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Endeavor primary percutaneous coronary intervention (PCI) study

Evaluation of the clinical performance of the Medtronic Endeavor ABT-578 eluting coronary stent system in patients undrgoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66301072
Enrollment
100
Registered
2010-04-23
Start date
2006-08-21
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular

Interventions

Consecutive patients presenting with an STEMI within 12 hours of onset of symptoms when the clinical decision was to undergo Primary PCI, were invited to participate. All subjects received one or more

Sponsors

Medtronic Ltd (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Major adverse cardiac event at 30 days post PPCI

Secondary

MeasureTime frame
Major adverse cardiac event at 6, 12 and 36 months.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026