Endurant CHevAr New Indication Trial: ENCHANT (ENCHANT)

May 29, 2026 updated by: Medtronic Cardiovascular

Endurant CHevAr New Indication Trial: ENCHANT - Post-market Study of the Endurant CHEVAR Technique for the Treatment of Juxtarenal Aortic Aneurysms With a Short Infrarenal Neck

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Linz, Austria, 4010
        • Ordensklinikum Linz GmbH / Elisabethinen
  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux - Centre Universitaire Pellegrin
      • Boulogne-Billancourt, France, 92104
        • Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
  • Germany
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz gGmbH
      • Essen, Germany, 45138
        • Elisabeth Krankenhaus Essen GmbH
      • Frankfurt am Main, Germany, 60590
        • Universitäts Klinikum Frankfurt - Goethe-Universität
      • Heidelberg, Germany, 69120
        • UniversitatsKlinikum Heidelberg
      • Münster, Germany, 48145
        • St. Franziskus-Hospital Münster GmbH
  • Greece
      • Athens, Greece, 106 76
        • Evaggelismos General Hospital of Athens
      • Larissa, Greece, 413 34
        • University Hospital Of Larissa
      • Thessaloniki, Greece, 546 42
        • Ippokrateio General Hospital of Thessaloniki
  • Italy
      • Cosenza, Italy, 87100
        • Azienda Ospedaliera di Cosenza
      • La Spezia, Italy, 19124
        • Ospedale Civile Sant'Andrea
      • Roma, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo
  • Netherlands
      • Arnhem, Netherlands, 6815
        • Stichting Rijnstate Ziekenhuis
      • Enschede, Netherlands, 7512 KZ
        • Medisch Spectrum Twente
      • Heerlen, Netherlands, 6419PC
        • Zuyderland Medisch Centrum
  • Portugal
      • Lisbon, Portugal, 1169-024
        • Hospital de Santa Marta
  • Russia
      • Moscow, Russia, 121552
        • Russian Cardiologic Research and Production Complex, Russian Ministry of Health
  • Slovakia
      • Bratislava, Slovakia, 85105
        • CINRE s.r.o.
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Sabadell, Spain, 08208
        • Corporacío Parc Taulí - Hospital de Sabadell
  • Sweden
      • Malmö, Sweden, 205 02
        • Skånes Universitetssjukhus Malmö
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)
  • United Kingdom
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals - NHS Trust
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospitals NHS - Manchester Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be comprised of subjects that meet the indications for the Endurant Chimney Graft Technique for the endovascular treatment of juxtarenal aortic aneurysms with a short infrarenal neck.

Description

Inclusion Criteria:

  • Subject is ≥18 years old
  • Subject is scheduled for primary treatment of the juxtarenal aortic aneurysm with a short infrarenal neck (i.e. no revision subjects)
  • Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
  • Subject has provided written informed consent
  • Subject is an eligible candidate according to the currently available Endurant II/IIs instructions for use for ChEVAR
  • Subject has a juxtarenal aortic aneurysm with a short infrarenal neck (definition of juxtarenal aortic aneurysm with a short infrarenal neck will be in accordance with commercially available Endurant II/IIs instructions for use for ChEVAR).

Exclusion Criteria:

  • Subject is participating in a concurrent study which may confound study results
  • Subject has a life expectancy ≤ 2 year

  • Subject has an aneurysm that is:

    • Suprarenal or pararenal
    • Isolated iliofemoral
    • Mycotic
    • Inflammatory
    • Pseudoaneurysm
  • Subject requires emergent aneurysm treatment, for example, trauma or rupture
  • Subject has previously undergone surgical treatment for abdominal aortic aneurysm
  • Subject is a female of childbearing potential in whom pregnancy cannot be excluded
  • Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
  • Subject has a creatinine level >2.0 mg/dl (or >176.8 μmol/L) and/or is on dialysis
  • Subject has an active COVID-19 infection or relevant history of COVID-19. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 6 months prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary safety endpoint evaluated by proportion of subjects experiencing a Major Adverse Event through 30 days post-index procedure
Time Frame: through 30 days post-index procedure

Major Adverse Events include the occurrence of any of the following events:

  • All-cause mortality
  • Bowel ischemia
  • Myocardial infarction
  • Paraplegia
  • Procedural blood loss ≥1000 cc
  • Renal failure
  • Respiratory failure
  • Stroke
through 30 days post-index procedure
The primary performance endpoint is defined as the proportion of subjects who have technical success at the time of the index procedure and are free from secondary interventions through 365 days.
Time Frame: Index procedure and through 365 days
Index procedure and through 365 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Succes
Time Frame: Index procedure and within 30-days post-index procedure
Technical success and freedom from intra-operative death and freedom from type Ia/III endoleak in the first image within 30-days post-index procedure
Index procedure and within 30-days post-index procedure
Secondary safety endpoints
Time Frame: through 30 days and annually up to 5 year follow up
  • Aneurysm rupture
  • Conversion to open surgery
  • Aneurysm related mortality
  • All-cause mortality
  • MAEs through 365 days
through 30 days and annually up to 5 year follow up
Secondary imaging based endpoints
Time Frame: at 30 days and at annual follow-up until 60 months post-index procedure
  • Stent graft fractures (endograft, chimney graft)
  • Stent graft occlusion (endograft, chimney graft)
  • Endoleak of all types
  • Stent graft migration >10 mm (endograft)
  • Aneurysm sac expansion ≥ 5 mm
at 30 days and at annual follow-up until 60 months post-index procedure
Change in renal function
Time Frame: at 30 days and at annual follow-up until 60 months post-index procedure
Change in renal function compared to baseline
at 30 days and at annual follow-up until 60 months post-index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT16022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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