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Total Endovascular Aortic Arch Re-construction Study(TEARS)

Primary Purpose

Aorta Dissection, Aorta Aneurysm

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ankura Branched/Fenestrated Stent Graft

About this trial

This is an interventional treatment trial for Aorta Dissection focused on measuring Aortic Diseases, Vascular Diseases, Cardiovascular Diseases, Treatment Outcome, Aorta Dissection, Aorta Aneurysm, Aorta pseudoaneurysm, Endovascular aortic repair

Eligibility Criteria

12 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ascending aortic/arch aneurysm
Ascending aortic/arch pseudo-aneurysm
Stanford Type A dissection
Retrograde Stanford Type B dissection
Unclassified dissection with primary tear located in the aortic arch
Able to tolerate endotracheal intubation and general anesthesia
Subject's anatomy must meet the anatomical criteria to receive that implanted device
The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
Availability for the appropriate follow-up visits during the follow-up period
Capability to follow all study requirements

Exclusion Criteria:

ASA classification = V
Severe renal insufficiency defined as SVS risk renal status = 3
Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
Presence of connective tissue disease
Active infection or active vasculitides
Pregnant woman or positive pregnancy test
Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
Subject has had a cerebral vascular accident (CVA) within 2 months.
History of drug abuse
Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
Subject has a known allergy or intolerance to the device components.
Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
Subject has a co-morbidity causing expected survival to be less than 1 year.
Enrolment in another clinical study
Unwillingness to cooperate with study procedures or follow-up visits

Sites / Locations

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular

Arm Description

Total endovascular arch reconstruction

Outcomes

Primary Outcome Measures

cumulative MACE (including death, rupture, paraplegia, aneurysm formation)

Secondary Outcome Measures

Endoleak

Endoleak of all types

Stent-graft migration/kinking

Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention

cumulative cerebrovascular events

Full Information

NCT ID

NCT01496833

First Posted

December 13, 2011

Last Updated

December 30, 2015

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01496833

Brief Title

Total Endovascular Aortic Arch Re-construction Study(TEARS)

Official Title

Total Endovascular Aortic Arch Re-construction Study(TEARS)------China's Registry

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate the short to mid term efficacy and safety of a newly-developed branched stent graft in patients who had complex aortic lesions, such as ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.

Detailed Description

Aneurysms and dissection involving the ascending aorta and aortic arch have historically been treated with open surgical techniques, requiring cardiopulmonary bypass and deep hypothermic circulatory arrest (DHCA). Despite increasing experience and refinement of these procedures, there remains a substantial rate of morality and morbidity. Total endovascular aortic arch and ascending aorta repair is one of the ultimate solutions of these diseases. However, this approach requires extensive technique and new device development. The goal of total endoluminal stent grafting is to re-construct the ascending aorta and aortic arch to cover the primary entry tear of the dissection and to remodel the aorta.Recently, branch and fenestrated stent-grafts has been developed to treat complex ascending and aortic arch disease, which was previously considered to be contraindicated for endovascular repair. This study aims to investigate the short to mid term efficacy and safety of a newly-developed branched stent graft in patients who had complex aortic lesions, such as ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al. Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study designs to enroll 50 patients to be monitored for 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aorta Dissection, Aorta Aneurysm

Keywords

Aortic Diseases, Vascular Diseases, Cardiovascular Diseases, Treatment Outcome, Aorta Dissection, Aorta Aneurysm, Aorta pseudoaneurysm, Endovascular aortic repair

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endovascular

Arm Type

Experimental

Arm Description

Total endovascular arch reconstruction

Intervention Type

Device

Intervention Name(s)

Ankura Branched/Fenestrated Stent Graft

Other Intervention Name(s)

Ankura-TM Stent Graft, Ankura Branched Stent Graft, Ankura Fenestrated Stent Graft

Intervention Description

Ankura Branched/Fenestrated Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）

Primary Outcome Measure Information:

Title

cumulative MACE (including death, rupture, paraplegia, aneurysm formation)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Endoleak

Description

Endoleak of all types

Time Frame

12 months

Title

Stent-graft migration/kinking

Description

Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention

Time Frame

12 months

Title

cumulative cerebrovascular events

Description

cumulative cerebrovascular events

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ascending aortic/arch aneurysm Ascending aortic/arch pseudo-aneurysm Stanford Type A dissection Retrograde Stanford Type B dissection Unclassified dissection with primary tear located in the aortic arch Able to tolerate endotracheal intubation and general anesthesia Subject's anatomy must meet the anatomical criteria to receive that implanted device The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form Availability for the appropriate follow-up visits during the follow-up period Capability to follow all study requirements Exclusion Criteria: ASA classification = V Severe renal insufficiency defined as SVS risk renal status = 3 Severe respiratory insufficiency defined as SVS risk pulmonary status = 3 Presence of connective tissue disease Active infection or active vasculitides Pregnant woman or positive pregnancy test Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment Subject has had a cerebral vascular accident (CVA) within 2 months. History of drug abuse Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion. Subject has a known allergy or intolerance to the device components. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment. Subject has a co-morbidity causing expected survival to be less than 1 year. Enrolment in another clinical study Unwillingness to cooperate with study procedures or follow-up visits

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Yang, MD,PhD

Phone

86-13892828016

yangjian1212@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Yang, MD,PhD

Organizational Affiliation

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dinghua Yi, M.D., PhD.

Organizational Affiliation

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Yang, MD,PhD

12. IPD Sharing Statement

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Total Endovascular Aortic Arch Re-construction Study(TEARS)

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