Last updated: February 28, 2024
Sponsor: Hospital Universitario La Fe
Overall Status: Active - Recruiting
Phase
N/A
Condition
Thrombosis
Chest Pain
Heart Disease
Treatment
Predilation with conventional balloon
Predilation with cutting balloon.
Clinical Study ID
NCT05801003
529
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Symptomatic coronary artery disease or evidence of ischemia in the presence of one ormore coronary artery stenoses >50% in a native coronary artery.
Exclusion
Exclusion Criteria:
- Cardiogenic shock
- Patients presenting with ST-segment elevation myocardial infarction
- Patients undergoing chronic total occlusions PCI
- Patients undergoing left main PCI
- Patients undergoing venous bypass graft lesions PCI
- Patients with in-stent restenosis
- Inability to provide informed consent
- Life expectancy <1year due to non-cardiac disease
- Currently participating in another trial before reaching first endpoint There will be no exclusion based on mode of co-morbidities, left ventricular function,number of diseased vessels and lesions, or number of target lesions.
Study Design
Total Participants: 96
Treatment Group(s): 2
Primary Treatment: Predilation with conventional balloon
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
January 01, 2025
Study Description
Connect with a study center
Hospital de la Santa Creu i Sant Pau
Barcelona,
SpainSite Not Available
Hospital General de Valencia
Valencia,
SpainSite Not Available
Hospital Universitario y Politécnico La Fe
Valencia, 46026
SpainActive - Recruiting
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