Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices

NCT ID: NCT04016545

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2027-08-01

Brief Summary

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The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.

Detailed Description

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Conditions

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Peri-operative Mortality

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Treated patients

Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)

Intervention Type DEVICE

Aortic aneurysm exclusion through endovascular procedure

Interventions

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Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)

Aortic aneurysm exclusion through endovascular procedure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with indications for elective TEVAR

Exclusion Criteria

* Incapability to provide consent
* Patients not eligible for TEVAR
* Pregnancy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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TINELLI GIOVANNI

Associate Professor of Vascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanni Tinelli

Role: CONTACT

0039 0630157205

Facility Contacts

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Giovanni Tinelli

Role: primary

0039 0630157205

Other Identifiers

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30027/19

Identifier Type: -

Identifier Source: org_study_id

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