Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice

Completed

• Conditions: De Novo and Re-stenosed Coronary Artery Lesions

• Registration Number: NCT01056120
• Lead Sponsor: Biotronik AG

Brief Summary

To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Study Start: 2010-03
• Primary Completion: 2013-02
• Study Completion: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1026

Inclusion Criteria

• Patient signed informed consent for data release
• Patient eligible for percutaneous coronary intervention (PCI)
• De novo and re-stenosed coronary artery lesions
• Patient is geographically stable and willing to participate at all follow up assessments
• Patient is > 18 years of age

Exclusion Criteria

• Patient receives more than one stent, which is not a PRO-Kinetic ENERGY stent within the same vessel
• Patient has a known allergy against aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI
• Patient presents with ISR (in-stent restenosis)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI)	6 months

Secondary Outcome Measures

Name	Time	Method
• MACE after 12 and 24 months • TVR after 6, 12 and 24 months • Stent Thrombosis at 6, 12 and 24 months acc. to the academic research consortium -ARC (13)	6,12, 24 Months

Trial Locations

Locations (50)

Landeskrankenhaus Bruck an der Mur; 🇦🇹 Bruck an der Mur, Austria

Kardinal Schwarzenberg'sches Krankenhaus; 🇦🇹 Schwarzach st. Veit, Austria

Saint-Pierre University Hospital; 🇧🇪 Brussels, Belgium

Cliniques Universitaires UCL de Mont-Godinne; 🇧🇪 Yvoir, Belgium

Clinique Axium; 🇫🇷 Aix en Provence, France

Clinique Rhone Durance; 🇫🇷 Avignon, France

Clinique Convert; 🇫🇷 Bourg en Bresse, France

Centre Hospitalier de Chartres; 🇫🇷 Chartres, France

Clinique la Mutualiste; 🇫🇷 Grenoble, France

Clinique Générale de Marignane; 🇫🇷 Marignane, France

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