EndovaScular Versus mediCaL mAnagement of Uncomplicated Type B Intramural heMatoma Trial (ESCLAIM)

Summary

This trial is a multicenter, open-label and prospective randomized controlled study to compare 1-year outcomes of uncomplicated type B intramural hematoma (IMH) patients undergoing thoracic endovascular aortic repair (TEVAR) plus optimal medical therapy (OMT) with that of those undergoing OMT alone. The primary objective is to test the hypothesis that 1-year aortic-related adverse events are lower in TEVAR plus OMT group than that in OMT alone group. The secondary objective is to test the hypothesis that 1-year all-cause mortality, aortic-related mortality and re-intervention are lower in TEVAR plus OMT group than that in OMT alone group.

Conditions

• Intramural Hematoma

Interventions

PROCEDURE

Thoracic endovascular aortic repair plus optimal medical therapy

Endovascular treatment (thoracic endovascular aortic repair) plus optimal medical therapy

DRUG

Optimal medical therapy

Optimal medical therapy (strictly control of their blood pressure and heart rate)

Sponsors & Collaborators

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Jiangmen Central Hospital

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• Jieyang People's Hospital

  collaborator OTHER

• Hanyang University

  collaborator OTHER

• Henan Provincial Chest Hospital

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• Guangdong Provincial People's Hospital

  lead OTHER

Principal Investigators

• Jianfang Luo, MD · Guangdong Provincial People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2023-03-01

Completion

2024-03-01

Countries

• China

Study Locations