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Coronary In-stent RestenosisPhase 4RIBS VINCT02672878

Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment (RIBS VI)

A Phase 4 study testing Bioresorbable vascular scaffold in people with Coronary In-stent Restenosis, run by Spanish Society of Cardiology at 19 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Coronary In-stent Restenosis
What is being tested?
Bioresorbable vascular scaffold
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
19 sitesSpain
Study dates
Apr 2014to Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 20Show fewer
  • Previous stent location known
  • 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)

Who cannot join

  • PATIENT

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Spain19 sites

  • Hospital Universitario Infanta Cristina

    Badajoz, Badajoz, 06080

    Jose Ramón López Minguez, MD, lopez-minguez@hotmail.com

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

    Vicens Marti, MD, vmarti@santpau.cat

  • Hospital Universitari Vall d´Hebron

    Barcelona, Barcelona, 08035

    Imanol Otaeghi, MD, iotaegui@hotmail.com

  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036

    Monica Masotti, MD, masotti@clinic.ub.es

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada, 18014

    Rafael Melgares, MD, rafael.melgares.sspa@juntadeandalucia.es

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Rafael Romaguera, MD, rafaromaguera@gmail.com

  • Complejo Asistencial de León

    León, León, 24071

    Armando Pérez, MD, aperez@secardiologia.es

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006

    Fernando Alfonso Manterola, MD, PhD, falf@hotmail.com

    Javier Cuesta Cuesta, MD, javicuestacuesta@hotmail.com

  • Hospital Ramón y Cajal

    Madrid, Madrid, 28034

    Rosana Hernández, MD, rhernandez_antolin@hotmail.com

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    Maite Velazquez, MD, maitevel05@gmail.com

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

    Raúl Moreno, MD, raulmorenog@hotmail.com

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

    Arturo Garcia-Touchard, MD, agtouchard@gmail.com

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias, 33006

    Raquel del Valle, MD, raqueldelvalle@gmail.com

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320

    Francisco Ignacio Ga Bosa, MD, franbosa@ull.edu.es

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

    Javier Zueco, MD, jzueco@humv.es

  • Complexo Universitario Hospitalario de Santiago

    Santiago de Compostela, A Coruña, 15006

    Ramiro Trillo, MD, ramirotrillo@mac.com

  • Complejo Hospitalario de Toledo

    Toledo, Toledo, 45004

    José Moreu, MD, jmoreu@sescam.jccm.es

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid, 47005

    Hipólito Gutierrez, MD, hggmaire@gmail.com

  • Hospital de Galdakao

    Vizcaya, Vizcaya, 48960

    Jose Ramón Rumoroso, MD, rumo@secardiologia.es

Other trials in Spain

About this study

Official title: Prospective Study of Bioresorbable Vascular Scaffold Treatment in Patients With In-stent Restenosis

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.

Read the 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.

This prospective Spanish multicenter study will assess the clinical and angiographic outcome of patients with ISR treated with BVS. 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. 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.

Being tested
Bioresorbable vascular scaffold
Keywords
In-stent restenosis, Bioresorbable vascular scaffold, Stent, Drug-eluting stent, Coronary angiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioresorbable vascular scaffoldDevice

Study groups in NCT02672878
Study groupRoleWhat they receive
BVS implantation in patients with ISRExperimentalNot described
Receives: Device: Bioresorbable vascular scaffold

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 per arm. However, the angiographic and clinical results will be also compared with those obtained in other arms of previous RIBS trials

    Measured: angiographic follow-up at 6-9 months

  2. 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.

    Measured: 1 year of clinical follow-up

Secondary outcomes (16)

  1. Acute gain

    Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter.

    Measured: procedure

  2. Minimal lumen diameter

    Acute angiographic parameter

    Measured: procedure

  3. Percent diameter stenosis

    Acute angiographic parameter

    Measured: procedure

  4. Restenosis rate

    Late angiographic parameter

    Measured: 6-9 months

  5. Percent diameter stenosis

    Late angiographic parameter

    Measured: 6-9 months

  6. Late loss

    Change in minimal lumen diameter from the final procedure to the follow-up angiogram at 6-9 months. Late angiographic parameter.

    Measured: 6-9 months

  7. Net gain

    Is the difference between acute gain and late loss. Late angiographic parameter.

    Measured: 6-9 months

  8. Loss index

    Late angiographic parameter

    Measured: 6-9 months

  9. 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.

    Measured: 1 year, 2 years, 3 years, 4 years, 5 years

  10. Cardiac death

    Individual clinical outcome

    Measured: 1 year, 2 years, 3 years, 4 years, 5 years

  11. Total mortality

    Individual clinical outcome

    Measured: 1 year, 2 years, 3 years, 4 years, 5 years

  12. Myocardial infarction

    Individual clinical outcome

    Measured: 1 year, 2 years, 3 years, 4 years, 5 years

  13. Target vessel revascularization

    Individual clinical outcome

    Measured: 1 year, 2 years, 3 years, 4 years, 5 years

  14. Target lesion revascularization

    Individual clinical outcome

    Measured: 1 year, 2 years, 3 years, 4 years, 5 years

  15. Stent thrombosis

    Individual clinical outcome

    Measured: 1 year, 2 years, 3 years, 4 years, 5 years

  16. Major bleeding

    Individual clinical outcome

    Measured: 1 year, 2 years, 3 years, 4 years, 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2016 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2016
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02672878
Sponsor's protocol ID
RIBS VI
Acronym
RIBS VI
Status last verified
Feb 2017
First submitted
5 Jan 2016
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12957423

  • 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.

    PubMed 15474698

  • 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.

    PubMed 16139121

  • 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.

    PubMed 16261546

  • 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.

    PubMed 16504631

  • 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.

    PubMed 16750678

  • 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.

    PubMed 18814274

  • 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.

    PubMed 18992651

  • 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.

    PubMed 22814777

  • 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.

    PubMed 24412457

  • 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.

    PubMed 25244700

  • 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.

    PubMed 26139054

  • 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.

    PubMed 32558692

  • Alfonso F, Cuesta J, Perez-Vizcayno MJ, Garcia Del Blanco B, Rumoroso JR, Bosa F, Perez de Prado A, Masotti M, Moreno R, Cequier A, Gutierrez H, Garcia Touchard A, Lopez-Minguez JR, Zueco J, Marti V, Velazquez M, Moris C, Bastante T, Garcia-Guimaraes M, Rivero F, Fernandez C; Interventional Cardiology Working Group of the Spanish Society of Cardiology. Bioresorbable Vascular Scaffolds for Patients With In-Stent Restenosis: The RIBS VI Study. JACC Cardiovasc Interv. 2017 Sep 25;10(18):1841-1851. doi: 10.1016/j.jcin.2017.06.064. Epub 2017 Aug 30.

    PubMed 28866036

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bioresorbable vascular scaffold in people with Coronary In-stent Restenosis, run by Spanish Society of Cardiology at 19 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up (time frame: angiographic follow-up at 6-9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02672878, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.

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