This trial is active, not recruiting.

Condition coronary artery disease
Treatment pci with absorb scaffold
Sponsor Ospedale Santa Croce-Carle Cuneo
Collaborator Fatebenefratelli and Ophthalmic Hospital
Start date May 2013
End date November 2016
Trial size 1520 participants
Trial identifier NCT02298413, RAI-Registro Absorb Italiano


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Scaffold thrombosis
time frame: 1 year
Target lesion revascularization
time frame: 1 year

Secondary Outcomes

time frame: 5 year

Eligibility Criteria

Male or female participants up to 75 years old.

Inclusion Criteria: - Successful implantation of 1 or more coronary BVS - Age <75 years - Patient's informed consent Exclusion Criteria:

Additional Information

Official title Clinical Study on Absorb Polylactic, Reabsorbable Coronary Scaffold (RAI)
Principal investigator Alfonso Ielasi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Ospedale Santa Croce-Carle Cuneo.