Condition category
Circulatory System
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
22/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Greenwood

ORCID ID

Contact details

Academic Unit of Cardiovascular Medicine
Great George Street
Leeds
LS1 3EX
United Kingdom

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 measures

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

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21883474

Publication citations

  1. 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.

Additional files

Editorial Notes