Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk (ZEVS-HBR)

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    280
  • sponsor
    Instituto Nacional de Cardiologia Ignacio Chavez
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Updated on 15 March 2022
See if I qualify
angiography
aspirin
cancer
stroke
sirolimus
percutaneous coronary intervention
antiplatelet therapy
ischemia
dapt
bypass graft
zotarolimus

Summary

Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients who underwent elective coronary percutaneous intervention with a zotarolimus eluting stent versus a sirolimus eluting stent and short Dual Antiplatelet Therapy (DAPT).

Details
Condition High Bleeding Risk, Coronary Artery Disease, Percutaneous Coronary Intervention
Treatment Zotarolimus eluting stent, Sirolimus eluting stent
Clinical Study IdentifierNCT05240781
SponsorInstituto Nacional de Cardiologia Ignacio Chavez
Last Modified on15 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients 18 years old or older with an ischemic de-novo lesion(s) in coronary artery or
coronary bypass graft suitable for percutaneous coronary intervention, in context of acute
coronary syndrome or chronic coronary syndrome with evidence of ischemia by non-invasive
study or pressure guidewire that can be treated by DES, and has at least 1 major or 2 minor
Academic Research Consortium High Bleeding Risk criteria
Major criteria
Anticipated use of long-term oral anticoagulation
Severe or end-stage Chronic Kidney Disease (CKD) (eGFR <30 mL/min)
Hemoglobin < 11 g/dL
Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months
or any time, if recurrent
Moderate or severe baseline thrombocytopenia (<100,000/uL)
Chronic bleeding diathesis
Liver cirrhosis with portal hypertension
Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months
Previous spontaneous intracranial hemorrhage
Previous traumatic intracranial hemorrhage within the past 12 months
Presence of Brain Arteriovenous malformation (AVM)
Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the
past 6 months
Non-deferrable major surgery on DAPT
Recent major surgery or major trauma within 30 days before PCI
Minor Criteria
Age 75 years old and older
Moderate CKD (eGFR 30-59 mL/min)
Hemoglobin 11 - 12.9 g/dL in men and 11 - 11.9 g/dL in women
Spontaneous bleeding requiring hospitalization or transfusion within the past 12
months, not meeting major criterion
Long term use of NSAIDs or steroids
Any ischemic stroke at any time not meeting major criterion

Exclusion Criteria

STEMI undergoing primary PCI
Cardiogenic shock or resuscitation with uncertain neurological status at arrival to
PCI
Unprotected left main lesion
Reference diameter larger or shorter than available stents
Life expectancy < 12 months
In-stent restenosis o thrombosis of previous stent
Inability to give written consent
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