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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05309707
Other study ID # 2022-03
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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