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

Coronary Artery Disease Clinical Trial

— VASC  

Official title:

European (EU) Multi-Center Registry to Assess Outcomes in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery: Treatment of Vascular Conduits With DuraGraft®, a Novel Endothelial Damage Inhibitor [VASC]

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02922088
• Other study ID #: 005-01
• Status: Active, not recruiting
• Start date: December 9, 2016
• Est. completion date: December 2024

Study information

• Verified date: March 2021
• Source: Somahlution LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2964
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease

Intervention

Device:
• DuraGraft
DuraGraft is a one-time intraoperative vascular graft treatment designed to prevent graft disease and failure and reduce the clinical complications associated with graft failure.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Germany	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	University Medical Center Schleswig-Holstein	Kiel
Germany	Heart Center Leipzig	Leipzig
Germany	University of Lubeck	Lübeck
Germany	University of Marburg	Marburg
Germany	German Heart Center Munich	Muenchen
Germany	Helios Clinic Wuppertal Heart Center	Wuppertal
Ireland	Cork University Hospital	Cork
Ireland	Galway University Hospitals	Galway
Italy	European Hospital	Roma
Spain	Complejo Hospitalario Universitario de Badajoz	Badajoz
Spain	Cruces University Hospital	Barakaldo
Spain	Hospital Universitario Puerto del Mar	Cadiz
Spain	Reina Sofia University Hospital	Córdoba
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario Gregorio Maran?on	Madrid
Spain	Ruber International Hospital	Madrid
Spain	Salamanca University Hospital	Salamanca
Spain	Hospital Universitario De Santiago De Compostela	Santiago De Compostela
Spain	H.U. Virgen del Rocio	Seville
Spain	Hospital Universitario Virgen Macarena	Seville
Switzerland	Cardiocentro Ticino	Lugano
Switzerland	Herzklinik Hirslanden	Zürich
Switzerland	University Hospital of Zurich	Zürich
Turkey	Medical Park Hospital	Antalya
United Kingdom	Victoria Blackpool Hospital	Blackpool
United Kingdom	Golden Jubilee National Hospital (Scotland)	Clydebank

Sponsors (1)

Lead Sponsor	Collaborator
Somahlution LLC

Countries where clinical trial is conducted

Austria,  Germany,  Ireland,  Italy,  Spain,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (3)

Kim FY, Marhefka G, Ruggiero NJ, Adams S, Whellan DJ. Saphenous vein graft disease: review of pathophysiology, prevention, and treatment. Cardiol Rev. 2013 Mar-Apr;21(2):101-9. doi: 10.1097/CRD.0b013e3182736190. Review. — View Citation

Shukla N, Jeremy JY. Pathophysiology of saphenous vein graft failure: a brief overview of interventions. Curr Opin Pharmacol. 2012 Apr;12(2):114-20. doi: 10.1016/j.coph.2012.01.001. Epub 2012 Feb 8. Review. — View Citation

Thatte HS, Biswas KS, Najjar SF, Birjiniuk V, Crittenden MD, Michel T, Khuri SF. Multi-photon microscopic evaluation of saphenous vein endothelium and its preservation with a new solution, GALA. Ann Thorac Surg. 2003 Apr;75(4):1145-52; discussion 1152. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Major Adverse Cardiac Events (MACE)	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.	Annually up to 5 years post-CABG Surgery
Secondary	Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)	Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)	Annually up to 5 years post-CABG Surgery
Secondary	Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)	Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)	1 month post-CABG Surgery
Secondary	Quality of life (EQ-5D-5L)	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.	Annually up to 5 years post-CABG Surgery
Secondary	Health Economics Outcomes	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.	Annually up to 5 years post-CABG Surgery