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.
NCT06214819 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-04-28
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.
Conditions
Interventions
- DEVICE
-
VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
- DEVICE
-
XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion
XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion
Sponsors & Collaborators
-
Fundación EPIC
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-20
- Primary Completion
- 2026-07-01
- Completion
- 2026-08-31
Countries
- Spain
Study Locations
More Related Trials
-
Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions
NCT07190690 ·Status: RECRUITING ·Phase: NA
-
A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
NCT02579031 ·Status: COMPLETED ·Phase: NA
-
MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction
NCT03234348 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated With Bioresorbable and Metallic Stents at 1 Year
NCT02738658 ·Status: COMPLETED ·Phase: PHASE4
-
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)
NCT01078038 ·Status: COMPLETED ·Phase: PHASE4
-
OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation
NCT02504307 ·Status: COMPLETED ·Phase: PHASE4
-
The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.
NCT00233805 ·Status: COMPLETED ·Phase: PHASE2
-
SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent
NCT00917163 ·Status: TERMINATED ·Phase: PHASE4
-
Coroflex® ISAR NEO PMCF Study
NCT05698732 ·Status: RECRUITING
-
Sirolimus-Eluting Stent Versus Standard Stent in Diabetic
NCT00755443 ·Status: COMPLETED ·Phase: PHASE4
-
Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent
NCT02870140 ·Status: COMPLETED ·Phase: NA
-
Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
NCT02328898 ·Status: UNKNOWN ·Phase: PHASE4
-
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
NCT01171820 ·Status: COMPLETED ·Phase: PHASE4
-
Registry of RESOLUTE-ONYX™ Zotarolimus-eluting Stent Utilization in Percutaneous Small Vessel Coronary Interventionism.
NCT04785846 ·Status: COMPLETED
-
Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)
NCT01515228 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention
NCT03049657 ·Status: COMPLETED ·Phase: NA
-
A Registry Trial of The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
NCT04179045 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Clinical Evaluation of Patients With Everolimus-eluting Stent Xience V® Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period
NCT00882219 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)
NCT00233779 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice
NCT05981911 ·Status: RECRUITING
-
Functional Assessment of the Infart-related Artery With Bioactive and Polymer-free Coronary Stents (The FUNCOMBO Trial)
NCT04202172 ·Status: COMPLETED ·Phase: PHASE4
-
Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents
NCT01443104 ·Status: COMPLETED ·Phase: NA
-
Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis
NCT03151018 ·Status: UNKNOWN
-
Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)
NCT00140530 ·Status: COMPLETED ·Phase: PHASE4
-
Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease
NCT00192881 ·Status: UNKNOWN ·Phase: NA