NCT02298413

Brief Summary

The investigators aim at evaluating the long-term (5-year) clinical outcome following Absorb BVS implantation in a real world, all-comers population of consecutive patients, as treated according to the indications, techniques and protocols used in the participating institutions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

November 15, 2014

Last Update Submit

February 3, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Scaffold thrombosis

    acute, subacute, late and very late

    1 year

  • Target lesion revascularization

    ischemia or angiographic-driven

    1 year

Secondary Outcomes (1)

  • MACE

    5 year

Interventions

PCI with Absorb scaffoldDEVICE

Implantation of biovascular scaffold during PCI

Also known as: biovascular resorbable scaffold

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is an all-comers study, and includes all consecutive patients who have been treated with 1 or more BVS in the study time lapse in each participating centre

You may qualify if:

  • Successful implantation of 1 or more coronary BVS
  • Age \<75 years
  • Patient's informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSD Emodinamica Dip Cardiovasc ASO S.Croce

Cuneo, Italy

Location

Related Publications (2)

  • Cortese B, Ielasi A, Moscarella E, Loi B, Tarantini G, Pisano F, Durante A, Pasquetto G, Colombo A, Tumminello G, Moretti L, Calabro P, Mazzarotto P, Varricchio A, Tespili M, Latini RA, Defilippi G, Corrado D, Steffenino G; RAI Investigators. Thirty-Day Outcomes After Unrestricted Implantation of Bioresorbable Vascular Scaffold (from the Prospective RAI Registry). Am J Cardiol. 2017 Jun 15;119(12):1924-1930. doi: 10.1016/j.amjcard.2017.03.017. Epub 2017 Mar 29.

    PMID: 28438304DERIVED

  • Cortese B, Ielasi A, Varricchio A, Tarantini G, LaVecchia L, Pisano F, Facchin M, Gistri R, D'Urbano M, Lucci V, Loi B, Tumminello G, Colombo A, Limbruno U, Nicolino A, Calzolari D, Tognoni G, Defilippi G, Buccheri D, Tespili M, Corrado D, Steffenino G; BVS-RAI investigators. Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb BVS: study design. Cardiovasc Revasc Med. 2015 Sep;16(6):340-3. doi: 10.1016/j.carrev.2015.05.010. Epub 2015 Jun 3.

    PMID: 26100975DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Alfonso Ielasi, MD

    AO Seriate

    PRINCIPAL INVESTIGATOR

  • Bernardo Cortese, MD

    AO Fatebenefratelli

    PRINCIPAL INVESTIGATOR

  • Donatella Corrado, PhD

    Istituto Di Ricerche Farmacologiche Mario Negri

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 15, 2014

First Posted

November 24, 2014

Study Start

May 1, 2013

Primary Completion

November 1, 2016

Study Completion

May 1, 2021

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

IT(1)