Stable AnginaMV:main branchNCT02137486
Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques
An observational study of Stable Angina, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Stable Angina
- How many people
- 214 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2015to 1 Nov 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients revceived coronary intervention between 2009-2014/3.
Who may be able to join
- Angulated bifurcation:MV(main branch) and SB(side branch) angle>70 degree. MV diameter≥2.5mm and eligible for stenting. lesion stenotic severity>70% by QCA(Quantitative coronary analysis). 1 stent strategy. SYNTAX>22 Procedure success. de novo lesion
Who cannot join
- Bifurcation lesions intervention without side br. ballooning after stents deployment or procedure incomplete. Left main coronary artery bifurcational lesions. Elective,provisional or bail-out stenting for side br.
Trial locations and contacts
1 site in 1 country.
About this study
Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. Standard treatment of coronary bifurcation lesions remains controversial manner, especially when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex procedures and certain types of lesions are associated with poor prognosis. There is no standard treatment for such lesions even with the development of drug-eluting stents solve partial problems. The investigators reviewed patients who received coronary intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic relevance of these cases the use of different treatment modalities.
We introduced a retrospective analysis for high angulated bifurcation lesions treated with either DES or BMS.
Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time, fluoroscopy time, procedure success, angiographic success.
- Conditions
- Stable Angina
- Keywords
- stable angina, high angulated bifurcation, SYNTAX, DES, BMS
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sequential ballooning | include BMS or DES | |
| final kissing ballooning | include BMS or DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Major Adverse Cardiac Events(MACE)
Percentage of Participants with major adverse cardiac events(MACE) was defined as rates of target lesion revascularization (TLR) and restenosis during first post-treatment year, and rates of acute, subacute, and late in-stent thrombosis, periprocedure MI(myocardial infarction).
Measured: periprocedure up to 12 months
Percentage of Participants With Cardiovascular Mortality(%)
Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.
Measured: periprocedure up to 12 months
Secondary outcomes (4)
Percentage of Participants With Angiographic Success(%)
Percentage of Participants with angiographic success was defined as residual stenosis<50% under fluoroscopy at the end of procedure.
Measured: periprocedure up to 12 months.
Percentage of Participants With Target Vessel Revascularization Rate
Percentage of Participants with target vessel revascularization rate, both arms
Measured: periprocedure up to 12 months.
Fluoroscopy Time(Minutes) of Each Participants
as medical chart record.
Measured: periprocedure up to 12 months.
Procedure Time(Minutes) of Each Participants
as medical chart record.
Measured: periprocedure up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study start1 Apr 2015
- Primary completion1 Jun 2016
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yueh-Chung, Chen, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137486
- Sponsor's protocol ID
- TCHIRB-1030209-E
- Acronym
- MV:main branch
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2014
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques
- ClinicalTrials.gov ID
- NCT02137486
- Acronym / sponsor ID
- MV:main branch / TCHIRB-1030209-E
- Conditions
- Stable Angina
- Keywords
- stable angina, high angulated bifurcation, SYNTAX, DES, BMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. Standard treatment of coronary bifurcation lesions remains controversial manner, especially when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex procedures and certain types of lesions are associated with poor prognosis. There is no standard treatment for such lesions even with the development of drug-eluting stents solve partial problems. The investigators reviewed patients who received coronary intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic relevance of these cases the use of different treatment modalities.
We introduced a retrospective analysis for high angulated bifurcation lesions treated with either DES or BMS.
Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time, fluoroscopy time, procedure success, angiographic success.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential ballooning | – | –include BMS or DES |
| final kissing ballooning | – | –include BMS or DES |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients revceived coronary intervention between 2009-2014/3.
Key inclusion criteria (1 listed)
- Angulated bifurcation:MV(main branch) and SB(side branch) angle>70 degree. MV diameter≥2.5mm and eligible for stenting. lesion stenotic severity>70% by QCA(Quantitative coronary analysis). 1 stent strategy. SYNTAX>22 Procedure success. de novo lesion
Key exclusion criteria (1 listed)
- Bifurcation lesions intervention without side br. ballooning after stents deployment or procedure incomplete. Left main coronary artery bifurcational lesions. Elective,provisional or bail-out stenting for side br.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Major Adverse Cardiac Events(MACE)
Time frame: periprocedure up to 12 months
Percentage of Participants with major adverse cardiac events(MACE) was defined as rates of target lesion revascularization (TLR) and restenosis during first post-treatment year, and rates of acute, subacute, and late in-stent thrombosis, periprocedure MI(myocardial infarction).
Percentage of Participants With Cardiovascular Mortality(%)
Time frame: periprocedure up to 12 months
Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.
4 secondary outcomes
Percentage of Participants With Angiographic Success(%)
Time frame: periprocedure up to 12 months.
Percentage of Participants With Target Vessel Revascularization Rate
Time frame: periprocedure up to 12 months.
Fluoroscopy Time(Minutes) of Each Participants
Time frame: periprocedure up to 12 months.
Procedure Time(Minutes) of Each Participants
Time frame: periprocedure up to 12 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Major Adverse Cardiac Events(MACE) (time frame: periprocedure up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.