Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
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.
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Conditions
De Novo and Re-stenosed Coronary Artery Lesions
Intervention
Pro Kinetic Energy bare metal stent
Location
Westdeutsches Herzzentrum Essen
Essen
NRW
Germany
45122
Status
Not yet recruiting
Source
Biotronik AG
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01056120
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Coronary Aneurysm
Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.
Coronary Vessel Anomalies
Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.
Coronary Occlusion
Complete blockage of blood flow through one of the CORONARY ARTERIES, usually from CORONARY ATHEROSCLEROSIS.
Bioelectric Energy Sources
Electric power supply devices which convert biological energy, such as chemical energy of metabolism or mechanical energy of periodic movements, into electrical energy.
Internal Mammary-coronary Artery Anastomosis
Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.
Clinical Trials
The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.
The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary...
Sirolimus-Eluting Stent Versus Standard Stent in Diabetic
The purpose of this study was to determine whether Sirolimus stent implantation is effective in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with de...
GISSOC II: Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions
The objective of this study is to compare the Cypher Select-TM Sirolimus Eluting Stent (SES) with the SONIC-TM Bare Metal Stent (BMS) in the treatment of Chronic Total Occlusion lesions (C...
Drug-eluting Balloon in Acute Myocardial Infarction
The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combinati...
The study will enroll patients with angiographically significant coronary de novo lesions. Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after bare-m...
PubMed Articles
OBJECTIVES: This study examined whether sirolimus-eluting stent (SES) implantation exerts an anti-proliferative action on a bare metal stent (BMS) placed distally in the same coronary artery. BACKGROU...
Objective To evaluate the mid-term outcomes of sirolimus-eluting stents (SES; Cypher Bx Velocity) for de novo coronary stenosis in a Japanese clinical setting, and to compare these with the outcomes u...
Fourteen years previously, a 67-year-old man underwent percutaneous coronary intervention (PCI) for proximal left anterior descending artery lesion with a bare metal stent (BMS) for acute myocardial i...
Aims: To test the efficacy of sequential application of drug-coated balloon (DCB) and bare metal stent (BMS) for treatment of de novo coronary lesions, comparing the sequence of application (DCB first...
OBJECTIVES: We aimed to evaluate the long-term safety and efficacy of drug-eluting stent (DES) implantation in the treatment of diffuse bare metal stent (BMS) restenosis as compared to the treatment o...
