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Coronary In-stnent RestenosisRIBS VIINCT03167424

Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis

An observational study of Coronary In-stnent Restenosis, run by Spanish Society of Cardiology at 10 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular Scaffolds (Abbott Vascular) remains a challenge. This study will assess the incidence, predisposing factors, pathophysiology and prognosis of the patient in this setting. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Coronary In-stnent Restenosis
What is being tested?
Treatment of restenosis
Type of treatment
Medical device
How many people
100 participants
Where
10 sitesSpain
Study dates
May 2016to Dec 2021
How long will I take part?
5 Years
Phase
Observational
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: In-stent restenosis of bioresorbable vascular scaffold.

Who may be able to join

  • PATIENT
  • Age > 20 and < 85 years of age
  • Angina or objective evidence of ischemia LESION
  • ISR (>50% diameter stenosis on visual assessment)
  • Previous stent location known
  • Refuse to sign Informed Consent

Who cannot join

  • PATIENT

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Spain10 sites, 10 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    Vicens Marti, MD, vmarti@santpau.cat

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

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

    Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

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

    Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Rafael Romaguera, MD, rafaromaguera@gmail.com

    Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006

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

    Javier Cuesta Cuesta, MD, javicuestacuesta@hotmail.com

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Maite Velazquez, MD, maitevel05@gmail.com

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

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

    Recruiting

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias, 33006

    Raquel del Valle, MD, raqueldelvalle@gmail.com

    Recruiting

  • Hospital Universitario de Canarias

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

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

    Recruiting

  • Complexo Universitario Hospitalario de Santiago

    Santiago de Compostela, A Coruña, 15006

    Ramiro Trillo, MD, ramirotrillo@mac.com

    Recruiting

Other trials in Spain

About this study

Official title: Observational Study of Treatment of Bioresorbable Vascular Scaffolds Restenosis

The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular Scaffolds (Abbott Vascular) remains a challenge. This study will assess the incidence, predisposing factors, pathophysiology and prognosis of the patient in this setting.

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, existing data about ISR of BVS are scarce (isolated cases and retrospective series with very few patients) on the incidence, predisposing factors, pathophysiology, treatment, and long-term prognosis of these patients. In this sense, a prospective Spanish registry of patients with ISR of DVB can obtain a very relevant clinical information that allows us to advance in our knowledge about this phenomenon that helps to prevent it and to treat it in the safest and most effective way possible.

Clinical events will be adjudicated by an independent Clinical Event Committee.

Being tested
Treatment of restenosis
Keywords
In-stent restenosis, Bioresorbable vascular scaffold, Coronary angiography

What participants receive

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

  • Treatment of restenosisDevice

    Treatment of in-stent restenosis

Study groups in NCT03167424
Study groupRoleWhat they receive
BVS restenosisPatients with a Bioresorbable Vascular Scaffold Restenosis
Receives: Device: Treatment of restenosis

What is being measured

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

  1. 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.

    Measured: 1 year of clinical follow-yp

Secondary outcomes (9)

  1. 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

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

  2. 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.

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

  3. Cardiac death

    Individual clinical outcome

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

  4. Total mortality

    Individual clinical outcome

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

  5. Myocardial infarction

    Individual clinical outcome

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

  6. Target vessel revascularization

    Individual clinical outcome

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

  7. Target lesion revascularization

    Individual clinical outcome

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

  8. Stent thrombosis

    Individual clinical outcome

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

  9. 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 posted30 May 2017
  2. Study startMay 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03167424
Sponsor's protocol ID
RIBS VII
Acronym
RIBS VII
Status last verified
Aug 2017
First submitted
24 May 2017
Last updated
11 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
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, Ojeda S, Camacho-Freire S, Garcia Del Blanco B, Vaquerizo B, Zueco J, Trillo R, Mauri J, Velazquez M, Cordoba-Soriano JG, Serra A, Navarro F, Pan M, Diaz J, Otaegui I, Salvatella N, De la TorreHernandez JM, Val DD, Bastante T, Rivero F; Under the auspices of the Association of Interventional Cardiology of the Spanish Society of Cardiology. Procedural Results and One-Year Clinical Outcomes of Treatment of Bioresorbable Vascular Scaffolds Restenosis (from the RIBS VII Prospective Study). Am J Cardiol. 2022 Jan 1;162:31-40. doi: 10.1016/j.amjcard.2021.09.027.

    PubMed 34903344

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary In-stnent Restenosis, run by Spanish Society of Cardiology at 10 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 6 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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.

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?

Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization) (time frame: 1 year of clinical follow-yp). 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 NCT03167424, which also lists 13 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 11 Aug 2017.

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