Status:
UNKNOWN
REPARA Study: REgistry of PAtients With bioResorbable Device in Daily Clinical prActice
Lead Sponsor:
Sección Hemodinamica y Cardiologia Intervencionista
Conditions:
Coronary Artery Lesions With Implantation of Coronary Device
Eligibility:
All Genders
18+ years
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 o...
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 indicat...
Eligibility Criteria
Inclusion
- 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
- Cardiogenic shock
- Left main disease
- Aortocoronary graft
- Intrastent restenosis
- Potentially child-bearing women with no contraceptive methods
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
January 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
2440 Patients enrolled
Trial Details
Trial ID
NCT02256449
Start Date
January 1 2014
End Date
October 1 2016
Last Update
July 18 2016
Active Locations (1)
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1
Hospital 12 de Octubre
Madrid, Madrid, Spain, 28041