Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE (PATRIOT)

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

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)

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Stenosis
• Intervention / Treatment: Device: DES "Calypso"; Procedure: Coronary angioplasty; Device: DES "Xience Prime"

• Study Type: Interventional
• Enrollment (Actual): 610
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • State Research Institute of Circulation Pathology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sirolimus-eluting stent "Calypso"; 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"; 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
Active Comparator: Everolimus-eluting stent "Xience Prime"; 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.	Procedure: Coronary angioplasty; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic endpoint	Estimation of target lesion late lumen loss in randomly selected 20% of the subjects.	1 year after procedure
Device success	Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.	procedure
Lesion success	Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any PCI approach.	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.	Within 5-day hospitalization

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Ischemic Heart Disease; Calypso; Drug-eluting stent; Coronary stenosis; Coronary angioplasty with stenting; Xience
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Coronary Stenosis
• Other Study ID Numbers: PAT1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided