MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study (MULTIBENE)
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|ClinicalTrials.gov Identifier: NCT01531725|
Recruitment Status : Completed
First Posted : February 13, 2012
Results First Posted : March 19, 2013
Last Update Posted : March 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Percutaneous coronary intervention||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||6 Months Evaluation of the BIOTRONIK PRO-Kinetic Coronary Stent System|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||March 2009|
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
- Target Vessel Failure (TVF) [ Time Frame: at 180 days post procedure ]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 ]MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531725
|Principal Investigator:||Paul Vermeersch, MD, PhD||ZNA Middelheim, Department Interventional Cardiology|
|Principal Investigator:||Maarten J. Suttorp, MD, PhD||ST. Antonius hospital Nieuwegein|