Trial Outcomes & Findings for MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study (NCT NCT01531725)

NCT ID: NCT01531725

Last Updated: 2013-03-25

Results Overview

Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 202 participants
• Primary outcome timeframe: at 180 days post procedure
• Results posted on: 2013-03-25

Participant Flow

202 patients at 10 European sites have been enrolled.

Not group assignment.

Participant milestones

Measure	BMS Implantation BMS implantation
Overall Study STARTED	202
Overall Study COMPLETED	197
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	BMS Implantation BMS implantation
Overall Study Protocol Violation	5

Baseline Characteristics

MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study

Baseline characteristics by cohort

Measure	BMS Implantation n=197 Participants Patients with a BMS implanted.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=93 Participants
Age, Categorical >=65 years	100 Participants n=93 Participants
Age Continuous	64.2 years STANDARD_DEVIATION 11.0 • n=93 Participants
Sex: Female, Male Female	56 Participants n=93 Participants
Sex: Female, Male Male	141 Participants n=93 Participants
Region of Enrollment Belgium	83 participants n=93 Participants
Region of Enrollment Netherlands	76 participants n=93 Participants
Region of Enrollment Germany	38 participants n=93 Participants

PRIMARY outcome

Timeframe: at 180 days post procedure

Population: Patients with follow up data available either 180 or 360 days post procedure.

Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.

Outcome measures

Measure	BMS Implantation n=184 Participants BMS implantation
Target Vessel Failure (TVF)	20 participants

SECONDARY outcome

Timeframe: at 180 days post procedure

Population: Patients with follow up available either 180 or 360 days post procedure.

MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.

Outcome measures

Measure	BMS Implantation n=184 Participants BMS implantation
Major Adverse Cardiac Events (MACE)	21 participants

Adverse Events

BMS Implantation

Serious events: 29 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	BMS Implantation n=179 participants at risk BMS implantation
Cardiac disorders Target lesion revascularization	11.2% 20/179 • Number of events 20
Cardiac disorders Myocardial infarction	1.7% 3/179 • Number of events 3
Cardiac disorders Coronary artery bypass graft	1.7% 3/179 • Number of events 3
Cardiac disorders Cardiac death	0.00% 0/179
General disorders Non-cardiac death	1.1% 2/179 • Number of events 2
Cardiac disorders Target vessel revascularization	0.56% 1/179 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Paul Vermeersch, MD, PhD

ZNA Middelheim Department Interventional Cardiology, Antwerpen, Belgium

Phone: +32 3 280 3211

Email: paul.vermeersch@zna.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60