Clinical trial NCT02256449: REPARA Study: REgistry of PAtients With bioResorbable Device in Daily Clinical prActice
Official title: Registry of Patients With Bioresorbable Device in Daily Clinical Practice. REPARA Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Lesions With Implantation of Coronary Device
Keywords: Coronary artery disease; angioplasty; bioresorbable device
Lead sponsor: Sección Hemodinamica y Cardiologia Intervencionista
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 2440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with native coronary artery de novo lesions with indication for revascularization with a coronary device

Brief summary: A multicentre, observational, prospective device registry, with no control group, designed to evaluate the efficacy and safety of the bioresorbable coronary device, used according to the indications of use, in daily clinical practice in a consecutive number of patients undergoing PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included in the registry.

Detailed description: The patients will be included consecutively at each site for one year. They will be individuals from both sexes, requiring endovascular intervention and meeting the authorised criteria for the indications of use of the device to be used and where dual anti-platelet therapy (DAPT) with aspirin and thienopyridines is considered.

STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary device in patients with de novo coronary artery lesions, where a follow-up of 12 months will be performed.

Primary objective:

MACE rate at 12 months of follow-up:

Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).

Secondary objectives:

* Angina
* Death due to any cause.
* Myocardial infarction of any type (MI: QMI, NQMI, TV, NTV)
* All TLR driven or not by ischaemia
* All TVR driven or not by ischaemia.
* All coronary revascularisations performed (PCI vs CABG)
* Device thrombosis (acute, sub-acute, late) and evidence (definitive, probable, possible).
* Immediate success of the device.
* Immediate success of the procedure.
* Rate of patients with DAPT at \< 1 month, 1-3 months, 3-6 months, and 6-12 months and relationship with the occurrence of events
* Composite endpoints:

Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))

* Rate of overlapping devices: characteristics and relationship with occurrence of events
* Collection of imaging data of the cases where, according to the judgement of the investigator, intravascular imaging tests have been performed (IVUS, OCT).

Eligibility criteria: Inclusion Criteria:

* Patient must be at least 18 years of age at the time of signing the Informed Consent Form
* Patient is to be treated for de novo coronary lesions in a native coronary artery and amenable to receive a bioresorbable device
* The length of the treated lesion should be inferior to the nominal length of the device (12 mm, 18 mm, 28 mm) with a reference vessel diameter \> 2 mm y \< 3,8 mm.
* The patient will not have any relative contraindication for double antiplatelet therapy, with aspirin indefinitely and with a thienopyridine for at least 6 months

Exclusion Criteria:

* Cardiogenic shock
* Left main disease
* Aortocoronary graft
* Intrastent restenosis
* Potentially child-bearing women with no contraceptive methods
* Pregnant or breast-feeding women

Primary outcomes:
measure: MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR
timeFrame: Clinical follow-up at 12 months
Secondary outcomes:
measure: Immediate success of the device/procedure
timeFrame: 1 day
measure: Cardiac death
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
measure: Scaffold/Stent Thrombosis: Timing and Evidence
timeFrame: 12 months
measure: Target lesion/vessel revascularization (TLR/TVR)
timeFrame: 12 months
measure: Angina Events
timeFrame: 12 months
measure: Rate of patients with DAPT at 12 months
timeFrame: 12 months
measure: Rate of overlapping devices and characteristics
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
Study officials:
affiliation: Seccion Hemodinamica y Cardiologia Intervencionista
name: Felipe Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: