Italian Absorb Registry

• Conditions: Coronary Artery Disease

• Registration Number: NCT02298413
• Lead Sponsor: Ospedale Santa Croce-Carle Cuneo

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-11-15
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-24
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04
• Primary Completion: 2016-11
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1520

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scaffold thrombosis	1 year	acute, subacute, late and very late
Target lesion revascularization	1 year	ischemia or angiographic-driven

Secondary Outcome Measures

Name	Time	Method
MACE	5 year	Cardiac death, TLR, myocardial infarction

Trial Locations

Locations (1)

SSD Emodinamica Dip Cardiovasc ASO S.Croce; 🇮🇹 Cuneo, Italy