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

Active, not recruiting

• Conditions: Cardiovascular Diseases; Coronary Artery Disease

• Registration Number: NCT02922088
• Lead Sponsor: Somahlution LLC

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-10-03
• Study Start: 2016-12-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2964

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Major Adverse Cardiac Events (MACE)	Annually up to 5 years post-CABG Surgery	Rate of Major Adverse Cardiac Events: MACE (a composite of Death, Non-Fatal Myocardial Infarction and Repeat Revascularization. The rate of MACE will be compared to historical controls.

Secondary Outcome Measures

Name	Time	Method
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)	1 month post-CABG Surgery	Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)
Health Economics Outcomes	Annually up to 5 years post-CABG Surgery	Health economic outcome measures will include the following: * The number (n) of major adverse cardiac and cerebrovascular events (MACCE) will be obtained.; * The incidence rate (%) of major adverse cardiac and cerebrovascular events (MACCE) will be obtained; * For death: the mortality rate (%) will be obtained.; * For non-fatal myocardial infarction, repeat revascularization and stroke: the total number of affected patients (n) will be obtained.; * For non-fatal myocardial infarction, repeat revascularization and stroke: the total number of the incidence rate (%) will be obtained.; These outcome measures will be used to obtain the total cost of healthcare resource utilization costs for the treatment of post-operative cardiovascular events.
Quality of life (EQ-5D-5L)	Annually up to 5 years post-CABG Surgery	Quality of life will be measured with EQ-5D-5L (Comprised of 5 questions, each with 5 levels that represent 5 health domains (5D): pain, mood, mobility, self-care and daily activities). This overall self-rated health status will be expressed as an index value.

Trial Locations

Locations (36)

Medical University of Vienna; 🇦🇹 Vienna, Austria

RWTH Aachen University; 🇩🇪 Aachen, Germany

Charité University of Medicine Berlin; 🇩🇪 Berlin, Germany

German Heart Center Berlin; 🇩🇪 Berlin, Germany

Cologne University Heart Center; 🇩🇪 Cologne, Germany

Herzzentrum Dresden; 🇩🇪 Dresden, Germany

University Hospital Essen; 🇩🇪 Essen, Germany

Goethe University Hospital Frankfurt; 🇩🇪 Frankfurt, Germany

University of Giessen; 🇩🇪 Giessen, Germany

Georg August University of Gottingen; 🇩🇪 Göttingen, Germany

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