Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE

Coronary Artery Disease Clinical Trial

— PATRIOT  

Official title:

Prospective rAndomized, Single-blind, multicenTral Control Clinical Trial of Sirolimus-eluting coRonary Stent "Calypso" (Angioline) vs Everolimus-elutIng cOronary stenT "Xience Prime" (Abbott Vascular)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681016
• Other study ID #: PAT1.0
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: December 14, 2017
• Start date: March 2015
• Est. completion date: July 2017

Study information

• Verified date: December 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Atherosclerosis
• Coronary Disease
• Coronary Stenosis
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• DES "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.
• DES "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.

Procedure:
• Coronary angioplasty

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Angiographic endpoint	Estimation of target lesion late lumen loss in randomly selected 20% of the subjects.	1 year after procedure
Other	Device success	Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.	procedure
Other	Lesion success	Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any PCI approach.	procedure
Other	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.	Within 5-day hospitalization
Primary	Target lesion failure	Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.	during 1 year after procedure
Secondary	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.	during 1 year after procedure