N/A
N=230
An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01638507 ↗Enrolled (actual)
230
Serious AEs
38.3%
Results posted
Nov 2015
Primary outcome: Primary: Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) — 3.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resolute Integrity Stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Vascular
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) |
3.6 | — |
| SECONDARY Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI |
15.0 | — |
| SECONDARY Clinical Endpoint: Death |
1.8 | — |
| SECONDARY Dual Antiplatelet Therapy (DAPT) Compliance |
89.2 | — |
| SECONDARY Clinical Endpoint: TLR |
2.3 | — |
| SECONDARY Clinical Endpoint: TVR |
4.5 | — |
| SECONDARY Clinical Endpoint: MI |
2.7 | — |
| SECONDARY Clinical Endpoint: ST |
0.9 | — |
| SECONDARY Clinical Endpoint: Stroke |
0.5 | — |
| SECONDARY Clinical Endpoint: Bleeding Complications in General |
11.4 | — |
Summary
The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
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
- 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
- Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm
General and Angiographic Exclusion Criteria highlights:
- Within 7 days of index procedure platelet count 700,000 cells/mm³; White Blood Cell (WBC) count 2.5 mg/dl
- Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (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 Transient Ischemic Attack (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 (NCT01638507). 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.