UnknownNot Applicable

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

Austria, Germany2,964 participantsStarted 2016-12-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of Major Adverse Cardiac Events (MACE)

Timeframe: Annually up to 5 years post-CABG Surgery

Trial details

NCT IDNCT02922088

SponsorSomahlution LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-08

View on ClinicalTrials.gov More Cardiovascular Diseases trials