MedTrace Logo

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

NCT03069066 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

  • Coronary In-stent Restenosis

Interventions

DEVICE

Bioresorbable vascular scaffold. Absorb GT1 (Abbott)

Sponsors & Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    collaborator OTHER

  • Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

    collaborator OTHER

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Terumo Medical Corporation

    collaborator INDUSTRY

  • Spanish Society of Cardiology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-12-31
Completion
2021-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03069066 on ClinicalTrials.gov