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

Withdrawn

• Conditions: coronary artery disease; atherosclerosis coronary arteries; 10011082

• Registration Number: NL-OMON33928
• Lead Sponsor: Gelita Medical BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- the possible occurrence of abnormalities in blood chemistry<br /><br>- the possible occurrence of tamponade</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>