Coronary In-stent Restenosis Clinical Trial
Official title:
Prospective Study of Bioresorbable Vascular Scaffold Treatment With Scoring Balloon Pre-dilatation in Patients With In-stent Restenosis
Verified date | March 2017 |
Source | Spanish Society of Cardiology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 85 Years |
Eligibility |
In-stent restenosis with ischemia. Signed Informed Consent IRB approval INCLUSION CRITERIA: PATIENT - Age > 20 and < 85 years of age - Acceptance of late angiographic evaluation - 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 - Allergy to antiplatelet agents - Women in childbearing age - Severe associated systemic diseases (including renal or liver failure) or diseases affecting life expectancy - Recent myocardial infarction - Time from index stent implantation < 1 month - Anticipated difficulties for late angiographic evaluation LESION - Stent thrombosis or large thrombus within the stent - Angiographic failure during initial stent implantation or persistence or large dissection. - Severe tortuosity or calcification or major difficulties during previous stent implantation - Vessel diameter < 2.25 mm (visual assessment) - Stenosis outside stent stent edge (edge ISR are eligible) - Very diffuse ISR (>30 mm in length) |
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), St. Jude Medical, Terumo Medical Corporation |
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 Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study. J Am Coll Cardiol. 2005 Sep 6;46(5):756-60. — 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) Investigators.. Value of the American College of Cardiology/American Heart Association angiographic classification of coronary lesion morphology in patients with in-stent restenosis. Insights from the Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) randomized trial. Am Heart J. 2006 Mar;151(3):681.e1-681.e9. — 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.. Therapeutic implications of in-stent restenosis located at the stent edge. Insights from the restenosis intra-stent balloon angioplasty versus elective stenting (RIBS) randomized trial. Eur Heart J. 2004 Oct;25(20):1829-35. — 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, Fernández C, Macaya C; RIBS IV Study Investigators (under auspices of Interventional Cardiology Working Group of Spanish Society of Cardiology).. A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial. J Am Coll Cardiol. 2015 Jul 7;66(1):23-33. doi: 10.1016/j.jacc.2015.04.063. — 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: drug-eluting Balloon vs. everolimus-eluting Stent (RIBS IV) Study Investigators (under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology).. Rationale and design of the RIBS IV randomised clinical trial (drug-eluting balloons versus everolimus-eluting stents for patients with drug-eluting stent restenosis). EuroIntervention. 2015 Jul;11(3):336-42. doi: 10.4244/EIJY14M09_07. — 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, Martí V, Moreno R, Jiménez-Quevedo P, Gonzalo N, Fernández C, Macaya C; RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology.. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol. 2014 Apr 15;63(14):1378-86. doi: 10.1016/j.jacc.2013.12.006. — 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 the Working Group on Interventional Cardiology of the Spanish Society of Cardiology).. Implantation of a drug-eluting stent with a different drug (switch strategy) in patients with drug-eluting stent restenosis. Results from a prospective multicenter study (RIBS III [Restenosis Intra-Stent: Balloon Angioplasty Versus Drug-Eluting Stent]). JACC Cardiovasc Interv. 2012 Jul;5(7):728-37. doi: 10.1016/j.jcin.2012.03.017. — 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.. Implications of the "watermelon seeding" phenomenon during coronary interventions for in-stent restenosis. Catheter Cardiovasc Interv. 2005 Dec;66(4):521-7. — 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 sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study. J Am Coll Cardiol. 2008 Nov 11;52(20):1621-7. doi: 10.1016/j.jacc.2008.08.025. — 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-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial. J Am Coll Cardiol. 2006 Jun 6;47(11):2152-60. — 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 (RIBS-I) and Restenosis Intra-Stent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) Investigators.. Sirolimus-eluting stents versus bare-metal stents in patients with in-stent restenosis: results of a pooled analysis of two randomized studies. Catheter Cardiovasc Interv. 2008 Oct 1;72(4):459-67. doi: 10.1002/ccd.21694. — 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 randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis. J Am Coll Cardiol. 2003 Sep 3;42(5):796-805. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up | 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. | angiographic follow-up at 6-9 months | |
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-up | |
Secondary | Acute gain | Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter | procedure | |
Secondary | Minimal lumen diameter | Acute angiographic parameter | procedure | |
Secondary | Percent diameter stenosis | Acute angiographic parameter | procedure | |
Secondary | Restenosis rate | Late angiographic parameter | 6-9 months | |
Secondary | Percent diameter stenosis | Late angiographic parameter | 6-9 months | |
Secondary | Late loss | Change in minimal lumen diameter from the final procedure to the follow-up angiogram at 6-9 months. Late angiographic parameter. | 6-9 months | |
Secondary | Net gain | Is the difference between acute gain and late loss. Late angiographic parameter | 6-9 months | |
Secondary | Loss index | Late angiographic parameter | 6-9 months | |
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 | |
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 |
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