Guo's Entry Tear Repair :The First in Man Study of Endopatch System

NCT ID: NCT04745039

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2023-12-15

Brief Summary

A prospective, single-center, first in man study to evaluate the safety and efficacy of Endopatch System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the Chronic Stanford B type aortic dissection proximal tear.

Conditions

Chronic Stanford B Type Aortic Dissection Proximal Tear

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endopatch System

Participants will be treated with Endopatch System

Group Type: EXPERIMENTAL

Endopatch System

Intervention Type: DEVICE

The patch system for aortic dissection tear is composed of a dissection tear patch system and an adjustable bend conveyor. The patch system is composed of a patch and a conveying steel cable. The patch is pre-installed on the conveying steel cable.

Interventions

Endopatch System

The patch system for aortic dissection tear is composed of a dissection tear patch system and an adjustable bend conveyor. The patch system is composed of a patch and a conveying steel cable. The patch is pre-installed on the conveying steel cable.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18 to 80 years old, no gender limitation;

2. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol;

3. Diagnosed as chronic Stanford type B aortic dissection;

4. Maximum diameter of the intimal tears is between 2mm and 20mm;

5. Important branch vessels will not be covered after intimal tears closure;

6. Aortic endovascular treatment can be performed with appropriate arterial access.

Exclusion Criteria

1. Diagnosed as acute, subacute aortic dissection;

2. Intermural hematoma, aortic ulcer, pseudoaneurysm, and severe aortic calcification;

3. The minimum distance between the intimal tears of the aortic intimal flaps and the root of the intimal flaps is less than the radius of the patch to be used (the patch cannot be deployed flat);

4. Pregnant, breastfeeding or cannot contraception during the trial period;

5. Participated in clinical trials of other drugs or devices during the same period;

6. The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.), and the postoperative drug treatment plan is therefore affected;

7. Allergic to contrast agents, anesthetics, patches, and delivery materials;

8. Cannot tolerate anesthesia;

9. Severe liver, kidney, lung, and heart function abnormalities before surgery [Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination];

10. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;

11. Life expectancy is less than 12 months (such as advanced malignant tumors)

12. Acute systemic infection

13. Investigator judged that not suitable for interventional treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Endonom Medtech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese PLA General Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Guo, Professor

Role: CONTACT

Pla301dml@vip.sina.com

13910758706

Facility Contacts

Wei Guo

Role: primary

13910758706

References

Ge YY, Zhang HP, Guo W. A Novel Endovascular Double-Disc Implant for Sealing Intimal Tears in Aortic Dissection. JACC Asia. 2023 Nov 21;3(6):937-941. doi: 10.1016/j.jacasi.2023.09.009. eCollection 2023 Dec.

Reference Type: DERIVED

PMID: 38155784 (View on PubMed)

Other Identifiers

Endopatch V1.0

Identifier Type: -

Identifier Source: org_study_id