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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Thoracic Aortic Aneurysm; Thoracic Aortic Dissection; Intramural Hematoma; Stent-Graft Endoleak; Stent-Graft Stenosis
• Intervention / Treatment: Device: Endovascular exclusion

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Recruiting
    • Spanish society for Angiology and Vascular Surgery
    • Contact: Enrique M San Norberto, MD, PhD, MsC, PGCert; Phone Number: 86962 00346983420000; Email: esannorberto@hotmail.com
    • Sub-Investigator: Manuel Alonso Pérez, MD, PhD
    • Sub-Investigator: Diego Caicedo Valdés, MD
    • Sub-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
    • Principal Investigator: Guido Volo Perez, MD
    • Principal Investigator: Enrique M San Norberto García, MD, PhD, MSc, PGCert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with aortic arch pathologies treated by branch stent graft systems; Patients with aortic arch pathologies treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.	Device: Endovascular exclusion; Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality in peri-operative periods (all related interventions)	24 hours
Technical success	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.	24 hours
Mortality	Rate of all-cause mortality	3-6, 12, 24, 36, 48, 60 months
Rupture	Rate of patients with aneurysm rupture	3-6, 12, 24, 36, 48, 60 months
Major Adverse Events (MAE)	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)	prior to discharge, 30 days, 3-6, 12, 24, 36, 48, 60 months
Number of interventions	Rate of interventions in peri-operative periods (all related interventions until index procedure)	Perioperative
Delivery time	Rate of time intervals the branched-stent graft implantation	Perioperative
Reintervention	Rate of reinterventions	30 days, 3-6, 12, 24, 36, 48, 60 months
Endoleak	Rate of patients with endoleak	30 days, 3-6, 12, 24, 36, 48, 60 months
Proximal intercomponent separation	Rate of patients with intercomponent separation at the proximal end of the Nexus stent-graft system > 10 mm	30 days, 3-6, 12, 24, 36, 48, 60 months
Integrity	Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break)	30 days, 3-6, 12, 24, 36, 48, 60 months
Kinking	Rate of patients with stent graft or bridging stent graft kinking	30 days, 3-6, 12, 24, 36, 48, 60 months
Primary patency	Rate of primary patency of bridging stents	30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary patency	Rate of secondary patency of bridging stents	30 days, 3-6, 12, 24, 36, 48, 60 months
Infection	Rate of patients with stent graft infection	30 days, 3-6, 12, 24, 36, 48, 60 months
Primary technical success	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	24 hours
Primary clinical success	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	30 days, 3-6, 12, 24, 36, 48, 60 months
Clinical success	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.	30 days, 3-6, 12, 24, 36, 48, 60 months
Stable aneurysm size	Rate of patients with stable aneurysm size	30 days, 3-6, 12, 24, 36, 48, 60 months
Decreasing	Rate of patients with decreasing (<5mm) aneurysm size	30 days, 3-6, 12, 24, 36, 48, 60 months
Increasing	Rate of patients with increasing (>5mm) aneurysm size	30 days, 3-6, 12, 24, 36, 48, 60 months

Collaborators and Investigators

• Sponsor: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Publications and helpful links

Helpful Links

• Spanish Society for Angiology and Vascular Surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): December 31, 2027

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (ACTUAL): April 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Endovascular repair; Aorta; Thoracic aortic aneurysm; Thoracic aorta dissection
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage; Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Hematoma; Aortic Diseases; Endoleak
• Other Study ID Numbers: 2022-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data analyzed by core lab

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No