Status:
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.
Lead Sponsor:
Fundación EPIC
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) implant...
Detailed Description
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) implant...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06214819
Start Date
March 20 2024
End Date
January 31 2026
Last Update
January 2 2026
Active Locations (4)
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1
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
2
Hospital Clinic Barcelona
Barcelona, Spain, 08036
3
Hospital Universitario de Gerona Doctor Josep Trueta
Girona, Spain, 17007
4
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain, 08907