Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis

Study Overview
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Brief Summary
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The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular Scaffolds (Abbott Vascular) remains a challenge. This study will assess the incidence, predisposing factors, pathophysiology and prognosis of the patient in this setting.

Detailed Description
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Treatment of patients with ISR remains a challenge. Currently both drug-eluting stents (DES) and drug-coated balloons (DCB) are considered as the strategies of choice in this setting. However, existing data about ISR of BVS are scarce (isolated cases and retrospective series with very few patients) on the incidence, predisposing factors, pathophysiology, treatment, and long-term prognosis of these patients. In this sense, a prospective Spanish registry of patients with ISR of DVB can obtain a very relevant clinical information that allows us to advance in our knowledge about this phenomenon that helps to prevent it and to treat it in the safest and most effective way possible. Clinical events will be adjudicated by an independent Clinical Event Committee.

Official Title
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Observational Study of Treatment of Bioresorbable Vascular Scaffolds Restenosis

Conditions
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Coronary In-stnent Restenosis

Intervention / Treatment
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* Device: Treatment of restenosis


Participation Criteria
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Eligibility Criteria
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In-stent restenosis of BVS with ischemia. Signed Informed Consent IRB approval. INCLUSION CRITERIA: PATIENT Age > 20 and < 85 years of age Angina or objective evidence of ischemia LESION ISR (>50% diameter stenosis on visual assessment) Previous stent location known EXCLUSION CRITERIA: PATIENT Inclusion in other clinical research protocol Refuse to sign Informed Consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BVS restenosis<br>Patients with a Bioresorbable Vascular Scaffold Restenosis | Device: Treatment of restenosis<br>* Treatment of in-stent restenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization) | This is a well-accepted outcome measure of individual clinical end-points. Definition of myocardial infarction is similar to that used in previous RIBS studies. The occurrence of ANY of these events will qualify for the combined event. That is, Cardiac death OR Myocardial Infarctio OR target vessel revascularization. (for the cobined end point the first event will be censored for each patient and other subsequent events will not apply). For time related statistics, the first event will be censored in the KM curves. In addition to that, the time and occurrence of each individual event will be also analyzed. The same strategy will be followed for the other combined clinical outcome measures that, again, are classically defined in this field. | 1 year of clinical follow-yp | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) | This is a well-accepted outcome measure of individual clinical end-points | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Combined clinical outcome measure (cardiac death, myocardial infarction, target lesion revascularization) | This is a well-accepted outcome measure of individual clinical end-points. Definition of myocardial infarction is similar to that used in previous RIBS studies. The occurrence of ANY of these events will qualify for the combined event. That is, Cardiac death OR Myocardial Infarctio OR target vessel revascularization. (for the cobined end point the first event will be censored for each patient and other subsequent events will not apply). For time related statistics, the first event will be censored in the KM curves. In addition to that, the time and occurrence of each individual event will be also analyzed. The same strategy will be followed for the other combined clinical outcome measures that, again, are classically defined in this field. | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Cardiac death | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Total mortality | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Myocardial infarction | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Target vessel revascularization | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Target lesion revascularization | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Stent thrombosis | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | 
| Major bleeding | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-stent restenosis, Bioresorbable vascular scaffold, Coronary angiography