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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309707
• Other study ID #: 2022-03
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2022
• Source: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Diseases
• Cardiovascular Diseases
• Endoleak
• Hematoma
• Intramural Hematoma
• Stent-Graft Endoleak
• Thoracic Aortic Aneurysm
• Thoracic Aortic Dissection
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Spain	Spanish society for Angiology and Vascular Surgery	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Rate of all-cause mortality	30 days
Secondary	Mortality	Rate of all-cause mortality in peri-operative periods (all related interventions)	24 hours
Secondary	Mortality	Rate of all-cause mortality	3-6, 12, 24, 36, 48, 60 months
Secondary	Rupture	Rate of patients with aneurysm rupture	3-6, 12, 24, 36, 48, 60 months
Secondary	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
Secondary	Number of interventions	Rate of interventions in peri-operative periods (all related interventions until index procedure)	Perioperative
Secondary	Delivery time	Rate of time intervals the branched-stent graft implantation	Perioperative
Secondary	Reintervention	Rate of reinterventions	30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary	Endoleak	Rate of patients with endoleak	30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary	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
Secondary	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
Secondary	Kinking	Rate of patients with stent graft or bridging stent graft kinking	30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary	Primary patency	Rate of primary patency of bridging stents	30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary	Secondary patency	Rate of secondary patency of bridging stents	30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary	Infection	Rate of patients with stent graft infection	30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stable aneurysm size	Rate of patients with stable aneurysm size	30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary	Decreasing	Rate of patients with decreasing (<5mm) aneurysm size	30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary	Increasing	Rate of patients with increasing (>5mm) aneurysm size	30 days, 3-6, 12, 24, 36, 48, 60 months

External Links

•   Spanish Society for Angiology and Vascular Surgery