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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequential ballooning | include BMS or DES | ||
| final kissing ballooning | include BMS or DES |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | periprocedure up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | periprocedure up to 12 months. |
| Percentage of Participants With Target Vessel Revascularization Rate |
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Inclusion Criteria:
Exclusion Criteria:
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patients revceived coronary intervention between 2009-2014/3.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei city hospital | Taipei | 52005 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequential Ballooning | the stent is placed in the MV and dilated, and then a second balloon just proximal to the opening of the SB is dilated in order to widen the diameter of the MV at the SV opening to allow more blood to be diverted into the SB; then treated with drug eluting stent or bare metal stent. |
| FG001 | Final Kissing Ballooning | a balloon that extends from a position in the MV just proximal to the SB into a portion of the SB is inflated at the same time as the MV balloon; then treated with drug eluting stent or bare metal stent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
high angle bifurcation lesion
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequential Ballooning | treated with drug eluting stent or bare metal stent. |
| BG001 | Final Kissing Ballooning | treated with drug eluting stent or bare metal stent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 100%x2/112; 100%x7/102 | Posted | Number | 95% Confidence Interval | percentage of participants | periprocedure up to 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sequential Ballooning | treated with drug eluting stent or bare metal stent. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| taipei city hospital Ren-Ai branch | cardiovascular section | 0088627093600 | 3741 | chenyuehchung.tw@yahoo.com.tw |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Percentage of Participants with target vessel revascularization rate, both arms |
| periprocedure up to 12 months. |
| Fluoroscopy Time(Minutes) of Each Participants | as medical chart record. | periprocedure up to 12 months. |
| Procedure Time(Minutes) of Each Participants | as medical chart record. | periprocedure up to 12 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percentage of Participants With Cardiovascular Mortality(%) | Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years. | 100%x0/112; 100%x1/102 | Posted | Count of Participants | Participants | periprocedure up to 12 months |
|
|
|
| Secondary | 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. | lesions of participants; 100%x90/112; 100%x84/102. | Posted | Count of Participants | Participants | periprocedure up to 12 months. |
|
|
|
| Secondary | Percentage of Participants With Target Vessel Revascularization Rate | Percentage of Participants with target vessel revascularization rate, both arms | Percentage of Participants with target vessel revascularization rate, both arms | Posted | Count of Participants | Participants | periprocedure up to 12 months. |
|
|
|
| Secondary | Fluoroscopy Time(Minutes) of Each Participants | as medical chart record. | fluoroscopy time(minutes) of each participants | Posted | Mean | Standard Deviation | minutes | periprocedure up to 12 months. |
|
|
|
| Secondary | Procedure Time(Minutes) of Each Participants | as medical chart record. | procedure time(minutes) of each participants | Posted | Mean | Standard Deviation | minutes | periprocedure up to 12 months. |
|
|
|
| 112 |
| 0 |
| 112 |
| 0 |
| 112 |
| EG001 | Final Kissing Ballooning | treated with drug eluting stent or bare metal stent. | 1 | 102 | 0 | 102 | 0 | 102 |
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| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |