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

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

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.

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)