Coronary In-stnent Restenosis Clinical Trial
— RIBS VIIOfficial title:
Observational Study of Treatment of Bioresorbable Vascular Scaffolds Restenosis
| Verified date | August 2017 |
| Source | Spanish Society of Cardiology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 90 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | 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 Universitario de La Princesa | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid |
| Spain | Hospital Central de Asturias | Oviedo | Asturias |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Spanish Society of Cardiology | Abbott Vascular, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Hospital Universitario de La Princesa (IIS-IP) |
Spain,
Alfonso F, Augé JM, Zueco J, Bethencourt A, López-Mínguez JR, Hernández JM, Bullones JA, Calvo I, Esplugas E, Pérez-Vizcayno MJ, Moreno R, Fernández C, Hernández R, Gama-Ribeiro V; RIBS Investigators. Long-term results (three to five years) of the Resteno — View Citation
Alfonso F, Cequier A, Angel J, Martí V, Zueco J, Bethencourt A, Mantilla R, López-Minguez JR, Gómez-Recio M, Morís C, Perez-Vizcayno MJ, Fernández C, Macaya C, Seabra-Gomes R; Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) Inve — View Citation
Alfonso F, Melgares R, Mainar V, Lezaún R, Vázquez N, Tascón J, Pomar F, Cequier A, Angel J, Pérez-Vizcayno MJ, Sabaté M, Bañuelos C, Fernández C, García JM; Restensois Intra-stent: Ballon angioplasty versus elective Stenting (RIBS) Investigators. Therape — View Citation
Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García del Blanco B, García-Touchard A, López-Minguéz JR, Benedicto A, Masotti M, Zueco J, Iñiguez A, Velázquez M, Moreno R, Mainar V, Domínguez A, Pomar F, Melgares R, Rivero F, Jiménez-Quevedo P, Gonzalo N, Fern — View Citation
Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García Del Blanco B, García-Touchard A, López-Minguéz JR, Rivero F, Masotti M, Zueco J, Cequier A, Morís C, Fernández-Ortíz A, Escaned J, Jiménez-Quevedo P, Gonzalo N, Fernández C, Macaya C; Restenosis Intra-stent — View Citation
Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García Del Blanco B, Seidelberger B, Iñiguez A, Gómez-Recio M, Masotti M, Velázquez MT, Sanchís J, García-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, López-Mínguez JR, Moreu J — View Citation
Alfonso F, Pérez-Vizcayno MJ, Dutary J, Zueco J, Cequier A, García-Touchard A, Martí V, Lozano I, Angel J, Hernández JM, López-Mínguez JR, Melgares R, Moreno R, Seidelberger B, Fernández C, Hernandez R; RIBS-III Study Investigators (under the auspices of — View Citation
Alfonso F, Pérez-Vizcayno MJ, Gómez-Recio M, Insa L, Calvo I, Hernández JM, Bullones JA, Hernández R, Escaned J, Macaya C, Gama-Ribeiro V, Leitao-Marques A; Restenosis Intrastent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. Implicat — View Citation
Alfonso F, Pérez-Vizcayno MJ, Hernández R, Bethencourt A, Martí V, López-Mínguez JR, Angel J, Iñiguez A, Morís C, Cequier A, Sabaté M, Escaned J, Jiménez-Quevedo P, Bañuelos C, Suárez A, Macaya C; RIBS-II Investigators. Long-term clinical benefit of sirol — View Citation
Alfonso F, Pérez-Vizcayno MJ, Hernandez R, Bethencourt A, Martí V, López-Mínguez JR, Angel J, Mantilla R, Morís C, Cequier A, Sabaté M, Escaned J, Moreno R, Bañuelos C, Suárez A, Macaya C; RIBS-II Investigators. A randomized comparison of sirolimus-elutin — View Citation
Alfonso F, Pérez-Vizcayno MJ, Hernandez R, Fernandez C, Escaned J, Bañuelos C, Bethencourt A, López-Mínguez JR, Angel J, Cequier A, Sabaté M, Morís C, Zueco J, Seabra-Gomes R; Restenosis Intra-Stent: Balloon Angioplasty Versus Elective Stent Implantation — View Citation
Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, López-Minguez JR, Angel J, Augé JM, Gómez-Recio M, Morís C, Seabra-Gomes R, Perez-Vizcayno MJ, Macaya C; Restenosis Intra-stent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. A — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
1 year of clinical follow-yp | |
| Secondary | 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 | 1 year, 2 years, 3 years, 4 years, 5 years | |
| Secondary | 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. | 1 year, 2 years, 3 years, 4 years, 5 years | |
| Secondary | Cardiac death | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | |
| Secondary | Total mortality | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | |
| Secondary | Myocardial infarction | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | |
| Secondary | Target vessel revascularization | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | |
| Secondary | Target lesion revascularization | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | |
| Secondary | Stent thrombosis | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years | |
| Secondary | Major bleeding | Individual clinical outcome | 1 year, 2 years, 3 years, 4 years, 5 years |