Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(Graft Study)

Hangzhou Endonom Medtech Co., Ltd.4 sites in 1 country20 target enrollmentNovember 10, 2022

ConditionsAortic Aneurysm and Dissection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Aneurysm and Dissection
Sponsor: Hangzhou Endonom Medtech Co., Ltd.
Enrollment: 20
Locations: 4
Primary Endpoint: All-cause mortality and major stroke within 12 months after surgery.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm

Detailed Description

The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and aneurysm.

Registry

clinicaltrials.gov

Start Date

November 10, 2022

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hangzhou Endonom Medtech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged 18 to 80 years old.
•The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
•Patients showing a suitable vascular condition, including:
•Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
•Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
•Proximal anchoring zone length ≥ 30 mm;
•Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
•Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
•Suitable arterial access for endovascular interventional treatment ;
•Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.

Exclusion Criteria

•Patients that have experienced systemic infection during past three months;
•Neck surgery was performed within three months;
•Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
•Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
•Heart transplant patients;
•Patients that have suffered MI or stroke during past three months;
•Patients with Class IV heart function (NYHA classification) or LVEF\<30%
•Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
•Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 × 109/L), acute anemia (Hb \< 90 g/L); thrombocytopenia (PLT count \< 50 × 109/L);
•Patients with renal insufficiency， serum creatinine \> 150 umol/l (or 3.0 mg/dl) and / or end-stage renal disease requiring renal dialysis shall be determined by the investigator after comprehensive analysis;

Outcomes

Primary Outcomes

All-cause mortality and major stroke within 12 months after surgery.

Time Frame: 12 months post-intervention

All-cause mortality includes cardiac mortality, non-cardiac mortality and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset

Secondary Outcomes

Major adverse events occurring within 30 days after surgery.(within 30 days after surgery)
Incidence of severe adverse events.(within 12 months post-intervention)
Aortic remodeling results.(1 month, 6 months and 12 months post-intervention)
Aortic-related mortality within 12 months post operation.(within 12 months post operation)