Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms (EXCeL)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Abdominal Aortic Aneurysm (AAA)
• Intervention / Treatment: Procedure: endovascular repair of the AAA

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 (p.9) -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 physician's 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 subject's 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 subject's 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 Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

• Study Contact: Name: Jenny Zwetsloot, MSc; Phone Number: +31 (0)40 239 6349; Email: jenny.zwetsloot@catharinaziekenhuis.nl

Study Locations

• France
  • Paris, France
    • APHP Hopital Européen
• Italy
  • Genova, Italy
    • San Martino Hospital
• Netherlands
  • Arnhem, Netherlands
    • Rijnstate Hospital
  • Eindhoven, Netherlands, 5623EJ
    • Catharina Hospital
  • Tilburg, Netherlands
    • ETZ
• Spain
  • Madrid, Spain
    • San Carlos Hospital
  • Orense, Spain
    • Complexo Hospitalario de Orense
• United Kingdom
  • Bristol, United Kingdom
    • North Bristol NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with AAA are eligible for participation and study screening.

Description

Inclusion Criteria:

1. AAA meeting any of the following criteria:

• Maximum diameter ≥50 mm
• Rapid growth (>5 mm in a 6 month period)
• Non-ruptured AAA presenting with clinical symptoms 2 Adequate anatomy to receive the CEXC Device, including:
• Adequate iliac / femoral access
• Infrarenal aortic neck diameter 16-32 mm
• Distal iliac artery seal zone ≥10 mm
• Iliac artery diameter 8-25 mm 3. An Informed Consent Form (ICF) dated and signed by subject 4. Male or infertile female* 5. Able to comply with protocol requirements including following-up 6. Life expectancy >2 years 7. Age ≥18 years * Infertile female - condition which prevents pregnancy, e.g., hysterectomy, tubal ligation or post-menopausal for greater than 1 year

Exclusion Criteria:

1. Mycotic or ruptured aneurysm
2. Saccular aneurysm, unless it meets inclusion criteria of rapid growth (>5 mm in a 6 month period) or maximum diameter of (≥50 mm)
3. Known concomitant thoracic aortic aneurysm which requires surgical intervention 4. Renal insufficiency defined as creatinine >2.5 mg/dL or GFR <30 mL/min/1.73 m2

5. Patient has body habitus or other medical condition which prevents adequate delineation of the aorta 6. Participating in another investigational device study within 1 year of treatment 7. Systemic infection which may increase the risk of endovascular graft infection 8. Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome 9. Planned concomitant surgical procedure or major surgery within 30 days of treatment date, including planned branched, snorkel or chimney procedures 10. Known sensitivities or allergies to the device materials 11. Use of non-Gore stent grafts in initial procedure

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with AAA; Patients with AAA are eligible for participation and study screening. They will receive, once included, an endovascular repair of the AAA	Procedure: endovascular repair of the AAA; The Investigator will ensure that investigational devices are used only in subjects properly enrolled in the clinical study in accordance with the protocol. Subjects will undergo endovascular repair of their AAA. Procedural details may vary between sites, but will follow standard hospital protocol for EVAR and patient care management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety success defined by the absence of major adverse events	These major adverse events are defined as all-cause mortality, stroke, mycardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure and thromboembolic events (including limb occlusion and distal embolic events).	up to 30 days after index procedure
Technical treatment success	Proportion of subjects who experience successful, delivery and deployment of all required EXCC Device components annd successful removal of EXCC device delivery catheter(s)	At the primary procedure
Clinical effectiveness success	Effectiveness defined as absence of type I endoleak at each visit, Type III endoleak at the 12 month visit, migration (10 mm or more) between the one month and the 12 month visit, AAA enlargement >5 mm with or without intervention between the one month and the 12 month visit, AAA rupture through the 12 month visit, conversion to open repair through the 12 month visit, limb occlusion	From the day after the initial procedure up to 3 years after the initial procedure (which is the end of the follow up period for this registry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emerged adverse events (safety)	30 day major adverse events, individual elements of the primary safety and effectiveness endpoints, secondary procedures, type II endoleak, type IV endoleak, index procedure blood loss, index procedure time, length of hospital stay	From hospital admission before index procedure up to study completion after the 3 years follow up

Collaborators and Investigators

• Sponsor: Marc van Sambeek
• Investigators: Principal Investigator: M.R.H.M. van Sambeek, Prof. dr., Catharina Ziekenhuis Eindhoven

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: EXCeL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

All records and other information about subjects participating in this registry will be treated as confidential. The sponsor, Department of Vascular Surgery, Catharina Hospital, Eindhoven, will collect data and monitors study records.Study data may be made available to third parties, e.g., in the case of an audit performed by regulatory authorities, provided the data are treated confidentially and that the subject's privacy is guaranteed.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No