Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment (RIBS VI)
- Conditions
- Coronary In-stent Restenosis
- Interventions
- Device: Bioresorbable vascular scaffold
- Registration Number
- NCT02672878
- 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.
- 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.
This prospective Spanish multicenter study will assess the clinical and angiographic outcome of patients with ISR treated with BVS. 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. 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
- 130
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 -
- 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 per arm. However, the angiographic and clinical results will be also compared with those obtained in other arms of previous RIBS trials
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.
- 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.
Minimal lumen diameter procedure Acute angiographic parameter
Restenosis rate 6-9 months Late 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.
Net gain 6-9 months Is the difference between acute gain and late loss. Late angiographic parameter.
Percent diameter stenosis 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.
Cardiac death 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Loss index 6-9 months Late angiographic parameter
Total mortality 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
Myocardial infarction 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Target vessel revascularization 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
Major bleeding 1 year, 2 years, 3 years, 4 years, 5 years Individual clinical outcome
Trial Locations
- Locations (19)
Hospital Universitari de Bellvitge
🇪🇸L´Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario Infanta Cristina
🇪🇸Badajoz, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitari Vall d´Hebron
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Complejo Asistencial de León
🇪🇸León, Spain
Complejo Hospitalario de Toledo
🇪🇸Toledo, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hospital de Galdakao
🇪🇸Vizcaya, 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