Costs, Effectiveness, QALYs, and Efficiency of Bioabsorbable Devices in Daily Clinical Practice

Coronary Stenosis Treated With Implant of Bioresorbable Devices Clinical Trial

— REPARA-QALY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02854007
• Other study ID #: COR-BVS-2016-01
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2016
• Last updated: July 29, 2016
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Sección Hemodinamica y Cardiologia Intervencionista
• Contact: Felipe Hernandez, MD
• Phone: +34-630068923
• Email: felipeivus[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Spanish Society of Cardiology
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Stenosis
• Coronary Stenosis Treated With Implant of Bioresorbable Devices

Intervention

Device:
• Coronary angioplasty with implant of bioresorbable device
Percutaneous coronary intervention

Locations

Country	Name	City	State
Spain	Hospital 12 de Octubre	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Sección Hemodinamica y Cardiologia Intervencionista

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality Adjusted Live Years (QALYs) gained since the first revascularization (the week before revascularization) to the end of follow-up (one year)	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	No
Secondary	"Target lesion failure", defined as cardiac death, target-vessel myocardial infarction, and target lesion ischemia at any time during the follow-up period.		1 year follow-up	Yes