search
Back to results

Endovascular Aortic Repair for Aortic Dissection

Primary Purpose

Aorta Dissection, Aorta Aneurysm

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stent Graft (Medtronic, Microport, Ankura)
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • Descending aortic/arch aneurysm
  • Descending aortic/arch pseudo-aneurysm
  • 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.
  • Enrollment 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

Stent Graft

Arm Description

TEVAR procedure using devices include Medtronic Stent Graft（Medtronic Medtronic, Inc., US） Microport Stent Graft（Microport Co.,LTD.，Shanghai, China） Ankura Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）.

Outcomes

Primary Outcome Measures

Cumulative major adverse cardiac events (MACE)
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)

Secondary Outcome Measures

Endoleak
Endoleak of all types from the stent graft
Stent-graft migration/kinking
Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention

Full Information

First Posted
December 22, 2011
Last Updated
December 30, 2015
Sponsor
Xijing Hospital
Collaborators
Changhai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01505309
Brief Title
Endovascular Aortic Repair for Aortic Dissection
Official Title
Endovascular Aortic Repair for Aortic Dissection------XiJing Registry
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
Changhai 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 Thoracic Endovascular Aortic Repair (TEVAR) in patients who had aortic lesions, such as descending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.
Detailed Description
Aneurysms and dissection involving the descending 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. The goal of Thoracic Endovascular Aortic Repair (TEVAR) is to re-construct the descending aorta and aortic arch to cover the primary entry tear of the dissection and to remodel the aorta. TEVAR technique were performed with various devices available. The purpose of this study is to investigate the short to mid term efficacy and safety of Thoracic Endovascular Aortic Repair (TEVAR) in patients who had aortic lesions, such as descending aortic/arch aneurysm, pseudo-aneurysm, 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
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stent Graft
Arm Type
Experimental
Arm Description
TEVAR procedure using devices include Medtronic Stent Graft（Medtronic Medtronic, Inc., US） Microport Stent Graft（Microport Co.,LTD.，Shanghai, China） Ankura Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）.
Intervention Type
Device
Intervention Name(s)
Stent Graft (Medtronic, Microport, Ankura)
Other Intervention Name(s)
Medtronic Stent Graft, Microport Stent Graft, Ankura Stent Graft
Intervention Description
Medtronic Stent Graft（Medtronic Medtronic, Inc., US） Microport Stent Graft（Microport Co.,LTD.，Shanghai, China） Ankura Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）
Primary Outcome Measure Information:
Title
Cumulative major adverse cardiac events (MACE)
Description
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Endoleak
Description
Endoleak of all types from the stent graft
Time Frame
24 months
Title
Stent-graft migration/kinking
Description
Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Descending aortic/arch aneurysm Descending aortic/arch pseudo-aneurysm 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. Enrollment 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
Email
yangjian1212@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Yang, M.D., Ph.D
Organizational Affiliation
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Official's Role
Principal Investigator
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, M.D.,Ph.D

12. IPD Sharing Statement

Learn more about this trial

Endovascular Aortic Repair for Aortic Dissection

We'll reach out to this number within 24 hrs