The Medtronic RESOLUTE US Clinical Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2008 |
| End Date: | June 2016 |
A Clinical Evaluation of the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2mm
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.
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.
The trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the
2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients),
and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is
dependent on the size (diameter or length) of the stent(s) the patient receives.
2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients),
and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is
dependent on the size (diameter or length) of the stent(s) the patient receives.
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 <100,000 cells/mm³ or >700,000 cells/mm³; WBC
count <3,000 cells/mm³; serum creatinine level >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
We found this trial at
1
site
Click here to add this to my saved trials
