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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743142
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Marc van Sambeek, Catharina Ziekenhuis Eindhoven

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.


Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm (AAA) Procedure: endovascular repair of the AAA

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Primary safety success defined by the absence of major adverse events [ Time Frame: up to 30 days after index procedure ]
    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).

  2. Technical treatment success [ Time Frame: At the primary procedure ]
    Proportion of subjects who experience successful, delivery and deployment of all required EXCC Device components annd successful removal of EXCC device delivery catheter(s)

  3. Clinical effectiveness success [ Time Frame: 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 ]
    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


Secondary Outcome Measures :
  1. Incidence of treatment-emerged adverse events (safety) [ Time Frame: From hospital admission before index procedure up to study completion after the 3 years follow up ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with AAA are eligible for participation and study screening.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743142


Contacts
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Contact: Jenny Zwetsloot, MSc +31 (0)40 239 6349 jenny.zwetsloot@catharinaziekenhuis.nl

Locations
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France
APHP Hopital Européen Recruiting
Paris, France
Contact: Jean-Marc Alsac         
Principal Investigator: Alsac         
Germany
Klinikum Darmstadt Not yet recruiting
Darmstadt, Germany
Contact: Farzin Adili         
Principal Investigator: Adili         
Niels Stensen Kliniken Not yet recruiting
Osnabrück, Germany
Contact: Jorg Heckenkamp         
Principal Investigator: Heckenkamp         
Italy
Sant'Orsola Hospital Withdrawn
Bologna, Italy
San Martino Hospital Recruiting
Genova, Italy
Contact: Giovanni Pratesi         
Principal Investigator: Pratesi         
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Netherlands
Contact: Michelle Simons         
Principal Investigator: Reijnen         
Catharina Hospital Recruiting
Eindhoven, Netherlands, 5623EJ
Contact: Jenny Zwetsloot, MSc    +31 (0)40 239 6349    jenny.zwetsloot@catharinaziekenhuis.nl   
Principal Investigator: van Sambeek         
Spain
San Carlos Hospital Recruiting
Madrid, Spain
Contact: Javier Serrano         
Principal Investigator: Serrano         
Complexo Hospitalario de Orense Recruiting
Orense, Spain
Contact: Nilo Mosquera         
Principal Investigator: Mosquera         
United Kingdom
Blefast health and Social Care Trust Not yet recruiting
Belfast, United Kingdom
Contact: Louis Lau         
Principal Investigator: Lau         
North Bristol NHS Trust Recruiting
Bristol, United Kingdom
Contact: Marcus Brooks         
Principal Investigator: Brooks         
Sponsors and Collaborators
Marc van Sambeek
Investigators
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Principal Investigator: M.R.H.M. van Sambeek, Prof. dr. Catharina Ziekenhuis Eindhoven
Additional Information:

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Responsible Party: Marc van Sambeek, prof. dr. M.R.H.M. van Sambeek, vascular surgeon, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT03743142    
Other Study ID Numbers: EXCeL
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases