Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00248079




Registration number
NCT00248079
Ethics application status
Date submitted
1/11/2005
Date registered
3/11/2005
Date last updated
20/10/2011

Titles & IDs
Public title
The Medtronic RESOLUTE Clinical Trial
Scientific title
The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Secondary ID [1] 0 0
IP069
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Coronary Artery Stenting

Treatment: Devices: Coronary Artery Stenting
Initial implant of drug eluting stent (zotarolimus)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
Major adverse cardiac event (MACE) rate
Timepoint [1] 0 0
30 days, 4, 6, 9 & 12 months
Secondary outcome [2] 0 0
Acute success (device, lesion, and procedure)
Timepoint [2] 0 0
4 or 9 Months
Secondary outcome [3] 0 0
Target vessel failure (TVF)
Timepoint [3] 0 0
9 months
Secondary outcome [4] 0 0
Target lesion revascularization (TLR)
Timepoint [4] 0 0
9 months
Secondary outcome [5] 0 0
Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS)
Timepoint [5] 0 0
4 or 9 months
Secondary outcome [6] 0 0
Pharmacokinetic parameters
Timepoint [6] 0 0
last measurement at 60 days
Secondary outcome [7] 0 0
Angiographic parameters (in-stent and in-segment)
Timepoint [7] 0 0
4 or 9 months

Eligibility
Key inclusion criteria
1. Patient is at least 18 years old
2. Patient is an acceptable candidate for percutaneous coronary intervention and emergent coronary artery bypass graft surgery
3. Patient has clinical evidence of ischemic heart disease or a positive functional study
4. Female patients of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
5. Patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by Human Research Ethics Committee of the respective investigational site
6. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed. Patients participating in the PK sub-study must agree to the additional follow-up procedures as required by the sub-study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coating components or a sensitivity to contrast media, which cannot be adequately pre-medicated
2. History of an allergic reaction or significant sensitivity to drugs such as ABT-578, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
3. Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³
4. Serum creatinine level > 170 micromol/L within 7 days prior to index procedure
5. Evidence of an acute myocardial infarction within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction or non-Q wave myocardial infarction having CK enzymes > 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal))
6. Previous stenting anywhere in the target vessel
7. PCI of the target vessel within 30 days prior to the procedure
8. Implantation of a drug eluting stent in any non-target vessel within 30 days prior to the procedure. Implantation of a Cypher stent in any non-target vessel within 90 days prior to the procedure
9. PCI of a non-target vessel with a bare metal stent within 30 days prior to the procedure that results in any MACE event. If the bare metal stent is implanted within 72 hours prior to the procedure, a post procedural serial CK or CK-MB measurement above the investigational site's upper limit of normal (two below upper normal required for enrollment)
10. PCI of a non-target vessel within 24 hours prior to the procedure
11. Planned PCI of any vessel within 30 days post-procedure. Planned stenting of any vessel with a Cypher or Endeavor stent within 60 days post-procedure
12. Planned PCI of the target vessel within 9 months post-procedure
13. During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement
14. History of a stroke or transient ischemic attack within the prior 6 months
15. Active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months
16. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
17. Concurrent medical condition with a life expectancy of less than 12 months
18. Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy
19. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures
20. Documented left ventricular ejection fraction < 30% at the most recent evaluation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Meredith, Professor
Address 0 0
Monash Medical Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00248079