Trials Sponsors Conditions Drugs Pricing

Conditions

Aortic Arch; Aneurysm, Dissecting

Keywords

Aortic ArchAneurysmDissectingUlcers

Outcome Measures

Primary Outcomes (1)

Rate of no major adverse events related to device or surgery
Major adverse events related to device or surgery include: stroke, respiratory failure, pericardial tamponade, dissection or aneurysm rupture, paraplegia, stent occlusion, stent bend, stent displacement, thrombosis or rupture of the approach vessel, switch to open surgery, death, etc.
30 days after surgery

Secondary Outcomes (5)

Technical success rate
immediately after the surgery
Immediate surgery success rate
immediately after the surgery
The clinical success rate
12 months after the surgery
The incidence rate of secondary operations within 12 months after surgery
12 months after surgery
Adverse event rate within 12 months after surgery
12 months after surgery

Study Arms (1)

WeFlow-Arch Moduler Embedded Branch Stent Graft System

EXPERIMENTAL

Device: WeFlow-Ach Moduler Embedded Branch Stent Graft System

Interventions

WeFlow-Ach Moduler Embedded Branch Stent Graft SystemDevice

The modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system.

WeFlow-Arch Moduler Embedded Branch Stent Graft System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients aged 18 to 85 years old；
Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, dissection and ulcers involving the aortic arch;

Sponsors & Collaborators

Hangzhou Endonom Medtech Co., Ltd.
Industrylead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

MeSH Terms

Conditions

AneurysmUlcer

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 21, 2021

Study Start

February 28, 2019

Actual (reported)

Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft System

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

WeFlow-Arch Moduler Embedded Branch Stent Graft System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

WeFlow-Arch Moduler Embedded Branch Stent Graft System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations