Trial Outcomes & Findings for Comparison of StentOptimizer With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography (NCT NCT00973921)

Results Overview

IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, The SO software was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

On the procedure day

Results posted on

2014-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Coronary Stenting Evaluation With IVUS The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
Overall Study STARTED	40
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Coronary Stenting Evaluation With IVUS The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
Overall Study IVUS results were not available	9

Baseline Characteristics

Comparison of StentOptimizer With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coronary Stenting Evaluation With IVUS n=40 Participants The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants
Age, Continuous	62.2 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: On the procedure day

Population: Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.

IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, The SO software was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.

Outcome measures

Outcome measures
Measure	Coronary Stenting Evaluation With IVUS n=31 Participants The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard.	100 percentage of correct decisions by SO

PRIMARY outcome

Timeframe: On procedure day

Population: Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.

IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, QCA analysis was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.

Outcome measures

Outcome measures
Measure	Coronary Stenting Evaluation With IVUS n=31 Participants The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.	74.2 percentage of correct decision by QCA

SECONDARY outcome

Timeframe: On day of procedure

Population: Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.

The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by SO and by IVUS.

Outcome measures

Outcome measures
Measure	Coronary Stenting Evaluation With IVUS n=31 Participants The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .	0.1 mm Standard Deviation 0.4

SECONDARY outcome

Timeframe: On day of procedure

Population: Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.

The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS

Outcome measures

Outcome measures
Measure	Coronary Stenting Evaluation With IVUS n=31 Participants The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
Correlation of Stent Diameter Measurements Between the QCA and IVUS .	0.3 mm Standard Deviation 0.4

Adverse Events

Coronary Stenting Evaluation With IVUS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Giora Weisz MD

Columbia University Medical Center

Phone: 212-305 7060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place