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

NCT03743142 | Active Not Recruiting

• 1 other identifier: EXCeL
• Study Type: observational
• Target: 156
• Locations: 5 countries
• Sites: 8

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.

Conditions

Abdominal Aortic Aneurysm (AAA)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Incidence of treatment-emerged adverse events (safety)

  From hospital admission before index procedure up to study completion after the 3 years follow up

Study Arms (1)

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

Interventions

endovascular repair of the AAA PROCEDURE

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.

Patients with AAA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AAA are eligible for participation and study screening.

You may qualify if:

• \. 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

You may not qualify if:

• Mycotic or ruptured aneurysm
• 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
• \. 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

Sponsors & Collaborators

• Marc van Sambeek: lead

Study Sites (8)

APHP Hopital Européen

Paris, France

Location

San Martino Hospital

Genova, Italy

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Catharina Hospital

Eindhoven, 5623EJ, Netherlands

Location

ETZ

Tilburg, Netherlands

Location

San Carlos Hospital

Madrid, Spain

Location

Complexo Hospitalario de Orense

Ourense, Spain

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• M.R.H.M. van Sambeek, Prof. dr.

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: prof. dr. M.R.H.M. van Sambeek, vascular surgeon

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: November 16, 2018
• Study Start: September 11, 2018
• Primary Completion: September 30, 2025
• Study Completion: January 31, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

ES (2); IT (1); FR (1); NL (3); GB (1)