Plan to Evaluate Early Endothelialization of a Polymer Free Sirolimus-eluting Coronary Stent Syst… (NCT06214819) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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.
Spain40 participantsStarted 2024-03-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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)
What they're measuring
1
Percentage of early Covered struts (≥ 20μm) at 1 month OCT after stent implantation
Timeframe: 1 month
2
Percentage of stents with uncovered struts at 1 month OCT after stent implantation
Timeframe: 1 month
3
Mean thickness of struts tissue coverage at 1 month OCT after stent implantation