Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001091998
Ethics application status
Not yet submitted
Date submitted
19/09/2011
Date registered
20/10/2011
Date last updated
20/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Jailed Balloon Technique in Side Branch Protection in Coronary Intervention
Scientific title
Jailed balloon technique can protect side branch and make it easier to rewire the jailed side branch during coronary intervention.
Secondary ID [1] 263056 0
Nil
Universal Trial Number (UTN)
U1111-1124-6261
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary artery disease 270791 0
Condition category
Condition code
Cardiovascular 270979 270979 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coronary artery disease patients with side branch arising from target lesions are randomly divided into 2 groups. Group 1 patients will use new technique: leaving 1 small balloon in side branch ostium before main branch stent inflation, proximal part of balloon protruded into the main branch and jailed between the main branch stent and the vessel wall. After inflation of main branch stent at low pressure, if the blood flow of side branch were affected, then the balloon were inflated immediately to recover the side branch blood flow. Rewire the side branch wire through the stent cell and post dilate stent with post-dilation balloon at high pressure to make sure the stent expanded fully. Side branch can be post dilated or stented according to the operator's intention. For one side branch, this technique will occur only once and will spend about 1 hour to finish the whole procedure.
Intervention code [1] 269405 0
Treatment: Devices
Comparator / control treatment
Group 2 patients will use the conventional wire protection technique. Advance a wire to side branch before main branch stenting. After releasing the stent, rewire the side branch. And according to the operater's intention, the main branch or side branch can be post dilated. For one side branch, this technique will occur only once and will spend about 1 hour to finish the whole procedure.
Control group
Active

Outcomes
Primary outcome [1] 279647 0
side branch occlusion rate after the procedure. The side branch occlusion will be diagnosed if the side branch TIMI flow is 0 or 1 grade in angiogram after crossed by main vessel stent.
Timepoint [1] 279647 0
after the procedure
Secondary outcome [1] 294116 0
procedure time
Timepoint [1] 294116 0
immediately after the procedure
Secondary outcome [2] 294117 0
myocadial infarction rate after the procedure. The myocardial infarction will be diagnosed if the CK-MB is elevated 3 times upper limited value. CK-MB will be tested at baseline, 4h, 24hs, 3 days after the procedure.
Timepoint [2] 294117 0
1 day and 3 days after the procedure
Secondary outcome [3] 294118 0
cost related to the procedure. The cost will be recorded by one nurse in cath lab after the procedure. Cath lab is the place where the angiography and coronary intervention is performed.
Timepoint [3] 294118 0
after the procedure
Secondary outcome [4] 294119 0
radiation exposure dose. The exposure dose will be showed on the medical equipment automatically and will be recored by the technician.
Timepoint [4] 294119 0
immediately after the procedure
Secondary outcome [5] 294120 0
chest discomfort during the procedure. The chest discomfort will be assessed by the symptoms and ECG changes.
Timepoint [5] 294120 0
during procedure

Eligibility
Key inclusion criteria
coronary artery disease patients with side branch arising from target lesion
Minimum age
17 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
primary intervention in acute myocardial infarction;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using a randomization table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 3846 0
China
State/province [1] 3846 0

Funding & Sponsors
Funding source category [1] 269875 0
Self funded/Unfunded
Name [1] 269875 0
Luyue Gai
Country [1] 269875 0
China
Primary sponsor type
Individual
Name
Luyue Gai
Address
301 Hospital, 28 Fuxing Road, Haidian District, Beijing 100853
Country
China
Secondary sponsor category [1] 268893 0
Individual
Name [1] 268893 0
Qinhua Jin
Address [1] 268893 0
301 Hospital, 28 Fuxing Road, Haidian District, Beijing 100853
Country [1] 268893 0
China

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271843 0
Ethics Committee of Chinese PLA General Hospital
Ethics committee address [1] 271843 0
28 Fuxing Road, the Chinese PLA General Hospital
Ethics committee country [1] 271843 0
China
Date submitted for ethics approval [1] 271843 0
20/10/2011
Approval date [1] 271843 0
Ethics approval number [1] 271843 0

Summary
Brief summary
To protect side branch more effectively, a new technique called jailed balloon technique were compared with conventional wire protection technique in this study. The hypothetic outcomes of this study are the jailed balloon technique can reduce the rate of side branch occlusion and make it easier to rewire the side branch jailed by stent.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33168 0
Address 33168 0
Country 33168 0
Phone 33168 0
Fax 33168 0
Email 33168 0
Contact person for public queries
Name 16415 0
Qinhua Jin
Address 16415 0
Cardiovascular Department, 301 Hospital, No.28, Fuxing Road,Haidian District, Beijing 100853
Country 16415 0
China
Phone 16415 0
86-13693566076
Fax 16415 0
Email 16415 0
[email protected]
Contact person for scientific queries
Name 7343 0
Qinhua Jin
Address 7343 0
Cardiovascular Department, 301 Hospital, No.28, Fuxing Road,Haidian District, Beijing 100853
Country 7343 0
China
Phone 7343 0
86-13693566076
Fax 7343 0
Email 7343 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.