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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024525
Receipt No. R000028207
Scientific Title Early and mid-term outcomes of endovascular treatment for chronic aneurysmal aortic dissection
Date of disclosure of the study information 2016/11/25
Last modified on 2017/05/03

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Basic information
Public title Early and mid-term outcomes of endovascular treatment for chronic aneurysmal aortic dissection
Acronym EVT for CAAD
Scientific Title Early and mid-term outcomes of endovascular treatment for chronic aneurysmal aortic dissection
Scientific Title:Acronym EVT for CAAD
Region
Japan

Condition
Condition CAAD
Classification by specialty
Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate endovascular treatment for enlarged chronic aneurysmal aortic dissection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes death
paraplegia
complete thrombosis of false lumen
Key secondary outcomes freedom from re-entry closure
freedom from secondary intervention
remodeling of aorta

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endovascular treatment for CAAD
1-10years
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with clinical course that had elapsed at least one year after the onset of dissection
Key exclusion criteria acute dissection
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Kanaoka
Organization Jikei University School of Medicine
Division name Division of Vascular Surgery, Department of Surgery
Zip code
Address NishiShinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email yujikana@msn.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Kanaoka
Organization Jikei University School of Medicine
Division name Division of Vascular Surgery, Department of Surgery
Zip code
Address NishiShinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email yujikana@msn.com

Sponsor
Institute Division of Vascular Surgery, Department of Surgery Jikei University School of Medicine
Institute
Department

Funding Source
Organization Division of Vascular Surgery, Department of Surgery Jikei University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京慈恵会医科大学

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Early outcomes
No significant differences were observed between the two groups in terms of age, sex, duration from dissection onset to treatment, maximum short axis diameter of the CAAD, preoperative condition, and follow-up observation period, although the duration from dissection onset to treatment tended to be longer in the CE group than in the PE group. Operative death occurred in 1 out of 74 patients (1.4%); 2.3% in the PE group and 0% in CE group. Technical success in the PE and CE groups were 97.6% and 96.8%, respectively. The device most commonly used to perform entry closure was the TAG (W. L. Gore & Associates, Inc., Flagstaff AZ, USA), and no significant difference in the frequency of use was observed between the two groups. 

In the patient that died in the PE group, the tear in the arch could not be closed; therefore, the carotid artery was concomitantly reconstructed using the Chimney method. Furthermore, due to the fact that this patient previously underwent coronary artery bypass grafting using the left internal thoracic artery, the SG was extended proximally after creating a bypass from the left common carotid artery to the left subclavian artery. However, the entry site could not be completely closed and blood pressure decreased during surgery. Unfortunately, the patient died from cardiac failure on the same day due to prolonged hypotension. In one patient in the CE group, we attempted to close a renal artery tear, but a new intimal tear formed. In this case, conversion to open surgical repair was performed the next day and the patient was eventually discharged from the hospital without any major complications. In another patient in the CE group, no central nervous or spinal cord complications were observed, except for delayed paraplegia on postoperative day (POD) 2. 

 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
2017 Year 05 Month 02 Day
Date trial data considered complete
2017 Year 05 Month 02 Day
Date analysis concluded
2017 Year 05 Month 02 Day

Other
Other related information Aortic remodeling
Review of aortic remodeling in the PE group revealed that closure of entry sites that were mainly located on the aortic arch caused rapid expansion of the true lumen of the aortic arch and the descending thoracic aorta. We also observed gradual shrinkage of the diameter of the entire aorta. However, although we observed an expansion of the true lumen of the abdominal aorta, no changes in the aortic diameter were observed. In addition, we discovered that the expansion of the true lumen was approximately 1.8-fold in the thoracic aorta versus 1.3-fold in the abdominal aorta (Table 4). These results indicated that the degree of expansion was also limited.


Management information
Registered date
2016 Year 10 Month 21 Day
Last modified on
2017 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028207

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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