MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study (MULTIBENE)
The primary objective of this study is to evaluate safety and efficacy of the BIOTRONIK PRO-Kinetic coronary CoCr-stent in patients with single de novo lesions of native coronary arteries.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||6 Months Evaluation of the BIOTRONIK PRO-Kinetic Coronary Stent System|
- Target Vessel Failure (TVF) [ Time Frame: at 180 days post procedure ] [ Designated as safety issue: Yes ]Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.
- Major Adverse Cardiac Events (MACE) [ Time Frame: at 180 days post procedure ] [ Designated as safety issue: Yes ]MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.
|Study Start Date:||February 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: BMS implantation
Patients meeting the inclusion criteria and none of the exclusion criteria are treated by implanting the study device (the ProKinetic bare metal stent). Since it is a single arm study design, no patients are enrolled to a control arm.
Device: Percutaneous coronary intervention
Percutaneous coronary intervention
Other Name: PRO-Kinetic stent system
The PRO-Kinetic study is a multi-center, prospective, consecutive non-randomized study enrolling 200 patients with single de novo lesions in native coronary arteries meeting the entry criteria. Those who provide informed consent will be enrolled to receive the PRO-Kinetic stent. Telephone follow-up will be performed at 1 month for all enrolled patients. After 6 months 100 patients will have an angiographic follow-up and 100 patients will be checked by telephone again. Additionally, a clinical telephone follow-up will be performed in all patients after 12 months.
This study is designed to yield data on the clinical safety and efficacy of the PRO-Kinetic stent in the coronary artery application. The Target Vessel Failure Rate after 6 months shall be below 18 % (max. 35 Serious Adverse Events and Expedited Events) to show a safety/performance profile that could be considered in the range of the currently available bare metal stent systems
|Principal Investigator:||Paul Vermeersch, MD, PhD||ZNA Middelheim, Department Interventional Cardiology|
|Principal Investigator:||Maarten J. Suttorp, MD, PhD||St Antonius Hospital Nieuwegein|