Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1520 participants
OBSERVATIONAL
2013-05-31
2021-05-31
Brief Summary
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Detailed Description
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Although the use of BVS is very promising in younger patients with one or more of the above characteristics, evidence of benefit is not available.
The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists who are interested in assessing the results of their interventional practice with BVS, by sharing data.
The BVS-RAI Registry has been created in joint-venture with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri Sud", and is not recipient of funding or benefits originating from the BVS manufacturer or seller. BVS devices are regularly purchased by the participating centres.
Each participating centre is willing to input data of all consecutive patients treated with BVS, with a minimum of 50, and to report on follow-up for at least 5 years. Patient recruitment is not directed per protocol, nor is it rewarded. Patients who give informed consent are included in the BVS-RAI Registry after BVS implant has been performed following the indications, techniques and protocols used in each of the participating institutions.
Baseline patient clinical data, with special attention to biochemistry and drug treatment in patients with diabetes and CKD, as well as angiographic and intravascular imaging data are entered into a web-based Case Report Form.
Follow-up data from outpatient visits or phone interviews, subsequent admissions and coronary angiograms following the protocols being used in each of the participating institutions are prospectively collected and entered into the database.
All data in the CRF is visible to all registered participants at all times. Endpoints are: target lesion and target vessel failure, BVS thrombosis, new revascularisation, myocardial infarction and death. Documentation of those events is required for adjudication by an independent committee.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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PCI with Absorb scaffold
Implantation of biovascular scaffold during PCI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \<75 years
* Patient's informed consent
Exclusion Criteria
75 Years
ALL
No
Sponsors
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Fatebenefratelli and Ophthalmic Hospital
OTHER
Bolognini Hospital
UNKNOWN
Ospedale Regionale di Aosta
UNKNOWN
Ospedali Riuniti di Ancona
UNKNOWN
S. Giacomo Hospital
OTHER
Azienda U.L.S.S n.9 Ospedale di Treviso Ca Foncello
UNKNOWN
Ospedale San Bortolo di Vicenza
OTHER
Azienda Ospedaliera Brotzu
OTHER
San Giuseppe Moscati Hospital
OTHER
Azienda Sanitaria Locale USL 13 Ospedale Mazzoni di Ascoli Piceno
UNKNOWN
S. Andrea Hospital
OTHER
Ospedale Monaldi di Napoli
UNKNOWN
Azienda Ospedaliera di Padova
OTHER
Ospedale della Misericordia di Grosseto
UNKNOWN
Ospedale Santa Corona di Pietra Ligure
UNKNOWN
Istituto Di Ricerche Farmacologiche Mario Negri
OTHER
Ospedale Santa Croce-Carle Cuneo
OTHER
Responsible Party
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Dr Giuseppe Steffenino
MD
Principal Investigators
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Alfonso Ielasi, MD
Role: PRINCIPAL_INVESTIGATOR
AO Seriate
Bernardo Cortese, MD
Role: PRINCIPAL_INVESTIGATOR
AO Fatebenefratelli
Donatella Corrado, PhD
Role: PRINCIPAL_INVESTIGATOR
Istituto Di Ricerche Farmacologiche Mario Negri
Locations
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SSD Emodinamica Dip Cardiovasc ASO S.Croce
Cuneo, , Italy
Countries
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References
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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.
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.
Other Identifiers
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RAI-Registro Absorb Italiano
Identifier Type: -
Identifier Source: org_study_id
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