None listed
Conditions
Brief summary
The purpose of this registry is to collect post marketing surveillance data on patients receiving at least one Genous Bio-engineered R stent. Scientific data from this registry will be presented and published.
Interventions
The e-Healing registry is a 5000 patients internet based registry (50 patients will be recruited for one site and 5000 patients will be recurited globally). The Genous Bio-engineered R stent is used for the treatment of a group of selected patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to de novo and/or restenotic coronary artery lesions. The Genous Bio-engineered R stent is a coronary balloon expandable vascular prosthesis. The primary objective of this registry is to collect post marketing surveillance data on patients receiving at least one Genous Bio-engineered R stent when used according to the Instructions for Use. Specifically, data will be collected in order to assess clinical outcomes and safety of patients out to 12 months post procedure receiving at least one Genous Bio-engineered R stent. In addition, the registry is designed to identify any potential unanticipated adverse device-related effects that may not have been noted prior to market approval, to collect data on procedural practices and demographic characteristics and to determine how these variables effect clinical outcomes. The duration of this Registry is 18 months (from the beginning of patient enrollment to the end of patient follow-up).
Sponsors
Study design
Eligibility
Inclusion criteria
A group of selected patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to de novo and/or restenotic coronary artery lesions. The Genous stent is suitable for treatment of atherosclerotic or restenotic lesions with a length less than the nominal stent length in coronary arteries having reference vessel diameters of the stent expanded diameter following primary inflation.
Exclusion criteria
Patients who have previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA).