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

Primary Purpose

Coronary In-stent Restenosis

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Bioresorbable vascular scaffold. Absorb GT1 (Abbott)
Sponsored by
Spanish Society of Cardiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary In-stent Restenosis focused on measuring In-stent restenosis, Bioresorbable vascular scaffold, Stent, Drug-eluting stent, Coronary angiography, Scoring balloon

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Complexo Universitario Hospitalario de SantiagoRecruiting
  • Hospital Central de AsturiasRecruiting
  • Hospital Universitari de BellvitgeRecruiting
  • Hospital Universitario Puerta de HierroRecruiting
  • Hospital Universitario de CanariasRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital Universitario de La PrincesaRecruiting
  • Hospital Universitario 12 de OctubreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BVS implantation in patients with ISR

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Acute gain
Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter
Minimal lumen diameter
Acute angiographic parameter
Percent diameter stenosis
Acute angiographic parameter
Restenosis rate
Late angiographic parameter
Percent diameter stenosis
Late angiographic parameter
Late loss
Change in minimal lumen diameter from the final procedure to the follow-up angiogram at 6-9 months. Late angiographic parameter.
Net gain
Is the difference between acute gain and late loss. Late angiographic parameter
Loss index
Late angiographic parameter
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.
Cardiac death
Individual clinical outcome
Total mortality
Individual clinical outcome
Myocardial infarction
Individual clinical outcome
Target vessel revascularization
Individual clinical outcome
Target lesion revascularization
Individual clinical outcome
Stent thrombosis
Individual clinical outcome
Major bleeding
Individual clinical outcome
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

Full Information

First Posted
February 27, 2017
Last Updated
March 2, 2017
Sponsor
Spanish Society of Cardiology
Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Hospital Universitario de la Princesa, Abbott Medical Devices, Terumo Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03069066
Brief Title
Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)
Official Title
Prospective Study of Bioresorbable Vascular Scaffold Treatment With Scoring Balloon Pre-dilatation in Patients With In-stent Restenosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spanish Society of Cardiology
Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Hospital Universitario de la Princesa, Abbott Medical Devices, Terumo Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary In-stent Restenosis
Keywords
In-stent restenosis, Bioresorbable vascular scaffold, Stent, Drug-eluting stent, Coronary angiography, Scoring balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BVS implantation in patients with ISR
Arm Type
Experimental
Arm Description
BVS implantation in patients with ISR after scoring balloon pre-dilatation
Intervention Type
Device
Intervention Name(s)
Bioresorbable vascular scaffold. Absorb GT1 (Abbott)
Primary Outcome Measure Information:
Title
Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up
Description
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.
Time Frame
angiographic follow-up at 6-9 months
Title
Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization)
Description
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.
Time Frame
1 year of clinical follow-up
Secondary Outcome Measure Information:
Title
Acute gain
Description
Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter
Time Frame
procedure
Title
Minimal lumen diameter
Description
Acute angiographic parameter
Time Frame
procedure
Title
Percent diameter stenosis
Description
Acute angiographic parameter
Time Frame
procedure
Title
Restenosis rate
Description
Late angiographic parameter
Time Frame
6-9 months
Title
Percent diameter stenosis
Description
Late angiographic parameter
Time Frame
6-9 months
Title
Late loss
Description
Change in minimal lumen diameter from the final procedure to the follow-up angiogram at 6-9 months. Late angiographic parameter.
Time Frame
6-9 months
Title
Net gain
Description
Is the difference between acute gain and late loss. Late angiographic parameter
Time Frame
6-9 months
Title
Loss index
Description
Late angiographic parameter
Time Frame
6-9 months
Title
Combined clinical outcome measure (cardiac death, myocardial infarction, target lesion revascularization)
Description
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.
Time Frame
1 year, 2 years, 3 years, 4 years, 5 years
Title
Cardiac death
Description
Individual clinical outcome
Time Frame
1 year, 2 years, 3 years, 4 years, 5 years
Title
Total mortality
Description
Individual clinical outcome
Time Frame
1 year, 2 years, 3 years, 4 years, 5 years
Title
Myocardial infarction
Description
Individual clinical outcome
Time Frame
1 year, 2 years, 3 years, 4 years, 5 years
Title
Target vessel revascularization
Description
Individual clinical outcome
Time Frame
1 year, 2 years, 3 years, 4 years, 5 years
Title
Target lesion revascularization
Description
Individual clinical outcome
Time Frame
1 year, 2 years, 3 years, 4 years, 5 years
Title
Stent thrombosis
Description
Individual clinical outcome
Time Frame
1 year, 2 years, 3 years, 4 years, 5 years
Title
Major bleeding
Description
Individual clinical outcome
Time Frame
1 year, 2 years, 3 years, 4 years, 5 years
Title
Target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization)
Description
This is a well-accepted outcome measure of individual clinical end-points
Time Frame
1 year, 2 years, 3 years, 4 years, 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Complexo Universitario Hospitalario de Santiago
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramiro Trillo, MD
Email
ramirotrillo@mac.com
Facility Name
Hospital Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel del Valle, MD
Email
raqueldelvalle@gmail.com
Facility Name
Hospital Universitari de Bellvitge
City
L´Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Romaguera, MD
Email
rafaromaguera@gmail.com
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arturo Garcia-Touchard, MD
Email
agtouchard@gmail.com
Facility Name
Hospital Universitario de Canarias
City
San Cristobal de La Laguna
State/Province
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Ignacio Ga Bosa, MD
Email
franbosa@ull.edu.es
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicens Marti, MD
Email
vmarti@santpau.cat
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Masotti, MD
Email
masotti@clinic.ub.es
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Melgares, MD
Email
rafael.melgares.sspa@juntadeandalucia.es
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Alfonso Manterola, MD, PhD
Email
falf@hotmail.com
First Name & Middle Initial & Last Name & Degree
Javier Cuesta Cuesta, MD
Email
javicuestacuesta@hotmail.com
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maite Velazquez, MD
Email
maitevel05@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
12957423
Citation
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.
Results Reference
background
PubMed Identifier
15474698
Citation
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.
Results Reference
background
PubMed Identifier
16139121
Citation
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.
Results Reference
background
PubMed Identifier
16261546
Citation
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.
Results Reference
background
PubMed Identifier
16504631
Citation
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.
Results Reference
background
PubMed Identifier
16750678
Citation
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.
Results Reference
background
PubMed Identifier
18814274
Citation
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.
Results Reference
background
PubMed Identifier
18992651
Citation
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.
Results Reference
background
PubMed Identifier
22814777
Citation
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.
Results Reference
background
PubMed Identifier
24412457
Citation
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.
Results Reference
background
PubMed Identifier
25244700
Citation
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.
Results Reference
background
PubMed Identifier
26139054
Citation
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.
Results Reference
background
PubMed Identifier
32558692
Citation
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.
Results Reference
derived

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

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