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

Primary Purpose

Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
DES "Calypso"
DES "Xience Prime"
Coronary angioplasty
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Calypso, Xience, Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • State Research Institute of CIrculation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sirolimus-eluting stent "Calypso"

Everolimus-eluting stent "Xience Prime"

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Target lesion failure
Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.

Secondary Outcome Measures

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.

Full Information

First Posted
January 19, 2016
Last Updated
December 14, 2017
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02681016
Brief Title
Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis
Keywords
Calypso, Xience, Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
610 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sirolimus-eluting stent "Calypso"
Arm Type
Experimental
Arm Description
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.
Arm Title
Everolimus-eluting stent "Xience Prime"
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
DES "Calypso"
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
DES "Xience Prime"
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Coronary angioplasty
Primary Outcome Measure Information:
Title
Target lesion failure
Description
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
Secondary Outcome Measure Information:
Title
1 year major adverse cardiac and cerebrovascular events (MACCE)
Description
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
Other Pre-specified Outcome Measures:
Title
Angiographic endpoint
Description
Estimation of target lesion late lumen loss in randomly selected 20% of the subjects.
Time Frame
1 year after procedure
Title
Device success
Description
Device success is defined as achievement of a final residual diameter stenosis 20% during the initial procedure.
Time Frame
procedure
Title
Lesion success
Description
Lesion success, defined as achievement of a final residual diameter stenosis 20% with use of any PCI approach.
Time Frame
procedure
Title
In-hospital procedure success
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE

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