ENDOBARC-S Study: "Endovascular Branched Stent-grafts for... | NCT05309707

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

NCT05309707

Sponsor

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Status

Recruiting

Last Update Posted

Apr 4, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Thoracic Aortic Aneurysm
Thoracic Aortic Dissection
Stent-Graft Endoleak
Stent-Graft Stenosis
Intramural Hematoma
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

Interventions

Endovascular exclusion

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Mar 24, 2022

First Submission Date that Met QC Criteria

Mar 24, 2022

First Posted Date

Apr 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2022

Last Update Posted Date

Apr 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Rate of all-cause mortality in peri-operative periods (all related interventions)	24 hours
Mortality	Rate of all-cause mortality

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Spanish society for Angiology and Vascular Surgery	Recruiting	Madrid		28006	Spain

Label	URL
Spanish Society for Angiology and Vascular Surgery	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Data analyzed by core lab

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D017545	Aortic Aneurysm, Thoracic
D000094629	Dissection, Thoracic Aorta
D001018	Aortic Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D000784	Aortic Dissection
D000094665	Dissection, Blood Vessel
D000094683	Acute Aortic Syndrome