NCT01531725

MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study

6 Months Evaluation of the BIOTRONIK PRO-Kinetic Coronary Stent System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention	Percutaneous coronary intervention

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-04-01
• Completion: 2009-03-01
• First posted: 2012-02-13
• Last updated: 2013-03-25
• Results posted: 2013-03-19