Coronary Artery Disease
Conditions
Keywords
Drug-eluting stent, OCT, Re-endothelialization
Brief summary
The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent
Detailed description
The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent
Interventions
DEVICECoroflex® ISAR Drug-eluting stent
Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.
DEVICEUltimaster® Drug-eluting stent
Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.
Sponsors
B.Braun Surgical SA
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 18 years * Signature of informed consent * Patients with angina and a clinical indication for coronary revascularisation with a drug-eluting stent * Presence of at least 2 lesions to be revascularised with similar angiographic characteristics * Reference lesion diameter with at most a difference of 0.5 mm * Maximum difference in lesion length of 10 mm * Lesions able to be treated with only 1 stent
Exclusion criteria
* Lesions due to restenosis * Lesions in saphenous vein grafts * STE-ACS ( ST elevation- Acute Coronary Syndrome) * Cardiogenic shock * Dual antiplatelet therapy contraindication for\> 3 months * Follow-up catheterisation contraindicated * Chronic kidney failure with creatinine \> 2 mg/dL * Allergy to iodinated contrast agents * Serious complication from vascular access in previous catheterisation * Ineligible for evaluation via optical coherence tomography * Lesion located \<5 mm from aorto-ostial junction * Severe proximal angulation \>90º * Bifurcation lesion requiring a strategy with two stents * Angiographic characteristics that promote stent malposition * Aneurysm or coronary artery ectasia * Presence of a thrombus classed as TIMI (Thrombolysis In Myocardial Infarction )2 flow or higher * Severe calcification, in particular in cases of calcium spike * Severe lesion angulation * Inability to do reliable follow-up, in the investigator's opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation. | 3 months |
| Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation. | 3 months |
| Percentage of covered struts at 3 months OCT after stent implantation. | 3 months |
| Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation. | 3 months |
| Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of stent malapposition at 1 month and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Percentage of struts malapposition at 1 month and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Percentage of covered struts, at 1 month, 2 months and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Percentage of stents with any malapposition strut > 260 µm at 1 month and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Healing Score at 1 month and 3 months OCT after stent implantation . | 1 month and 2 months and 3 months |
| Percentage of struts malapposition> 260 µm at 1 month and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Total Tissue coverage at 1month, 2 months and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| Mean thickness of struts tissue coverage at 1 month, 2 months and 3 months OCT after stent implantation. | 1 month and 2 months and 3 months |
| MACE (Major Adverse Cardiac Events) at 30 days, 3 months, 6 months and 12 months. | 30 days and 3 months and 6 months and 12 months |
| Target lesion revascularization and target vessel revascularization at 30 days, 3 months, 6 months and 12 months OCT after stent implantation . | 30 days and 3 months and 6 months and 12 months |
Countries
Spain
Outcome results
None listed