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NCT Number: NCT03320252

Endurant CHevAr New Indication Trial: ENCHANT

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

AAA - Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ordensklinikum Linz GmbH / Elisabethinen, Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endurant Chimney Graft Technique

Device

Medtronic Endurant II and Endurant IIs Stent Graft Systems and balloon-expandable covered stent graft systems approved for use in the renal arteries. These devices will be utilized in a chimney graft configuration.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Official study title

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

Acronym: ENCHANT

Important dates

Study start
2017
Primary completion
2026
Study completion
2030
First posted
Oct 25, 2017
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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