Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII)

Spanish Society of Cardiology

Status: Unknown

Conditions: Coronary In-stnent Restenosis

Treatments: Device: Treatment of restenosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03167424

RIBS VII

Details and patient eligibility

About

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.

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, 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 1 patient group

BVS restenosis

Description:

Patients with a Bioresorbable Vascular Scaffold Restenosis

Treatment:

Device: Treatment of restenosis