Italian Absorb Registry

Coronary Artery Disease Clinical Trial

— BVS-RAI  

Official title:

Clinical Study on Absorb Polylactic, Reabsorbable Coronary Scaffold (RAI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02298413
• Other study ID #: RAI-Registro Absorb Italiano
• Status: Active, not recruiting
• Phase: N/A
• First received: November 15, 2014
• Last updated: February 3, 2016
• Start date: May 2013
• Est. completion date: May 2021

Study information

• Verified date: February 2016
• Source: Ospedale Santa Croce-Carle Cuneo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1520
• Est. completion date: May 2021
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• Successful implantation of 1 or more coronary BVS

• Age <75 years

• Patient's informed consent

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• PCI with Absorb scaffold
Implantation of biovascular scaffold during PCI

Locations

Country	Name	City	State
Italy	SSD Emodinamica Dip Cardiovasc ASO S.Croce	Cuneo

Sponsors (17)

Lead Sponsor

Collaborator

Ospedale Santa Croce-Carle Cuneo

Azienda Ospedaliera Brotzu, Azienda Ospedaliera di Padova, Azienda Sanitaria Locale USL 13 Ospedale Mazzoni di Ascoli Piceno, Azienda U.L.S.S n.9 Ospedale di Treviso Ca Foncello, Bolognini Hospital, Fatebenefratelli and Ophthalmic Hospital, Istituto di Ricerche Farmacologiche Mario Negri Milano, Ospedale della Misericordia di Grosseto, Ospedale Monaldi di Napoli, Ospedale Regionale di Aosta, Ospedale San Bortolo di Vicenza, Ospedale Santa Corona di Pietra Ligure, Ospedali Riuniti di Ancona, S. Andrea Hospital, S. Giacomo Hospital, San Giuseppe Moscati Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scaffold thrombosis	acute, subacute, late and very late	1 year	Yes
Primary	Target lesion revascularization	ischemia or angiographic-driven	1 year	No
Secondary	MACE	Cardiac death, TLR, myocardial infarction	5 year	No