Clinical trial NCT02298413: Italian Absorb Registry
Official title: Clinical Study on Absorb Polylactic, Reabsorbable Coronary Scaffold (RAI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Ospedale Santa Croce-Carle Cuneo
Sponsor class: OTHER
Collaborators: name: Fatebenefratelli and Ophthalmic Hospital
name: Bolognini Hospital
name: Ospedale Regionale di Aosta
name: Ospedali Riuniti di Ancona
name: S. Giacomo Hospital
name: Azienda U.L.S.S n.9 Ospedale di Treviso Ca Foncello
name: Ospedale San Bortolo di Vicenza
name: Azienda Ospedaliera Brotzu
name: San Giuseppe Moscati Hospital
name: Azienda Sanitaria Locale USL 13 Ospedale Mazzoni di Ascoli Piceno
name: S. Andrea Hospital
name: Ospedale Monaldi di Napoli
name: Azienda Ospedaliera di Padova
name: Ospedale della Misericordia di Grosseto
name: Ospedale Santa Corona di Pietra Ligure
name: Istituto Di Ricerche Farmacologiche Mario Negri
First posted: 2014-11-24
Enrollment: 1520
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is an all-comers study, and includes all consecutive patients who have been treated with 1 or more BVS in the study time lapse in each participating centre

Brief summary: The investigators aim at evaluating the long-term (5-year) clinical outcome following Absorb BVS implantation in a real world, all-comers population of consecutive patients, as treated according to the indications, techniques and protocols used in the participating institutions.

Detailed description: Long-term data after implantation of coronary BVS is scarce, especially in subgroups of patients with diabetes or chronic kidney disease, and in those with complex coronary lesions and/or multivessel disease.

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.

Eligibility criteria: Inclusion Criteria:

* Successful implantation of 1 or more coronary BVS
* Age \<75 years
* Patient's informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Scaffold thrombosis
timeFrame: 1 year
measure: Target lesion revascularization
timeFrame: 1 year
Secondary outcomes:
measure: MACE
timeFrame: 5 year
Other outcomes:
Locations:
city: Cuneo
country: Italy
facility: SSD Emodinamica Dip Cardiovasc ASO S.Croce
Study officials:
affiliation: AO Seriate
name: Alfonso Ielasi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AO Fatebenefratelli
name: Bernardo Cortese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Donatella Corrado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.