Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis
- Conditions
- Coronary In-stnent Restenosis
- Interventions
- Device: Treatment of restenosis
- Registration Number
- NCT03167424
- Lead Sponsor
- Spanish Society of Cardiology
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BVS restenosis Treatment of restenosis Patients with a Bioresorbable Vascular Scaffold Restenosis
- Primary Outcome Measures
Name Time Method Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization) 1 year of clinical follow-yp 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.
- Secondary Outcome Measures
Name Time Method Stent thrombosis 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Major bleeding 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Combined clinical outcome measure (cardiac death, myocardial infarction, target lesion revascularization) 1 year, 2 years, 3 years, 4 years, 5 years 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.
Cardiac death 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) 1 year, 2 years, 3 years, 4 years, 5 years This is a well-accepted outcome measure of individual clinical end-points
Target vessel revascularization 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Total mortality 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Myocardial infarction 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Target lesion revascularization 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Trial Locations
- Locations (10)
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitari de Bellvitge
🇪🇸L´Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Universitario de Canarias
🇪🇸San Cristobal de La Laguna, Santa Cruz de Tenerife, Spain
Complexo Universitario Hospitalario de Santiago
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain