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

Spanish Society of Cardiology100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Coronary In-stent Restenosis

Interventions

Bioresorbable vascular scaffold. Absorb GT1 (Abbott)DEVICE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (10)

Complexo Universitario Hospitalario de Santiago

Santiago de Compostela, A Coruña, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 year of clinical follow-up

Secondary Outcomes

Acute gain

Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter

Time frame: procedure

Minimal lumen diameter

Acute angiographic parameter

Time frame: procedure

Percent diameter stenosis

Acute angiographic parameter

Time frame: procedure

Restenosis rate

Data from ClinicalTrials.gov

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