Endeavor primary percutaneous coronary intervention (PCI) study
| ISRCTN | ISRCTN66301072 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66301072 |
| Secondary identifying numbers | 4963 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 22/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Greenwood
Scientific
Scientific
Academic Unit of Cardiovascular Medicine
Great George Street
Leeds
LS1 3EX
United Kingdom
Study information
| Study design | Non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Leeds (West) Research Ethics Committee approved on the 7th September 2006 (ref: 06/Q1205/171) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 21/08/2006 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/08/2006 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Unit of Cardiovascular Medicine
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Medtronic Ltd (UK)
Industry
Industry
Building 9
Crossley Green Business Park
Watford
WD18 8WW
United Kingdom
| Website | http://www.medtronic.co.uk/about-medtronic/medtronic-uk/index.htm |
|---|---|
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
Medtronic PLC (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2011 | Yes | No |
