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)
1 other identifier
interventional
610
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 19, 2016
CompletedFirst Posted
Study publicly available on registry
February 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedDecember 15, 2017
December 1, 2017
2.3 years
January 19, 2016
December 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
1 year major adverse cardiac and cerebrovascular events (MACCE)
during 1 year after procedure
Other Outcomes (4)
Angiographic endpoint
1 year after procedure
Device success
procedure
Lesion success
procedure
- +1 more other outcomes
Study Arms (2)
Sirolimus-eluting stent "Calypso"
EXPERIMENTALCommercially 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.
Everolimus-eluting stent "Xience Prime"
ACTIVE COMPARATORCommercially 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Research Institute of CIrculation Pathology
Novosibirsk, 630055, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2016
First Posted
February 12, 2016
Study Start
March 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
December 15, 2017
Record last verified: 2017-12