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

Spanish Society of Cardiology

Status and phase

Unknown

Phase 4

Conditions

Coronary In-stent Restenosis

Treatments

Device: Bioresorbable vascular scaffold. Absorb GT1 (Abbott)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03069066

RIBS VI scoring

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)