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TripleFive Pilot Study investigating the feasibilty and initial safety of the (L)IMA bed application of ACF-Matrix haemostat in 10 CABG patients

TripleFive Pilot Study investigating the feasibilty and initial safety of the (L)IMA bed application of ACF-Matrix haemostat in 10 CABG patients - TripleFive Pilot Study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33928
Enrollment
10
Registered
2009-03-09
Start date
2009-01-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease

Interventions

ACF-Matrix haemostat is a gelatin sponge with haemostatic action and will be applied in the (L)IMA-bed after removal of the "donor" artery.

Sponsors

Gelita Medical BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients 18 years of age or older; - Patients showing signs and symptoms of coronary ischemia and/or stenosis who are clinically fit to undergo a CABG operation; - The investigator is satisfied patients have no other ailments that could prevent patients from finishing the study.

Exclusion criteria

Exclusion criteria: - Patients requiring an acute CABG operation; - Patients partcipating in another clinical trial; - Patients with a local or systemic infection requiring intravenous administration of antibiotics; - Patients with an allergy to porcine products

Design outcomes

Primary

MeasureTime frame
- the possible occurrence of abnormalities in blood chemistry - the possible occurrence of tamponade—

Secondary

MeasureTime frame
n.a.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)