Safety and Efficacy of the Minimally Invasive Bentall Procedure Via a Small Right Intercostal Incision in Patients With Aortic Root Lesions

NCT ID: NCT06177548

Last Updated: 2024-07-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-11

Study Completion Date

2024-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study intends to include patients who had aortic root lesions and were treated with Bentall surgery from January 2019 to July 2023 in the First Affiliated Hospital of Xi'an Jiaotong University. The patients will be divided into the minimally invasive group and control group according to the surgical methods: the former underwent minimally invasive Bentall surgery through a small right intercostal incision; the latter underwent traditional Bentall surgery through a median sternal incision. By comparing the clinical data of patients in two groups, we will investigate the effect and safety of minimally invasive Bentall surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Dissection Aortic Root Aneurysm Minimally Invasive Surgical Procedures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Minimally invasive Group

Patients who underwent minimally invasive Bentall procedure will be included. The minimally invasive Bentall procedure is performed through a small incision in the right intercostal space.

Minimally invasive Bentall procedure

Intervention Type PROCEDURE

The minimally invasive Bentall procedure is performed through a small incision in the right intercostal space.

Control Group

Patient who underwent Bentall procedure through median sternotomy will be included.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Minimally invasive Bentall procedure

The minimally invasive Bentall procedure is performed through a small incision in the right intercostal space.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Patients who were diagnosed with aortic root lesions and treated with the Bentall procedure at the First Affiliated Hospital of Xi'an Jiaotong University from January 2019 to July 2023 will be included in this study.

Exclusion Criteria

* Previous sternotomy or aortic root surgery;
* Combined coronary artery disease requiring simultaneous coronary revascularization;
* Combined aortic arch lesions requiring simultaneous aortic arch surgery;
* Preoperative comorbidities with severe single or multiple organ failure;
* Incomplete clinical information;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yang Yan

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital of Xi'an Jiantong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yan Yang

Role: CONTACT

+86.29.85323869

Li Guoliang

Role: CONTACT

+86.29.85323869

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guoliang Li

Role: primary

008613759982523

Yang Yan

Role: backup

+86.29.85323869

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJTU1AF2023LSK-434

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pilot Study of BAO-G Technique in TAAA Endovascular Repair
NCT06534281 ENROLLING_BY_INVITATION EARLY_PHASE1
Endovascular Treatment of Thoracic Aortic Disease
NCT00583817 ENROLLING_BY_INVITATION NA