Intra-patient Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT (Optical Coherence Tomography) Follow up

Study Overview
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Brief Summary
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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
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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

Official Title
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Intra-patient Randomized Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT Follow up

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Coroflex® ISAR Drug-eluting stent
* Device: Ultimaster® Drug-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coroflex® ISAR Drug-eluting stent in first lesion<br>Patients with Coroflex® ISAR Drug-eluting stent in the first lesion | Device: Coroflex® ISAR Drug-eluting stent<br>* Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.<br>|
| Active Comparator: Ultimaster® Drug-eluting stent in first lesion<br>Patients with Ultimaster® Drug-eluting stent in first lesion | Device: Ultimaster® Drug-eluting stent<br>* Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.<br>|
| Active Comparator: Coroflex® ISAR Drug-eluting stent in second lesion<br>Patients with with Ultimaster® Drug-eluting stent in first lesion | Device: Coroflex® ISAR Drug-eluting stent<br>* Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.<br>|
| Active Comparator: Ultimaster® Drug-eluting stent in second lesion<br>Patients with Coroflex® ISAR Drug-eluting stent in the first lesion | Device: Ultimaster® Drug-eluting stent<br>* Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 stents with ≥3% of uncovered 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of covered struts, at 1 month, 2 months 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 | 
| 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 struts malapposition> 260 µm at 1 month 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting stent, OCT, Re-endothelialization