EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC]

Somahlution

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Cardiovascular Diseases

Treatments: Device: DuraGraft

Study type: Observational

Funder types: Industry

Identifiers

NCT02922088

005-01

Details and patient eligibility

About

The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose vascular grafts have been treated with DuraGraft. All participating sites will be from countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes and patient reported quality of life over a period of 5 years.

Full description

Objectives:

(i) To evaluate the Safety and Performance of DuraGraft®

(ii) To characterize the use of DuraGraft and the outcomes of patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iii) To further characterize the incidence of MACCE outcomes associated with CABG in patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iv) To compare the use of DuraGraft among hospitals and practices

(v) To obtain patient reported quality of life information

(vi) To obtain important health economics outcomes

Enrollment: 2,964 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts
• Patient is ≥18 years of age
• Patient (or a legally authorized representative) is willing and able to provide consent
• DuraGraft is being used for the CABG procedure

Exclusion criteria

• Participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment