Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

Study Overview
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Brief Summary
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Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

Detailed Description
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The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days. All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.

Official Title
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Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Angiography and Optical Coherence Tomography evaluations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤ 80years; Symptomatic CAD or documented myocardial ischemic disease; Up to 2 de novo lesions on native coronary arteries; Lesion length ≤ 29mm; Reference vessel diameter between ≥2.5 and ≤ 3.5 mm; Stenose at target lesion ≥ 70% and ≤ 99%. Exclusion Criteria: STEMI within the last 72 hours pre-procedure; renal insufficiency; Left Main stenosis > 50%; Ostial lesions; Bifurcation lesions with side branch ≥2mm; More than one lesion > 50% at the target vessel; Left Ejection Fraction less than 30%; Previous (less than 6 months) PCI at the target vessel.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 days evaluation<br>Angiography and Optical Coherence Tomography evaluations | Device: Angiography and Optical Coherence Tomography evaluations<br>* coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations<br>|
| Experimental: 2 months evaluation<br>Angiography and Optical Coherence Tomography evaluations | Device: Angiography and Optical Coherence Tomography evaluations<br>* coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations<br>|
| Experimental: 3 months evaluation<br>Angiography and Optical Coherence Tomography evaluations | Device: Angiography and Optical Coherence Tomography evaluations<br>* coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Coverage | Change in the tissue coverage percentage measured by OCT | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-stent late lumen loss | in-stent late lumen loss | 3 months | 
| Stent Thrombosis | Stent Thrombosis Rates | 2 years | 
| Target Vessel Failure | Target Vessel Failure (Death, MI and new revascularization) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, DES, INSPIRON, OCT, tissue repair