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NCT Number: NCT05309707

ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"

The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

The secondary objective is to evaluate the safety and clinical performance of the studied devices.

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Key information

Conditions

Thoracic Aortic Aneurysm Acute Aortic Syndrome Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Dissection, Thoracic Aorta Intramural Hematoma Stent-Graft Endoleak Stent-Graft Stenosis Thoracic Aortic Dissection Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spanish society for Angiology and Vascular Surgery

Madrid, 28006, Spain

Location status: Recruiting

Location contact

Diego Caicedo Valdés, MD

SUB_INVESTIGATOR

Enrique M San Norberto García, MD, PhD, MSc, PGCert

PRINCIPAL_INVESTIGATOR

Enrique M San Norberto, MD, PhD, MsC, PGCert

CONTACT

[email protected]

00346983420000 ext. 86962

Guido Volo Perez, MD

PRINCIPAL_INVESTIGATOR

Ivan Constenla García, MD

SUB_INVESTIGATOR

Jaume Dilme Muñoz, MD

SUB_INVESTIGATOR

Jorge Fernández Noya, MD

SUB_INVESTIGATOR

José M Ligero Ramos, MD, PhD

SUB_INVESTIGATOR

Luis Salmerón Febres, MD, PhD

SUB_INVESTIGATOR

Manuel Alonso Pérez, MD, PhD

SUB_INVESTIGATOR

About this study

In this study patients will be observed, who receive a branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) for the endovascular treatment of aortic arch pathologies with proximal landing at zone 0. The devices will be implanted at the discretion of the treating physician.

Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the branch stent graft systems for aortic arch (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®). Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.

The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is between 18 and 90 years old
  • Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0.
  • Patient must be available for the appropriate follow-up times for the duration of the study
  • Informed consent signed.

Exclusion criteria

  • Patient less than 18 years old or more than 90 years old.
  • Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium)
  • Patient has systemic infection or suspected systemic infection
  • Patient has thrombocytopenia (platelet count < 150000/µl)
  • Patient has untreated hyperthyroidism
  • Patient has a progressive or untreated malignancy.
  • Patient is pregnant or breastfeeding.
  • Patient has a life expectancy of less than 1 year.
  • Not informed consent signed

Treatment and study plan

Endovascular exclusion

Device

Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

Primary outcomes

  1. Mortality

    Time frame: 30 days

    Rate of all-cause mortality

Secondary outcomes

  1. Mortality

    Time frame: 24 hours

    Rate of all-cause mortality in peri-operative periods (all related interventions)

  2. Mortality

    Time frame: 3-6, 12, 24, 36, 48, 60 months

    Rate of all-cause mortality

  3. Rupture

    Time frame: 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with aneurysm rupture

  4. Major Adverse Events (MAE)

    Time frame: prior to discharge, 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with major adverse events (aneurysm related death, aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke, visceral ischemia (bowel ischemia with surgery or submission to ICU or bowel necrosis with surgery or submission to ICU), new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, new permanent paraplegia, new permanent paraparesis, lower limb ischemia (increase in Rutherford classification) (product-related, procedure-related, aneurysm-related)

  5. Number of interventions

    Time frame: Perioperative

    Rate of interventions in peri-operative periods (all related interventions until index procedure)

  6. Delivery time

    Time frame: Perioperative

    Rate of time intervals the branched-stent graft implantation

  7. Reintervention

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of reinterventions

  8. Endoleak

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with endoleak

  9. Proximal intercomponent separation

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with intercomponent separation at the proximal end of the Nexus stent-graft system > 10 mm

  10. Integrity

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break)

  11. Kinking

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with stent graft or bridging stent graft kinking

  12. Primary patency

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of primary patency of bridging stents

  13. Secondary patency

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of secondary patency of bridging stents

  14. Infection

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with stent graft infection

  15. Primary technical success

    Time frame: 24 hours

    Rate of patients with primary technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated within 24 h after the index procedure.

    Successful introduction and deployment of the multibranch stent-graft systems in the absence of:

    Surgical conversion Mortality Reintervention Unplanned branch vessel occlusion (post-operative occlusion)

    Including:

    Secure proximal and distal fixation Patent treated branch vessels

  16. Technical success

    Time frame: 24 hours

    Rate of patients with technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure.

  17. Primary clinical success

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with primary clinical success.

    Primary clinical success is reported on an intent-to-treat basis and is reached if the following criteria are fulfilled at the time of follow-up starting at 12 months follow-up:

    Successful deployment of the endovascular devices at the intended location in the absence of:

    Death as result of aneurysm-related treatment Conversion to open repair Reintervention after index procedure Occlusion of treated branch vessels Type I or III endoleak Increasing aneurysm size Aneurysm rupture

  18. Clinical success

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with clinical success. Clinical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure.

  19. Stable aneurysm size

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with stable aneurysm size

  20. Decreasing

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with decreasing (<5mm) aneurysm size

  21. Increasing

    Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months

    Rate of patients with increasing (>5mm) aneurysm size

Sponsors and collaborators

Lead sponsor

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Network

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Apr 4, 2022
Registry last updated
Apr 4, 2022

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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