Evaluating new methods for assessing coronary artery disease after procedures
Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients
This study is testing a new way to check for coronary artery disease in patients with multiple blocked arteries to see if it works better than the usual method after they have heart procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 4 sites (Alicante and 3 other locations) |
| Trial ID | NCT06273293 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of using a new method called cFFR-NTG for assessing coronary artery disease in patients with multivessel conditions. It aims to improve the management of intermediate coronary lesions by comparing this method to the traditional fractional flow reserve (FFR) technique, which often requires adenosine. The study will involve patients undergoing percutaneous coronary intervention (PCI) and will utilize a specialized pressure microcatheter for both diagnosis and post-procedure evaluation. By focusing on patients with significant stenosis in multiple vessels, the trial seeks to enhance therapeutic decision-making and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with multivessel coronary artery disease requiring percutaneous coronary revascularization.
Not a fit: Patients with contraindications to adenosine or significant comorbidities limiting life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of coronary artery disease and reduced risk of future cardiovascular events for patients.
How similar studies have performed: Other studies have shown promise with similar approaches, particularly in improving outcomes for patients with coronary artery disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>18 years old and, * Patients with multivessel coronary artery disease (multivessel coronary artery disease will be considered the presence of significant stenosis in 2 or more first or second order vessels greater than 1.5 mm in diameter with an angiographic reduction of their diameter ≥50% by visual estimation) subsidiary of percutaneous coronary revascularization in at least one of them and, * Use of Navvus pressure microcatheter both for functional diagnosis and for post-PCI evaluation of the different vessels and, * Patients who have signed the Informed Consent. Exclusion Criteria: * Patients with intolerance or contraindication to adenosine. * Hemodynamically unstable patients, acute phase of a STEACS. * Patient with significant comorbidity with limited life expectancy. * Patients with the patient's express refusal to participate in the study. * Pregnant or breastfeeding female patients.
Where this trial is running
Alicante and 3 other locations
- Hospital Universitario San Juan de Alicante — Alicante, Spain (Recruiting)
- Hospital Universitario de Badajoz — Badajoz, Spain (Recruiting)
- Hospital Universitario Juan Ramón Jiménez — Huelva, Spain (Recruiting)
- Hospital Universitario Virgen del Rocío — Seville, Spain (Recruiting)
Study contacts
- Study coordinator: SANTIAGO J CAMACHO FREIRE, MD, PhD
- Email: hemodinamica.cardiologia.huelva@gmail.com
- Phone: 0034677981941
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.