Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)
- Conditions
- Coronary In-stent Restenosis
- Interventions
- Device: Bioresorbable vascular scaffold. Absorb GT1 (Abbott)
- Registration Number
- NCT03069066
- Lead Sponsor
- Spanish Society of Cardiology
- Brief Summary
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.
- 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, 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BVS implantation in patients with ISR Bioresorbable vascular scaffold. Absorb GT1 (Abbott) BVS implantation in patients with ISR after scoring balloon pre-dilatation
- Primary Outcome Measures
Name Time Method Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up angiographic follow-up at 6-9 months This is a single arm study and results will be analyzed this arm. However, the angiographic and clinical results will be also compared with those obtained in other arms of previous RIBS trials. In particular results will be compared with those found in the RIBS VI study.
Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization) 1 year of clinical follow-up 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 Acute gain procedure Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter
Percent diameter stenosis 6-9 months Late angiographic parameter
Cardiac death 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Restenosis rate 6-9 months Late angiographic parameter
Loss index 6-9 months Late angiographic parameter
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.Myocardial infarction 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Stent thrombosis 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Minimal lumen diameter procedure Acute angiographic parameter
Late loss 6-9 months Change in minimal lumen diameter from the final procedure to the follow-up angiogram at 6-9 months. Late angiographic parameter.
Target vessel revascularization 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Net gain 6-9 months Is the difference between acute gain and late loss. Late angiographic parameter
Major bleeding 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
Total mortality 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 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 Universitari de Bellvitge
🇪🇸L´Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain