Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Drug-eluting stent
Brief summary
The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound that is designed to reduce restenosis. This prospective multi-center study has been initiated: * To document the acute and mid-term safety and overall clinical performance of the stent system in a real world patient population requiring stent implantation. * To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.
Interventions
DEVICEEndeavor Zotarolimus Eluting Coronary Stent
Drug eluting stent
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is \>18 years of age (or minimum age as required by local regulation) * The patient has consented to participate by signing the Patient Informed Consent Form and/or has authorized the collection and release of his medical information by signing the Patient Data Release Consent Form. * The patient is suitable for implantation of one or more Endeavor(TM) ABT-578 Eluting Coronary Stent System in one or more native artery target lesions. * Lesion length and vessel diameter of the target lesion(s) are according to the Indications for Use as mentioned in the Instructions for Use that comes with every Endeavor(TM) ABT-578 Eluting Coronary Stent System. * The patient is willing and able to cooperate with registry procedures and required follow up visits.
Exclusion criteria
* Women with known pregnancy or who are lactating. * Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media. * Patients in whom anti-platelet and/pr anticoagulation therapy is contraindicated. * Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon. * Current medical condition with a life expectancy of less than 12 months. * The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this E-five registry once. * Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE (Major Adverse Cardiac Events) | 12 Months | MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery)) |
Participant flow
Recruitment details
Consecutive patients with an indication for coronary stent implantation according to the Instructions For Use of the Endeavor Coronary Stent, in whom it is an intent to implant one or more Endeavor Coronary Stents should be included (provided patient consent).
Pre-assignment details
All enrolled subjects were followed for 12 months. An extended 2-year follow-up was performed in 2116 subjects from 26 centers.
Participants by arm
| Arm | Count |
|---|---|
| Endeavor Coronary Stent Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent | 8,314 |
| Total | 8,314 |
Baseline characteristics
| Characteristic | Endeavor Coronary Stent |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4048 Participants |
| Age, Categorical Between 18 and 65 years | 4266 Participants |
| Age, Continuous | 63.29 years STANDARD_DEVIATION 11.06 |
| Diabetes Mellitus IDDM (Insulin Dependent Diabetes Mellitus) | 682 Participants |
| Diabetes Mellitus No Diabetes Mellitus | 5593 Participants |
| Diabetes Mellitus Non-IDDM (Non-Insulin Dependent Diabetes Mellitus) | 2039 Participants |
| Region of Enrollment Africa | 6 participants |
| Region of Enrollment Europe | 6566 participants |
| Region of Enrollment India | 586 participants |
| Region of Enrollment Pacifica | 57 participants |
| Region of Enrollment South America | 220 participants |
| Region of Enrollment Southeast Asia | 879 participants |
| Sex: Female, Male Female | 1940 Participants |
| Sex: Female, Male Male | 6374 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7,832 |
| serious Total, serious adverse events | 135 / 7,832 |
Outcome results
Primary
MACE (Major Adverse Cardiac Events)
MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))
Time frame: 12 Months
Population: Intention to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endeavor Coronary Stent | MACE (Major Adverse Cardiac Events) | 7.5 Percentage of participants |