Coronary Artery Disease, Coronary Artery Stenosis, Coronary Atherosclerosis, Ischemic Heart Disease
Conditions
Keywords
Calypso, Xience, Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease
Brief summary
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)
Interventions
DEVICEDES Calypso
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.
DEVICEDES Xience Prime
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.
PROCEDURECoronary angioplasty
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction). * Target vessel lesion in coronary artery with diameter measurements \>2.5 mm & \< 4.5 mm. * Signed, documented informed consent prior to admission to the study
Exclusion criteria
* Age \<18 years or \>75 years * Renal insufficiency (GFR/MDRD \<30 ml/min) * Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3. * Known non-adherence to DAPT * LVEF \<30% * Known oncology * Severe cardiac valvular pathology, requiring operative treatment within 1 year * Anemia (HB\<100 g/l) * Continuing bleeding * Acute coronary syndrome (ST-elevation Myocardial infarction) * Anamnesis of previous coronary angioplasty/stenting or CABG * NYHA class (dyspnoea) IV or hospitalization during last year due to Chronic cardiac failure as a primary diagnosis. * Pregnancy * Coronary pathology requiring CABG or staged scheduled coronary angioplasty/stenting except cases of unscheduled staged coronary angioplasty/stenting within 4 weeks after primary procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | during 1 year after procedure | Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1 year major adverse cardiac and cerebrovascular events (MACCE) | during 1 year after procedure | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Angiographic endpoint | 1 year after procedure | Estimation of target lesion late lumen loss in randomly selected 20% of the subjects. |
| Device success | procedure | Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure. |
| Lesion success | procedure | Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any PCI approach. |
| In-hospital procedure success | Within 5-day hospitalization | 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. |
Countries
Russia
Outcome results
None listed