NCT03167424 - Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis | Crick

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Coronary In-stnent Restenosis

Interventions

Treatment of restenosisDEVICE

Treatment of in-stent restenosis

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (10)

Complexo Universitario Hospitalario de Santiago

Santiago de Compostela, A Coruña, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

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-yp

Secondary Outcomes

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

Time frame: 1 year, 2 years, 3 years, 4 years, 5 years

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.

Time frame: 1 year, 2 years, 3 years, 4 years, 5 years