VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
DeviceVIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
NCT Number: NCT06214819
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hospital Clinic Barcelona, Barcelona, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
VIVO ISAR DES implanted in the First lesion, XIENCE Skypoint DES implanted in the Second lesion
XIENCE Skypoint DES implanted in the First lesion, VIVO ISAR DES implanted in the Second lesion
Time frame: 1 month
Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation
Time frame: 1 month
Percentage of stents with uncovered struts (0μm) at 1 month OCT after stent implantation
Time frame: 1 month
Mean thickness of struts tissue coverage at 1 month OCT after stent implantation
Time frame: 1 month
Percentage of malapposition of stent at 1 month OCT after stent implantation
Time frame: 1 month
Percentage of covered struts at 1 months OCT after stent implantation
Time frame: 6 months
All-Cause Death Rate at 6 months
Time frame: 6 months
Cardiac Death Rate at 6 months
Time frame: 6 months
Myocardial Infarction Rate at 6 months
Time frame: 6 months
Target vessel revascularization Rate at 6 months
Time frame: 1 months
The NHS is then calculated as follows:
Time frame: 1 month
Percentage of malapposed total struts at 1 month
Time frame: 1 month
Strut malapposition: Measured maximum distance ≥100 μm between the strut surface and adjacent vessel surface by OCT, considering thickness of scaffold, was defined as malapposition. As a result, scaffold malapposition is defined as the presence of any malapposed struts. The ratio of malapposed struts (% malapposed strut) was the ratio of malapposed struts from total analyzable struts.
Fundación EPIC
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05755711
Arterial Occlusive Diseases, Arteriosclerosis
Loma Linda, California, United States
View Trial DetailsNCT06885177
Arterial Occlusive Diseases, Arteriosclerosis
Scottsdale, Arizona, United States
View Trial DetailsNCT04763200
Anterior Wall Myocardial Infarction, Arterial Occlusive Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT04470934
Arterial Occlusive Diseases, Arteriosclerosis
Jena, Thuringia, Germany
View Trial Details