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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922088
Recruitment Status : Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Coronary Artery Disease Device: DuraGraft

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2964 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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]
Actual Study Start Date : December 9, 2016
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : December 2024

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Rate of Major Adverse Cardiac Events (MACE) [ Time Frame: 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 :
  1. Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: Annually up to 5 years post-CABG Surgery ]
    Rate of Major Adverse Cardiac and Cerebrovascular Events: MACCE (a composite of Death, No-Fatal Myocardial Infarction, Repeat Revascularization and Stroke)

  2. Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: 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)

  3. Quality of life (EQ-5D-5L) [ Time Frame: 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.

  4. Health Economics Outcomes [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922088


Locations
Show Show 36 study locations
Sponsors and Collaborators
Somahlution LLC
Investigators
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Principal Investigator: Maximillian Emmert, MD University Hospital, Zürich

Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Somahlution LLC
ClinicalTrials.gov Identifier: NCT02922088    
Other Study ID Numbers: 005-01
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share data to be determined. A Registry Advisory Committee (RAC) will be formed to provide overall scientific direction for the Registry. A publications sub-committee, composed of a subset of the RAC is planned. This sub-committee will be responsible for overseeing the review and approval of all presentations and all publications related to the DuraGraft Registry.
Time Frame: February 2025
Access Criteria: To be determined

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Somahlution LLC:
Vein Graft Failure
Coronary Artery Bypass Graft Surgery
Vascular Grafts
Saphenous Vein Grafts
Vein Graft Disease
Vein Graft Treatment
Vein Graft Handling
Additional relevant MeSH terms:
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Coronary Artery Disease
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases