Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII)

August 9, 2017 updated by: Fernando Alfonso, Spanish Society of Cardiology

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15006
        • Recruiting
        • Complexo Universitario Hospitalario de Santiago
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Recruiting
        • Hospital Central de Asturias
    • Barcelona
      • L´Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
    • Santa Cruz de Tenerife
      • San Cristobal de La Laguna, Santa Cruz de Tenerife, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In-stent restenosis of bioresorbable vascular scaffold.

Description

In-stent restenosis of BVS with ischemia. Signed Informed Consent IRB approval.

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

PATIENT

  • Inclusion in other clinical research protocol
  • Refuse to sign Informed Consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BVS restenosis
Patients with a Bioresorbable Vascular Scaffold Restenosis
Device: Treatment of restenosis
Treatment of in-stent restenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization)
Time Frame: 1 year of clinical follow-yp

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-yp

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization)
Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years
This is a well-accepted outcome measure of individual clinical end-points
1 year, 2 years, 3 years, 4 years, 5 years
Combined clinical outcome measure (cardiac death, myocardial infarction, target lesion revascularization)
Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years
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
Cardiac death
Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years
Individual clinical outcome
1 year, 2 years, 3 years, 4 years, 5 years
Total mortality
Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years
Individual clinical outcome
1 year, 2 years, 3 years, 4 years, 5 years
Myocardial infarction
Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years
Individual clinical outcome
1 year, 2 years, 3 years, 4 years, 5 years
Target vessel revascularization
Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years
Individual clinical outcome
1 year, 2 years, 3 years, 4 years, 5 years
Target lesion revascularization
Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years
Individual clinical outcome
1 year, 2 years, 3 years, 4 years, 5 years
Stent thrombosis
Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years
Individual clinical outcome
1 year, 2 years, 3 years, 4 years, 5 years
Major bleeding
Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years
Individual clinical outcome
1 year, 2 years, 3 years, 4 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Society of Cardiology

Collaborators

Abbott Medical Devices
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RIBS VII

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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