Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03069066
• Other study ID #: RIBS VI scoring
• Status: Recruiting
• Phase: Phase 4
• First received: February 27, 2017
• Last updated: March 2, 2017
• Start date: January 2016
• Est. completion date: December 2021

Study information

• Verified date: March 2017
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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)

Related Conditions & MeSH terms

• Coronary In-stent Restenosis

Intervention

Device:
• Bioresorbable vascular scaffold. Absorb GT1 (Abbott)

Locations

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

Sponsors (6)

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

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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

Outcome

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