Assessing plaque changes after drug-coated balloon treatment for coronary artery disease
Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention.
NA · Hospital Universitario La Fe · NCT06080919
This study is testing how a special balloon treatment for coronary artery disease affects plaque in the arteries and blood flow in patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario La Fe (other) |
| Locations | 1 site (Valencia) |
| Trial ID | NCT06080919 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of drug-coated balloon percutaneous coronary intervention (DCB-PCI) on plaque modification and coronary microcirculation in patients with coronary artery disease. It is a single-arm, open-label pilot study that will assess changes in atheroma volume using intravascular ultrasound (IVUS) before and after the procedure, as well as at a three-month follow-up. The study aims to provide insights into the healing processes and plaque remodeling associated with DCB-PCI, which could enhance understanding of this treatment's efficacy.
Who should consider this trial
Good fit: Ideal candidates are patients with coronary artery disease who are scheduled for percutaneous coronary intervention using drug-coated balloons.
Not a fit: Patients with severe coronary artery conditions, such as chronic total occlusions or those requiring mechanical support, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for coronary artery disease by providing evidence for the effectiveness of drug-coated balloons.
How similar studies have performed: Previous pilot studies have shown promising results with similar approaches, although this specific study is exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with coronary artery disease undergoing percutaneous coronary intervention with DCB. Exclusion Criteria: * 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.
Where this trial is running
Valencia
- Hospital Universitario y Politécnico La Fe — Valencia, Spain (RECRUITING)
Study contacts
- Study coordinator: Jorge Sanz Sanchez, MD, PhD
- Email: sjorge4@gmx.com
- Phone: 440087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Drug Coated-balloon, Intravascular Ultrasound, Plaque Modification, Percutaneous Coronary Intervention, Microvascular Coronary Artery Disease