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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/Phase 2
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
To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute
Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in
native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in
diameter.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00248079
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00248079