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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Stanford B Type Aortic Dissection Proximal Tear
• Intervention / Treatment: Device: Endopatch System

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Guo, Professor; Phone Number: 13910758706; Email: Pla301dml@vip.sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese PLA General Hospital
    • Contact: Wei Guo; Phone Number: 13910758706

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endopatch System; Participants will be treated with Endopatch System	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No major adverse events within 30 days after surgery.	Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, liver failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery.	30 days after operation
The success rate of entry tears closure 6 months after operation.	The success rate of intimal tears closure at 6 months is a composite index, including immediate technical success after the operation and no leakage of the intimal tears sealed by the DSA 6 months after the operation, no displacement of the patch, and no second occurrence during the follow-up period.	6 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality, aortic dissection-related mortality, serious adverse events, and device-related adverse events.	All-cause mortality 30 days, 6 months, and 12 months after operation;; Mortality related to aortic dissection 30 days, 6 months, and 12 months after operation;; Incidence of serious adverse events 30 days, 6 months, and 12 months after operation;; Incidence of device-related adverse events 30 days, 6 months, and 12 months after operation.	30 days, 6 months, and 12 months after operation
False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation	False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation.	1 month, 6 months, 12 months after operation
Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation	Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation.	1 month, 6 months, 12 months after operation

Collaborators and Investigators

• Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection
• Other Study ID Numbers: Endopatch V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No