Trial Outcomes & Findings for RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population (NCT NCT00752128)

Last Updated: 2013-04-25

Results Overview

Recruitment status

COMPLETED

Target enrollment

2349 participants

Primary outcome timeframe

12 Months

Results posted on

2013-04-25

Start recruitment: August 28, 2008 \> End recruitment: March 19, 2009

Reasons for withdrawal
Measure	Resolute Drug-Eluting Stent
Overall Study Withdrawal by Subject	4

RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population

Baseline characteristics by cohort
Measure	Resolute Drug-Eluting Stent n=2349 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1260 Participants n=5 Participants
Age, Categorical >=65 years	1089 Participants n=5 Participants
Age Continuous	63.5 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	521 Participants n=5 Participants
Sex: Female, Male Male	1828 Participants n=5 Participants
Region of Enrollment Europe	2118 participants n=5 Participants
Region of Enrollment India	174 participants n=5 Participants
Region of Enrollment Argentina	17 participants n=5 Participants
Region of Enrollment South Africa	40 participants n=5 Participants

Timeframe: 12 Months

Population: Analysis per intention to treat

Outcome measures
Measure	Cardiac Death or Target Vessel MI n=2334 Participants Percentage of participants that had either Cardiac Death or Myocardial Infarction (not clearly attributable to a non-target vessel)
Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)	4.2 percentage of participants

Timeframe: 12 Months

Population: Intention to treat

Outcome measures
Measure	Cardiac Death or Target Vessel MI n=2334 Participants Percentage of participants that had either Cardiac Death or Myocardial Infarction (not clearly attributable to a non-target vessel)
Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition	0.9 percentage of participants

Serious events: 33 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Resolute Drug-Eluting Stent n=2334 participants at risk
Cardiac disorders Cardiac Death	1.4% 33/2334 • Number of events 2334

Adverse event data not reported

Medtronic Bakken Research Center B.V.

Phone: +3143356

Restriction type: OTHER