Endeavor primary percutaneous coronary intervention (PCI) study

Completed

• Conditions: Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular; Circulatory System; Acute myocardial infarction

• Registration Number: ISRCTN66301072
• Lead Sponsor: Medtronic Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. The patient is greater than 18 years, either sex
2. The patient has consented to participate by signing the Patient Informed Consent Form and/or has authorised the collection and release of his medical information by signing the patient Data release Consent form
3. The patient has presented with 12 hours of onset symptoms, and the clinical decision has been made to undergo primary PCI
4. Patient was suitable for implantation of one or more of the Endeavor ABT-578 Eluting Coronary Stent System, in one or more native artery target lesions
5. Lesion length and vessel diameter of the target lesion(s) are according to the Indications for Use that comes with every Endeavor ABT -578 Eluting Coronary Stent System
6. The patient is willing and able to cooperate with the registry procedures and required telephone contacts

Exclusion Criteria

1. Women with known pregnancy or who are lactating
2. Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacroloimus, sirolimus or similar drugs or any analogue or dervative, cobalt, chromium, nickel, molybdenum or contrast media
3. Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated
4. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon
5. Current medical condition with a life expectancy of less than 12 months
6. 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 enrolment in this trial. The subject may only be enrolled in this registry once.
7. Patients with medical conditions that preclude the follow up as defined in the protocol or that otherwise limits participation in this registry
8. Patients who are haemodynamically unstable (cardiogenic shock)
9. Patients who have a myocardial infarction in a non native coronary artery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac event at 30 days post PPCI

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac event at 6, 12 and 36 months.