UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024525 |
|---|---|
| Receipt number | 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 16:20:32 |
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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
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
yujikana@msn.com
Sponsor or person
Institute
Division of Vascular Surgery, Department of Surgery Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028207
