Pilot Study of BAO-G Technique in TAAA Endovascular Repair

NCT ID: NCT06534281

Last Updated: 2024-08-02

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

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2035-12-31

Brief Summary

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Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of thoracoabdominal aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to evaluate the safety and efficacy of BAO-G in thoracoabdominal aortic aneurysm endovascular repair.

Detailed Description

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Conditions

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Aortic Aneurysm, Thoracoabdominal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BAO-G group

Group Type EXPERIMENTAL

BAO-G

Intervention Type PROCEDURE

Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.

Interventions

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BAO-G

Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients with TAAA, confirmed by aortic CTA.
2. TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm.
3. Informed consent signed.

Exclusion Criteria

1. were pregnant.
2. had a history of previous endovascular or open repair.
3. had other contraindications of endovascular treatment.
4. Uncontrolled autoimmune disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liu Bao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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BAO-G-01

Identifier Type: -

Identifier Source: org_study_id

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