Status:
TERMINATED
Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty
Lead Sponsor:
Instituto Nacional de Cardiologia Ignacio Chavez
Conditions:
High Bleeding Risk
Coronary Artery Disease (CAD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients undergoing elective coronary percutaneous int...
Detailed Description
Drug Eluting Stents (DES) are the devices of choice for coronary angioplasty, including in patients with high-bleeding risk. Different studies have been done to determine which strategy improves blee...
Eligibility Criteria
Inclusion
- Patients 18 years old or older with an ischemic de-novo lesion(s) in a 2.5 - 4.0 mm reference diameter coronary artery suitable for elective 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 DEB or 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 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 while on DAPT
- Recent major surgery or major trauma within 30 days before PCI
- Minor Criteria:
- Age 75 years old and older
- Moderate Chronic Kidney Disease (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
- STEMI undergoing primary PCI
- Any ACS undergoing urgent PCI
- Cardiogenic shock or resuscitation with uncertain neurological status at arrival to PCI
- Unprotected left main lesion
- Life expectancy \< 12 months
- Reference vessel diameter \< 2.5 mm or \> 4.0 mm
- Bifurcation lesion requiring 2-stent technique
- Chronic total occlusion
- In-stent restenosis
- Dissection affecting the flow (TIMI\<3) or significant recoil (\>30% in main branch, \>50% in side branch) after predilatation
- Inability to give written consent
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04885816
Start Date
April 20 2021
End Date
September 29 2021
Last Update
October 26 2021
Active Locations (1)
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1
Instituto Nacional de Cardiologia "Ignacio Chávez"
Mexico City, Mexico, 14080