Trial Outcomes & Findings for Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques (NCT NCT02137486)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

214 participants

Primary outcome timeframe

periprocedure up to 12 months

Results posted on

2019-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	112	102
Overall Study COMPLETED	112	102
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequential Ballooning n=112 Participants treated with drug eluting stent or bare metal stent.	Final Kissing Ballooning n=102 Participants treated with drug eluting stent or bare metal stent.	Total n=214 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=5 Participants	78 Participants n=7 Participants	160 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants
Age, Continuous	68.69 years STANDARD_DEVIATION 11.43 • n=5 Participants	67.67 years STANDARD_DEVIATION 11.49 • n=7 Participants	67.98 years STANDARD_DEVIATION 11.54 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	81 Participants n=7 Participants	168 Participants n=5 Participants
Region of Enrollment Taiwan	112 participants n=5 Participants	102 participants n=7 Participants	214 participants n=5 Participants

PRIMARY outcome

Timeframe: periprocedure up to 12 months

Population: 100%x2/112; 100%x7/102

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).

Outcome measures

Outcome measures
Measure	Sequential Ballooning n=112 Participants treated with drug eluting stent or bare metal stent.	Final Kissing Ballooning n=102 Participants treated with drug eluting stent or bare metal stent.
Percentage of Participants With Major Adverse Cardiac Events(MACE)	1.72 percentage of participants Interval 1.24 to 1.98	6.86 percentage of participants Interval 6.01 to 7.14

PRIMARY outcome

Timeframe: periprocedure up to 12 months

Population: 100%x0/112; 100%x1/102

Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.

Outcome measures

Outcome measures
Measure	Sequential Ballooning n=112 Participants treated with drug eluting stent or bare metal stent.	Final Kissing Ballooning n=102 Participants treated with drug eluting stent or bare metal stent.
Percentage of Participants With Cardiovascular Mortality(%)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: periprocedure up to 12 months.

Population: lesions of participants; 100%x90/112; 100%x84/102.

Percentage of Participants with angiographic success was defined as residual stenosis\<50% under fluoroscopy at the end of procedure.

Outcome measures

Outcome measures
Measure	Sequential Ballooning n=112 Participants treated with drug eluting stent or bare metal stent.	Final Kissing Ballooning n=102 Participants treated with drug eluting stent or bare metal stent.
Percentage of Participants With Angiographic Success(%)	90 Participants	84 Participants

SECONDARY outcome

Timeframe: periprocedure up to 12 months.

Population: Percentage of Participants with target vessel revascularization rate, both arms

Percentage of Participants with target vessel revascularization rate, both arms

Outcome measures

Outcome measures
Measure	Sequential Ballooning n=112 Participants treated with drug eluting stent or bare metal stent.	Final Kissing Ballooning n=102 Participants treated with drug eluting stent or bare metal stent.
Percentage of Participants With Target Vessel Revascularization Rate	24 Participants	19 Participants

SECONDARY outcome

Timeframe: periprocedure up to 12 months.

Population: fluoroscopy time(minutes) of each participants

as medical chart record.

Outcome measures

Outcome measures
Measure	Sequential Ballooning n=112 Participants treated with drug eluting stent or bare metal stent.	Final Kissing Ballooning n=102 Participants treated with drug eluting stent or bare metal stent.
Fluoroscopy Time(Minutes) of Each Participants	24 minutes Standard Deviation 6	36 minutes Standard Deviation 4

SECONDARY outcome

Timeframe: periprocedure up to 12 months.

Population: procedure time(minutes) of each participants

as medical chart record.

Outcome measures

Outcome measures
Measure	Sequential Ballooning n=112 Participants treated with drug eluting stent or bare metal stent.	Final Kissing Ballooning n=102 Participants treated with drug eluting stent or bare metal stent.
Procedure Time(Minutes) of Each Participants	84 minutes Standard Deviation 8	92 minutes Standard Deviation 4

Adverse Events

Sequential Ballooning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Final Kissing Ballooning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

taipei city hospital Ren-Ai branch

cardiovascular section

Phone: 0088627093600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place