An interventional study of DES "Calypso" and DES "Xience Prime" in Ischemic Heart Disease, Coronary Atherosclerosis and Coronary Artery Disease, sponsored by Meshalkin Research Institute of Pathology of Circulation. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-15.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Not applicable, Interventional, and Treatment
The aim of the study is to evaluate the efficacy and safety of sirolimus-eluting coronary stent "Calypso" (Angioline, Russia) in comparison with everolimus-eluting coronary stent "Xience" (Abbott Vascular, USA)
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 610 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 114 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Commercially approved coronary stent system "Calypso" (Angioline, Russia) Coating - Sirolimus(rapamicine) Stent diameters: 2.0, 2.25, 2.5, 2.75, 3.0, 3.5, 4.0, 4.5 mm. Stent lengths: 8, 13, 15, 18, 23, 28, 33, 38 mm.
Device: DES "Calypso" · Procedure: Coronary angioplasty
Commercially approved XIENCE PRIME, (Abbott Vascular, USA) Coating - Everolimus with concentration Stent diameters: 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm. Stent lengths: 8, 12, 15, 18, 23, 28, 33, 38 mm.
Device: DES "Xience Prime" · Procedure: Coronary angioplasty
A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Stenosis of coronary artery is passed by the hydrophilic coronary wire. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.
A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Stenosis of coronary artery is passed by the hydrophilic coronary wire. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.
Target lesion failure
Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.
Time frame: during 1 year after procedure
1 year major adverse cardiac and cerebrovascular events (MACCE)
1 year major adverse cardiac and cerebrovascular events (MACCE) including: All-cause mortality, Myocardial infarction, Stroke, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.
Time frame: during 1 year after procedure
Angiographic endpoint
Estimation of target lesion late lumen loss in randomly selected 20% of the subjects.
Time frame: 1 year after procedure
Device success
Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.
Time frame: procedure
Lesion success
Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any PCI approach.
Time frame: procedure
In-hospital procedure success
Procedure success is defined as achievement of a final residual diameter stenosis 20% together with the absence of any in-hospital major adverse cardiac event. The 5-day hospitalization time frame was evaluated according to the standards of health care in patients was coronary angioplasty in Russia.
Time frame: Within 5-day hospitalization
Plan to share: Undecided
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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Meshalkin Research Institute of Pathology of Circulation