Trial Outcomes & Findings for IVUS Guidance to Reduce Contrast in Coronary Angioplasty (NCT NCT01947335)

Results Overview

Total volume of iodine contrast administered during the index procedure.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

83 participants

Primary outcome timeframe

Day 1

Results posted on

2016-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Angiography-guided PCI Angiography-guided percutaneous coronary intervention	IVUS-guided PCI Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention
Overall Study STARTED	42	41
Overall Study COMPLETED	42	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IVUS Guidance to Reduce Contrast in Coronary Angioplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Angiography-guided PCI n=42 Participants Angiography-guided percutaneous coronary intervention	IVUS-guided PCI n=41 Participants Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention	Total n=83 Participants Total of all reporting groups
Age, Continuous	62.1 years n=99 Participants	67.1 years n=107 Participants	64.6 years n=206 Participants
Sex: Female, Male Female	18 Participants n=99 Participants	17 Participants n=107 Participants	35 Participants n=206 Participants
Sex: Female, Male Male	24 Participants n=99 Participants	24 Participants n=107 Participants	48 Participants n=206 Participants
Region of Enrollment Brazil	42 participants n=99 Participants	41 participants n=107 Participants	83 participants n=206 Participants

PRIMARY outcome

Timeframe: Day 1

Total volume of iodine contrast administered during the index procedure.

Outcome measures

Outcome measures
Measure	Angiography-guided PCI n=42 Participants Angiography-guided percutaneous coronary intervention	IVUS-guided PCI n=41 Participants Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention
Total Volume of Iodine Contrast Used During Procedure	64.5 ml Interval 42.8 to 97.0	20.0 ml Interval 12.5 to 30.0

SECONDARY outcome

Timeframe: 30 days and 6 months

Composite of death, myocardial infarction or repeat revascularization

Outcome measures

Outcome measures
Measure	Angiography-guided PCI n=42 Participants Angiography-guided percutaneous coronary intervention	IVUS-guided PCI n=41 Participants Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention
Major Adverse Cardiac Events 30 days	2 participants	2 participants
Major Adverse Cardiac Events 6-months	2 participants	5 participants

SECONDARY outcome

Timeframe: 7 days

Increase \>= 0.5 mg/dl in basal serum creatinine

Outcome measures

Outcome measures
Measure	Angiography-guided PCI n=42 Participants Angiography-guided percutaneous coronary intervention	IVUS-guided PCI n=41 Participants Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention
Incidence of Contrast-induced Nephropathy	19 percentage of participants	7.3 percentage of participants

Adverse Events

Angiography-guided PCI

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

IVUS-guided PCI

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Angiography-guided PCI n=42 participants at risk Angiography-guided percutaneous coronary intervention	IVUS-guided PCI n=41 participants at risk Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention
Cardiac disorders Periprocedural Infarction	4.8% 2/42 • Number of events 2 • In-hospital	4.9% 2/41 • Number of events 2 • In-hospital
Cardiac disorders Unplanned revascularization	0.00% 0/42 • In-hospital	0.00% 0/41 • In-hospital
Cardiac disorders Stent Thrombosis	0.00% 0/42 • In-hospital	0.00% 0/41 • In-hospital
Cardiac disorders Death	0.00% 0/42 • In-hospital	0.00% 0/41 • In-hospital

Other adverse events

Other adverse events
Measure	Angiography-guided PCI n=42 participants at risk Angiography-guided percutaneous coronary intervention	IVUS-guided PCI n=41 participants at risk Intravascular ultrasound guided percutaneous coronary intervention IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention
Renal and urinary disorders Peak increase in creatinine > 0.5mg/dl	19.0% 8/42 • Number of events 8 • In-hospital	7.3% 3/41 • Number of events 3 • In-hospital

Additional Information

Dr. Pedro A. Lemos

Heart Institute (Incor)

Phone: +55 11 2661 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place