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

NCT ID: NCT03069066

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-12-31

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.

Conditions

Coronary In-stent Restenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BVS implantation in patients with ISR

BVS implantation in patients with ISR after scoring balloon pre-dilatation

Group Type: EXPERIMENTAL

Bioresorbable vascular scaffold. Absorb GT1 (Abbott)

Intervention Type: DEVICE

Interventions

Bioresorbable vascular scaffold. Absorb GT1 (Abbott)

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role: collaborator

Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

OTHER

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Terumo Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Spanish Society of Cardiology

OTHER

Sponsor Role: lead

Responsible Party

Fernando Alfonso

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Complexo Universitario Hospitalario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status: RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Site Status: RECRUITING

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status: RECRUITING

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status: RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Ramiro Trillo, MD

Role: primary

ramirotrillo@mac.com

Vicens Marti, MD

Role: primary

vmarti@santpau.cat

Monica Masotti, MD

Role: primary

masotti@clinic.ub.es

Rafael Romaguera, MD

Role: primary

rafaromaguera@gmail.com

Rafael Melgares, MD

Role: primary

rafael.melgares.sspa@juntadeandalucia.es

Fernando Alfonso Manterola, MD, PhD

Role: primary

falf@hotmail.com

Javier Cuesta Cuesta, MD

Role: backup

javicuestacuesta@hotmail.com

Maite Velazquez, MD

Role: primary

maitevel05@gmail.com

Arturo Garcia-Touchard, MD

Role: primary

agtouchard@gmail.com

Raquel del Valle, MD

Role: primary

raqueldelvalle@gmail.com

Francisco Ignacio Ga Bosa, MD

Role: primary

franbosa@ull.edu.es

References

Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, Lopez-Minguez JR, Angel J, Auge JM, Gomez-Recio M, Moris 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. doi: 10.1016/s0735-1097(03)00852-0.

Reference Type: BACKGROUND

PMID: 12957423 (View on PubMed)

Alfonso F, Melgares R, Mainar V, Lezaun R, Vazquez N, Tascon J, Pomar F, Cequier A, Angel J, Perez-Vizcayno MJ, Sabate M, Banuelos C, Fernandez C, Garcia 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. doi: 10.1016/j.ehj.2004.07.019.

Reference Type: BACKGROUND

PMID: 15474698 (View on PubMed)

Alfonso F, Auge JM, Zueco J, Bethencourt A, Lopez-Minguez JR, Hernandez JM, Bullones JA, Calvo I, Esplugas E, Perez-Vizcayno MJ, Moreno R, Fernandez C, Hernandez 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. doi: 10.1016/j.jacc.2005.05.050.

Reference Type: BACKGROUND

PMID: 16139121 (View on PubMed)

Alfonso F, Perez-Vizcayno MJ, Gomez-Recio M, Insa L, Calvo I, Hernandez JM, Bullones JA, Hernandez 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. doi: 10.1002/ccd.20524.

Reference Type: BACKGROUND

PMID: 16261546 (View on PubMed)

Alfonso F, Cequier A, Angel J, Marti V, Zueco J, Bethencourt A, Mantilla R, Lopez-Minguez JR, Gomez-Recio M, Moris C, Perez-Vizcayno MJ, Fernandez 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. doi: 10.1016/j.ahj.2005.10.014.

Reference Type: BACKGROUND

PMID: 16504631 (View on PubMed)

Alfonso F, Perez-Vizcayno MJ, Hernandez R, Bethencourt A, Marti V, Lopez-Minguez JR, Angel J, Mantilla R, Moris C, Cequier A, Sabate M, Escaned J, Moreno R, Banuelos C, Suarez 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. doi: 10.1016/j.jacc.2005.10.078.

Reference Type: BACKGROUND

PMID: 16750678 (View on PubMed)

Alfonso F, Perez-Vizcayno MJ, Hernandez R, Fernandez C, Escaned J, Banuelos C, Bethencourt A, Lopez-Minguez JR, Angel J, Cequier A, Sabate M, Moris 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.

Reference Type: BACKGROUND

PMID: 18814274 (View on PubMed)

Alfonso F, Perez-Vizcayno MJ, Hernandez R, Bethencourt A, Marti V, Lopez-Minguez JR, Angel J, Iniguez A, Moris C, Cequier A, Sabate M, Escaned J, Jimenez-Quevedo P, Banuelos C, Suarez 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.

Reference Type: BACKGROUND

PMID: 18992651 (View on PubMed)

Alfonso F, Perez-Vizcayno MJ, Dutary J, Zueco J, Cequier A, Garcia-Touchard A, Marti V, Lozano I, Angel J, Hernandez JM, Lopez-Minguez JR, Melgares R, Moreno R, Seidelberger B, Fernandez 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.

Reference Type: BACKGROUND

PMID: 22814777 (View on PubMed)

Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Seidelberger B, Iniguez A, Gomez-Recio M, Masotti M, Velazquez MT, Sanchis J, Garcia-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, Lopez-Minguez JR, Moreu J, Marti V, Moreno R, Jimenez-Quevedo P, Gonzalo N, Fernandez 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. Epub 2014 Jan 8.

Reference Type: BACKGROUND

PMID: 24412457 (View on PubMed)

Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Rivero F, Masotti M, Zueco J, Cequier A, Moris C, Fernandez-Ortiz A, Escaned J, Jimenez-Quevedo P, Gonzalo N, Fernandez 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.

Reference Type: BACKGROUND

PMID: 25244700 (View on PubMed)

Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Benedicto A, Masotti M, Zueco J, Iniguez A, Velazquez M, Moreno R, Mainar V, Dominguez A, Pomar F, Melgares R, Rivero F, Jimenez-Quevedo P, Gonzalo N, Fernandez 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.

Reference Type: BACKGROUND

PMID: 26139054 (View on PubMed)

Alfonso F, Cuesta J, Garcia Del Blanco B, Bosa F, Perez de Prado A, Masotti M, Trillo R, Rumoroso JR, Moreno R, Cequier A, Gutierrez H, Garcia Touchard A, Lopez-Minguez JR, Zueco J, Serra A, Velazquez M, Moris C, Bastante T, Garcia-Guimaraes M, Rivero F, Fernandez-Perez C; Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment with Scoring Balloon Pre-dilatation (RIBS VI 'Scoring') Study Investigators (under the auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology). Scoring balloon predilation before bioresorbable vascular scaffold implantation in patients with in-stent restenosis: the RIBS VI 'scoring' study. Coron Artery Dis. 2021 Mar 1;32(2):96-104. doi: 10.1097/MCA.0000000000000904.

Reference Type: DERIVED

PMID: 32558692 (View on PubMed)

Other Identifiers

RIBS VI scoring

Identifier Type: -

Identifier Source: org_study_id