Resolute Integrity US Extended Length Sub-Study(RI US XL)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/4/2018 |
| Start Date: | July 2013 |
| End Date: | October 2020 |
Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity 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 4.2 mm
Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety
and efficacy of the Resolute Integrity Stent 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 in patients who
receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.
and efficacy of the Resolute Integrity Stent 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 in patients who
receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.
The purpose of this postapproval study is to conduct a prospective, multi-center evaluation
of the procedural and clinical outcomes of subjects that are treated with the commercially
available 34 mm and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent
System.
Descriptive statistics and 95% confidence intervals will be calculated for clinically
relevant variables as described in a separate statistical analysis plan.
of the procedural and clinical outcomes of subjects that are treated with the commercially
available 34 mm and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent
System.
Descriptive statistics and 95% confidence intervals will be calculated for clinically
relevant variables as described in a separate statistical analysis plan.
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) ≤ 35 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 <100,000 cells/mm³ or >700,000
cells/mm³; White blood cell (WBC) count <3,000 cells/mm³; serum creatinine level >2.5
mg/dl
- Acute Myocardial Infarction (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
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