearly thereafter as minimally required by the reporting standards for endovascular aortic aneurysm repair Beyond this sites can schedule the subjects follow-up visits as usual in their clinical practice as this study does not intervene in or influence the follow-up regimen For data completion it is however possible that a telephone-contact with subjects will be requested
This study will assess the safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis in patients who meet the IFU anatomic criteria and in patients with challenging anatomic presentation that may fall outside the IFU anatomic criteria and identified in the protocol as challenging anatomy treatment cohort Consented subjects placed in the challenging anatomy cohort will be followed per the protocol and any data analysis on this cohort will be descriptive in nature only
Up to 11 clinical investigative Sites will enroll a total of 150 subjects to allow for the broad range of aortic necks lengths and aortic neck angulations to be in the study Consecutive consented subjects meeting protocol criteria will be part of the enrollment strategy
Subjects with neck length of 15 mm and neck angulation of 90
Subjects with neck length of 10 mm and neck angulation of 60 An independent Core Lab will read each subjects pre-operative CT images and measure neck length and neck angle These core lab measurements will determine if subjects anatomy meets IFU criteria regarding neck length and neck angle or if this subject has to be placed in the challenging anatomy treatment cohort
The EXCeL Registry by itself has a prospective observational study design and focuses on patients with infrarenal abdominal or aorto-iliac aneurysms with Regular and challenging anatomy scheduled for EVAR treatment with the GORE EXCLUDER Conformable AAA Endoprosthesis No hypotheses testing will be carried out within this study design However the EXCeL Registry aims at creating a database that can analyze the performance of the GORE EXCLUDER Conformable AAA Endoprosthesis in different anatomies
Sample size calculation was precision based in order to achieve a desirable confidence interval width An assumption of freedom from any endpoint event of 90 and a desired Confidence Interval CI of 10 or less results in a sample size of 150 Calculations performed with PASS13
A Subject will be considered lost to follow-up and withdrawn from the study once they have missed two consecutive follow-up visits and three documented attempts have been made by the Investigator or designee to contact the Subject or next of kin In the event that the Subject is lost to follow-up the date of discontinuation of the study will be recorded as the last contact with the Subject by the investigative site
A Subject has completed the study when they have completed the three year follow-up visit Any Subject that does not complete these requirements due to voluntary withdrawal physician withdrawal death or any other reason will be considered a withdrawal
Data collected on each subject will be recorded on an online electronic CRF A paper version of the CRFs may be printed at the sites to use as a working copy Instructions for proper completion of the electronic CRF and how to use it online will be provided to the clinical site The investigator or an authorized member of the investigational team must sign all completed CRFs by using a unique signature code This code will be provided to the user at the start of the study
The Statistics Data Analysis team at the Department of Vascular Surgery Catharina Hospital Eindhoven will check the data entered on the CRFs for consistency and completeness on a regular basis both manually as well as by using statistical monitoring of the clinical database Sites will be contacted for data inconsistencies in order to recover incomplete inconsistent or missing data
In case of multiple futile attempts of data completeness data and non-respond from clinical sites monitors of the Department of Vascular Surgery Catharina Hospital Eindhoven will visit sites They will then collect data from source documents in a final attempt to complete the applicable CRFs To enhance data quality additional site visits may be conducted to crosscheck CRFs with patient files in approximately 20 of enrolled subjects The local investigator will timely be informed of this scheduled visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None