Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)

Study Overview
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Brief Summary
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Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the treatment of patients suffering from ISR after scoring balloon pre-dilatation.

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, data on the value of BVS in patients with ISR is scarce. BVS are very effective to inhibit neointimal proliferation and they avoid the need of implanting a new permanent metal layer. Accordingly, currently, there is a major interest to elucidate the potential value of BVS in patients with ISR. The use of scoring balloon pre-dilatation has not been studied previously in this setting. This prospective Spanish multicenter study will assess the clinical and angiographic outcome of patients with ISR treated with BVS with scoring balloon pre-dilatation. BVS will be implanted in selected patients (fulfilling inclusion and exclusion criteria) presenting with either BMS-ISR or DES-ISR. Care will be paid to ensure device optimization. Scoring balloon pre-dilatation is mandatory. Angiographic follow-up will be obtained at 6-9 months. A centralized angiographic corelab will be used to provide QCA measurements. Clinical follow-up will be also obtained at 1 year and then yearly. Clinical events will be adjudicated by an independent Clinical Event Committee.

Official Title
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Prospective Study of Bioresorbable Vascular Scaffold Treatment With Scoring Balloon Pre-dilatation in Patients With In-stent Restenosis

Conditions
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Coronary In-stent Restenosis

Intervention / Treatment
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* Device: Bioresorbable vascular scaffold. Absorb GT1 (Abbott)


Participation Criteria
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Eligibility Criteria
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In-stent restenosis with ischemia. Signed Informed Consent IRB approval INCLUSION CRITERIA: PATIENT Age > 20 and < 85 years of age Acceptance of late angiographic evaluation 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 Allergy to antiplatelet agents Women in childbearing age Severe associated systemic diseases (including renal or liver failure) or diseases affecting life expectancy Recent myocardial infarction Time from index stent implantation < 1 month Anticipated difficulties for late angiographic evaluation LESION Stent thrombosis or large thrombus within the stent Angiographic failure during initial stent implantation or persistence or large dissection. Severe tortuosity or calcification or major difficulties during previous stent implantation Vessel diameter < 2.25 mm (visual assessment) Stenosis outside stent stent edge (edge ISR are eligible) Very diffuse ISR (>30 mm in length)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BVS implantation in patients with ISR<br>BVS implantation in patients with ISR after scoring balloon pre-dilatation | Device: Bioresorbable vascular scaffold. Absorb GT1 (Abbott)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up | This is a single arm study and results will be analyzed this arm. However, the angiographic and clinical results will be also compared with those obtained in other arms of previous RIBS trials. In particular results will be compared with those found in the RIBS VI study. | angiographic follow-up at 6-9 months | 
| 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-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute gain | Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter | procedure | 
| Minimal lumen diameter | Acute angiographic parameter | procedure | 
| Percent diameter stenosis | Acute angiographic parameter | procedure | 
| Restenosis rate | Late angiographic parameter | 6-9 months | 
| Percent diameter stenosis | Late angiographic parameter | 6-9 months | 
| Late loss | Change in minimal lumen diameter from the final procedure to the follow-up angiogram at 6-9 months. Late angiographic parameter. | 6-9 months | 
| Net gain | Is the difference between acute gain and late loss. Late angiographic parameter | 6-9 months | 
| Loss index | Late angiographic parameter | 6-9 months | 
| 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 | 
| 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 | 

 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, Stent, Drug-eluting stent, Coronary angiography, Scoring balloon