N/A
Completed N=1,402
The Medtronic RESOLUTE US Clinical Trial
Source: ClinicalTrials.gov NCT00726453 ↗Enrolled (actual)
1,402
Serious AEs
38.3%
Results posted
May 2012
Primary outcomePrimary: Target Lesion Failure (TLF) — 4.7 percentage of participants
Summary
The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Lesion Failure (TLF) |
4.7 | — |
| SECONDARY Target Vessel Failure (TVF) |
6.3 | — |
| SECONDARY Major Adverse Cardiac Event (MACE) |
5.5 | — |
| SECONDARY Death |
1.3 | — |
| SECONDARY Target Vessel MI |
1.4 | — |
| SECONDARY Stent Thrombosis (ST) |
0.1 | — |
Eligibility Criteria
General and Angiographic Inclusion Criteria highlights:
- Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
- Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
- Informed consent
- Patient agrees to comply with specified follow-up evaluations at same investigational site
- Single target lesion or two target lesions located in separate coronary arteries
- De novo lesion(s) in native coronary artery(ies)
- Target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent)
- Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent)
General and Angiographic Exclusion Criteria highlights:
- Within 7 days of implant platelet count 700,000 cells/mm³; WBC count 2.5 mg/dl
- Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB > lab upper limit of normal)
- Previous PCI of target vessel(s) within 9 months prior to the procedure
- Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
- History of stroke or TIA within prior 6 months
- Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
- Inability to comply with required trial antiplatelet regimen
- Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
- Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
- Unprotected left main coronary artery disease
Data sourced from ClinicalTrials.gov (NCT00726453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.