Comparing two types of drug-eluting stents for coronary artery disease treatment
Randomized, Controlled, Open-label, Double-blind, Multicenter Investigation Plan to Evaluate Early Endothelialization of a Polymer Free Sirolimus-eluting Coronary Stent System (VIVO ISARTM) Compared With Everolimus-eluting Durable Polymer Stent (XIENCE SkypointTM) in Patients Undergoing Percutaneous Coronary Intervention.
This study is testing two different drug-coated stents to see which one helps patients with coronary artery disease heal better after heart procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 4 sites (Barcelona and 3 other locations) |
| Trial ID | NCT06214819 on ClinicalTrials.gov |
What this trial studies
This study evaluates the early endothelialization of two different drug-eluting stents, VIVO ISARTM and XIENCE SkypointTM, in patients undergoing percutaneous coronary intervention. The stents will be implanted in the same patient, allowing for a direct comparison of their performance at one month post-implantation using Optical Coherence Tomography (OCT). The goal is to determine which stent achieves better strut coverage, which is crucial for long-term success in treating coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with coronary artery disease requiring stenting for de novo lesions in major coronary arteries.
Not a fit: Patients with complex coronary interventions or those experiencing acute myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients with coronary artery disease by identifying a stent that promotes faster healing.
How similar studies have performed: Other studies have shown promising results with similar drug-eluting stent comparisons, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with age ≥ 18 years AND * Patients who have signed informed consent AND * Patients with coronary artery disease requiring percutaneous treatment with coronary stents due to de novo lesions in vessels with a diameter of reference from 2.25 mm to 4.0 mm AND * Patients with at least 2 angiographic lesions in 2 different major coronary arteries. Or in the main branch and in one of its subsidiaries branches , as long as those are not "downstream" of the lesion from the main branch Exclusion Criteria: * Express refusal of the patient to participate in the study * Patients with ST elevation Myocardial Infarction or Cardiogenic Shock * Patients with high thrombotic content * Pregnant or breastfeeding patients * Patients with complex PCI (Percutaneous Coronary Intervention )(defined as): * Left main PC * Chronic total PC occlusion * Bifurcation lesion requiring 2-stent technique . * Severe calcified lesion (need to use prior complex techniques of calcium modification such as intravascular lithotripsy, rotational/orbital atherectomy, laser. * Patients with malignant neoplasms or other comorbid conditions with life expectancy \<12 months * Patients with a target lesion in a bypass graft * Lesions due to restenosis * Patients with PCI in the target vessel in the previous 9 months * Patients with contraindication or difficulty to evaluate in the follow-up with OCT (renal failure, excessive tortuosity or lesions aorto-ostial)
Where this trial is running
Barcelona and 3 other locations
- Hospital Universitari Vall D'Hebron — Barcelona, Spain (Recruiting)
- Hospital Clinic Barcelona — Barcelona, Spain (Recruiting)
- Hospital Universitario de Gerona Doctor Josep Trueta — Girona, Spain (Recruiting)
- Hospital Universitari de Bellvitge — Hospitalet de Llobregat, Spain (Recruiting)
Study contacts
- Study coordinator: BRUNO GARCIA DEL BLANCO, MD, PhD
- Email: brunogb51@gmail.com
- Phone: 0034932746155
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.