Costs, Effectiveness, QALYs, and Efficiency of Bioabsorbable Devices in Daily Clinical Practice (REPARA-QALY)

July 29, 2016 updated by: Sección Hemodinamica y Cardiologia Intervencionista

REgistry of PAtients Treated With bioabsoRbable Devices in dAily Clinical Practice: Costs, Effectiveness, QALYs, and Efficiency. REPARA-QALY Registry

A multicenter, prospective, observational cohort study with clinical, quality of life, and economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients with ischemic heart disease revascularized with Absorb in standard clinical practice in Spain. A before-after comparative analysis will be performed, so that each patient will act as his/her own control.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Economical evaluation study of the efficiency of Absorb in a cohort of patients with ischemic heart disease who have undergone revascularization with Absorb based on the criteria established according to standard clinical practice. A comparison group without Absorb cannot be used for ethical reasons. Thus, each patient will act as his/her own control, and a before-after comparison will be done. This is therefore a prospective, observational cohort study with concurrent data collection.

Primary objective:

  • To assess utility (QALYs gained) in patients implanted Absorb in standard clinical practice conditions.

Secondary objectives:

  • To assess effectiveness (clinical outcomes) in patients who undergo coronary revascularization with Absorb implantation.
  • To assess costs (direct and indirect) derived from coronary revascularization with Absorb implantation.
  • To assess efficiency in terms of cost/utility (cost per QALY gained) and cost/effectiveness (cost per MACE -major cardiac adverse events- free patient).

Study Type

Observational

Enrollment (Anticipated)

1000

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

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 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ischemic heart disease who have undergone percutaneous coronary revascularization with Absorb according to standard clinical practice. One thousand revascularized patients will be recruited at 40 sites.

Description

Inclusion Criteria:

  • Age ranging from 18 and 95 years.
  • Both sexes.
  • Coronary revascularization with Absorb for any of the following lesions: de novo, restenosis, segment ST elevation myocardial infarction (STEMI), chronic total occlusion (CTO), trunk, venous graft, or bifurcations.
  • Informed consent signed before participation in the study is started.

Exclusion Criteria:

  • Pregnant or nursing woman..
  • Cardiogenic shock.
  • Refusal to participate in the study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary stenosis treated with Absorb
Patients with ischemic heart disease who have undergone percutaneous coronary revascularization with Absorb according to standard clinical practice. One thousand revascularized patients will be recruited at 40 siteS.
Device: Coronary angioplasty with implant of bioresorbable device
Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality Adjusted Live Years (QALYs) gained since the first revascularization (the week before revascularization) to the end of follow-up (one year)
Time Frame: 1 year follow-up
To construct QALYs, the EuroQoL-5D-3L (EQ-5D) will be used for the quality of life dimension, while the time elapsed between each EQ-5D measurement will be considered for the time dimension. If a patient dies, the value of EQ-5D is 0 from the date of death.
1 year follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
"Target lesion failure", defined as cardiac death, target-vessel myocardial infarction, and target lesion ischemia at any time during the follow-up period.
Time Frame: 1 year follow-up
1 year follow-up

Collaborators and Investigators

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

Sponsor

Sección Hemodinamica y Cardiologia Intervencionista

Investigators

  • Principal Investigator: Felipe Hernandez, MD, Hospital 12 de Octubre, Madrid

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

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR-BVS-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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