Clinical trial NCT05309707: ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
Official title: ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Aortic Aneurysm
Thoracic Aortic Dissection
Stent-Graft Endoleak
Stent-Graft Stenosis
Intramural Hematoma
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases
Keywords: Aorta
Thoracic aortic aneurysm
Thoracic aorta dissection
Endovascular repair
Lead sponsor: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Sponsor class: NETWORK
First posted: 2022-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with aortic arch pathologies (aneurysm, pseudoanerysm, 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 24 hours
measure: Mortality
timeFrame: 3-6, 12, 24, 36, 48, 60 months
measure: Rupture
timeFrame: 3-6, 12, 24, 36, 48, 60 months
measure: Major Adverse Events (MAE)
timeFrame: prior to discharge, 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Number of interventions
timeFrame: Perioperative
measure: Delivery time
timeFrame: Perioperative
measure: Reintervention
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Endoleak
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Proximal intercomponent separation
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Integrity
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Kinking
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Primary patency
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Secondary patency
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Infection
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Primary technical success
timeFrame: 24 hours
measure: Technical success
timeFrame: 24 hours
measure: Primary clinical success
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Clinical success
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Stable aneurysm size
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Decreasing
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
measure: Increasing
timeFrame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Spanish society for Angiology and Vascular Surgery
Study officials:
References: