The Medtronic RESOLUTE Clinical Trial

Coronary Artery Disease Clinical Trial

Official title:

The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248079
• Other study ID #: IP069
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 2005
• Last updated: October 18, 2011
• Start date: November 2005
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Health Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 2011
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coronary Artery Stenting
Initial implant of drug eluting stent (zotarolimus)

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)		9 months	No
Secondary	Major adverse cardiac event (MACE) rate		30 days, 4, 6, 9 & 12 months	Yes
Secondary	Acute success (device, lesion, and procedure)		4 or 9 Months	No
Secondary	Target vessel failure (TVF)		9 months	Yes
Secondary	Target lesion revascularization (TLR)		9 months	Yes
Secondary	Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS)		4 or 9 months	No
Secondary	Pharmacokinetic parameters		last measurement at 60 days	No
Secondary	Angiographic parameters (in-stent and in-segment)		4 or 9 months	No