Status:
UNKNOWN
Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI).
Lead Sponsor:
Hospital Universitario La Fe
Conditions:
Coronary Artery Disease
Drug Coated-balloon
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Coronary artery disease (CAD) is one of the most common causes of mortality worldwide. Despite drug eluting stents (DES) are the most common treatment strategy, drug-coated balloons (DCB) represent an...
Detailed Description
The study will be an investigator-initiated, single-arm, open-label, pilot study in patients undergoing PCI with DCB for the novo lesion. Because of the exploratory nature of this study, no formal sa...
Eligibility Criteria
Inclusion
- Patient with coronary artery disease undergoing percutaneous coronary intervention with DCB.
Exclusion
- Aged \< 18 years.
- Cardiogenic shock.
- ST-segment elevation myocardial infarction.
- Use of mechanical circulatory support.
- Chronic total occlusions, bifurcation lesions, left main coronary artery disease, severe calcified lesions, graft interventions and in-stent restenosis.
- Inability to provide informed consent.
- Unable to understand and follow study-related instructions or unable to comply with study protocol.
- Currently participating in another trial.
- Pregnant women.
Key Trial Info
Start Date :
September 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06080919
Start Date
September 12 2022
End Date
May 1 2024
Last Update
October 23 2023
Active Locations (1)
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1
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026