NCT01496833

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
3 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

3.9 years

First QC Date

December 13, 2011

Last Update Submit

December 30, 2015

Conditions

Aorta DissectionAorta Aneurysm

Keywords

Aortic DiseasesVascular DiseasesCardiovascular DiseasesTreatment OutcomeAorta DissectionAorta AneurysmAorta pseudoaneurysmEndovascular aortic repair

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (3)

  • Endoleak

    12 months

  • Stent-graft migration/kinking

    12 months

  • cumulative cerebrovascular events

    12 months

Study Arms (1)

Endovascular

EXPERIMENTAL

Total endovascular arch reconstruction

Device: Ankura Branched/Fenestrated Stent Graft

Interventions

Ankura Branched/Fenestrated Stent GraftDEVICE

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

Also known as: Ankura-TM Stent Graft, Ankura Branched Stent Graft, Ankura Fenestrated Stent Graft
Endovascular

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Aortic DissectionAortic AneurysmAortic DiseasesVascular DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmAcute Aortic Syndrome

Study Officials

  • Jian Yang, MD,PhD

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

    PRINCIPAL INVESTIGATOR

  • Dinghua Yi, M.D., PhD.

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

    STUDY CHAIR

Central Study Contacts

Jian Yang, MD,PhD

CONTACT

86-13892828016yangjian1212@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 21, 2011

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 1, 2016

Record last verified: 2015-12

Locations

CN(1)