NCT06214819Active, not recruiting
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.
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.
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
To evaluate the stent endothelialization (\> 20 microns) of VIVO ISARTM versus XIENCE SkypointTM stents at 1-month (very early strut covered) at follow-up by Optical Coherence Tomography (OCT) implanted IN THE SAME PATIENT during routine clinical practice.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 13 Dec 2023
- Start date
- 20 Mar 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Fundación EPIC
- Diseases
- Coronary artery disease
- NCT number
- NCT06214819
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 20 Mar 2024 to the primary completion date, 1 Jul 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with PCI in the target vessel in the previous 9 months
Other illness
- Patients with ST elevation Myocardial Infarction or Cardiogenic Shock
- Patients with malignant neoplasms or other comorbid conditions with life expectancy \<12 months
- Patients with contraindication or difficulty to evaluate in the follow-up with OCT (renal failure, excessive tortuosity or lesions aorto-ostial)
Lab values
- Severe calcified lesion (need to use prior complex techniques of calcium modification such as intravascular lithotripsy, rotational/orbital atherectomy, laser.
Other
- Express refusal of the patient to participate in the study
- 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 .
- Patients with a target lesion in a bypass graft
- Lesions due to restenosis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario de Gerona Doctor Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.