Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR | NCT04100499

Studies
Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR

NCT04100499

Sponsor

Hospital Universitario Ramon y Cajal

Status

Unknown status

Last Update Posted

Feb 11, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Aortic Aneurysm
Thoracic Aortic Aneurysm

Interventions

ESAR (Endosutured Aneurysm Repair)

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Nov 19, 2022Estimated

First Submitted Date

Sep 19, 2019

First Submission Date that Met QC Criteria

Sep 20, 2019

First Posted Date

Sep 24, 2019Actual

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

Feb 8, 2021

Last Update Posted Date

Feb 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrés Reyes Valdivia, Principal Investigator, Hospital Universitario Ramon y CajalPrincipal Investigator

Lead Sponsor

Hospital Universitario Ramon y CajalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR.

The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)

Detailed Description

EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed designed to improve the Endovascular aortic repair. This device is described to mimic an open surgical anastomosis during or after EVAR/TEVAR.

The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study), these outcomes will be described in terms of type IA Endoleaks, migration and sac regression.

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

36 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ESAR (Endosutured Aneurysm Repair)	Device	EndoAnchors adjunctive therapy for EVAR and TEVAR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of participants with type IA Endoleaks	Absence of type IA Endoleaks during follow-up	Three years

Secondary Outcomes

Measure	Description	Time Frame
Rate of participants with Endograft Migration	Analysis of Endograft migration during follow-up	Three years
Rate of participants with Sac regression	Analysis of Sac regression during follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All consecutive patients with adjunctive use of EndoAnchors during or after EVAR and TEVAR

Exclusion Criteria:

Patients that don't want te receive any repair for their disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with abdominal or thoracic aneurysms.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andres Reyes Valdivia, Consultant	Contact	+34629586239		cauzaza@hotmail.com

Overall Officials

Name	Affiliation	Role
Andres Reyes Valdivia, Consultant	Vascular Surgery Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vascular Surgery Department	Recruiting	Madrid		28034	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32558525	Background	Reyes Valdivia A, Duque Santos A, Pitoulias G, Aracil Sanus E, Ocana Guaita J, Gandarias Zuniga C. Predictors of inadequate EndoAnchors aortic wall penetration for the Endosutured therapy in hostile neck patients. J Cardiovasc Surg (Torino). 2020 Dec;61(6):738-744. doi: 10.23736/S0021-9509.20.11248-5. Epub 2020 Jun 19.
32186262

ID	Term
D001014	Aortic Aneurysm
D017545	Aortic Aneurysm, Thoracic

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases