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.
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Spain
Hospital Clinic Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall D'Hebron
RECRUITING
Barcelona
Hospital Universitario de Gerona Doctor Josep Trueta
RECRUITING
Girona
Hospital Universitari de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Contact Information
Primary
BRUNO GARCIA DEL BLANCO, MD, PhD
brunogb51@gmail.com
0034932746155
Backup
FUNDACION EPIC
iepic@fundacionepic.org
0034987876135
Time Frame
Start Date: 2024-03-20
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 40
Treatments
Experimental: VIVO ISAR DES in the first lesion
Active_comparator: XIENCE Skypoint DES in the first lesion
Related Therapeutic Areas
Sponsors
Leads: Fundación EPIC