Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4963
Study information
Scientific title
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
Acronym
Study hypothesis
Primary percutaneous coronary intervention (PPCI) is superior to thrombolysis in patients with ST elevation acute myocardial infarction (STEMI). Furthermore, drug eluting stents (DES) have been shown to be superior to bare metal stents (BMS) for reduction in clinical restenosis rates. Data on late stent thrombosis (greater than 30 days) raise concerns about DES placement in a patient with an acute coronary syndrome. Recent studies using sirolimus and paclitaxel-eluting stents in the PPCI setting have been published and suggestequivalence or superior outcomes compared to BMS. We aim to evaluate the Medtronic Endeavor ABT-578 eluting coronary stent system in patients undergoing PPCI.
Ethics approval
Leeds (West) Research Ethics Committee approved on the 7th September 2006 (ref: 06/Q1205/171)
Study design
Non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention
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 Medtronic Endeavor ABT-578 eluting coronary stent in one or more target lesions. All subjects to be followed for 3 years.
Intervention type
Drug
Phase
Not Applicable
Drug names
ABT-578
Primary outcome measure
Major adverse cardiac event at 30 days post PPCI
Secondary outcome measures
Major adverse cardiac event at 6, 12 and 36 months.
Overall trial start date
21/08/2006
Overall trial end date
01/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100
Participant 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
Recruitment start date
21/08/2006
Recruitment end date
01/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Unit of Cardiovascular Medicine
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Medtronic Ltd (UK)
Sponsor details
Building 9
Crossley Green Business Park
Watford
WD18 8WW
United Kingdom
Sponsor type
Industry
Website
http://www.medtronic.co.uk/about-medtronic/medtronic-uk/index.htm
Funders
Funder type
Industry
Funder name
Medtronic PLC (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21883474
Publication citations
-
Results
Shelton RJ, Chitkara K, Singh R, Dorsch MF, Somers K, McLenachan JM, Blaxill JM, Wheatcroft SB, Blackman DJ, Greenwood JP, Three-year clinical outcome with the Endeavor™ zotarolimus-eluting stent in primary percutaneous coronary intervention for ST elevation myocardial infarction: the Endeavor™ primary PCI study (E-PPCI)., J Interv Cardiol, 2011, 24, 6, 542-548, doi: 10.1111/j.1540-8183.2011.00674.x.