NCT07078370

Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass

Safety Study of Vascudyne's Small Diameter Acellular Tissue Engineered Vessel (ATEV) for Coronary Artery Bypass

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vascudyne, Inc. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess safety and feasibility of a coronary bypass created with Vascudyne Acellular Tissue Engineered Vessel (ATEV) with External Support Structure (ESS) in patients requiring multi vessel coronary artery bypass grafting (CABG).

Detailed description

Prospective, non-randomized, evaluation clinical study to assess the feasibility of Acellular Tissue Engineered Vessel (ATEV) with External Support Structure (ESS) for secondary coronary targets in patients needing multiple coronary artery bypass. Patients will be implanted with a single ATEV with ESS bypass (single proximal and distal anastomoses) to the second or third coronary arteries (CA) bypass target. The primary target CA shall be bypassed using an arterial graft. The left anterior descending (LAD) CA bypass, if needed, shall be bypassed using the left internal mammary artery (LIMA). A native vessel shall be used for any additional targets as needed.

Conditions

• Coronary Artery Disease
• Multi Vessel Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	ATEV with ESS	Patients will be implanted with a single Acellular Tissue Engineered Vessel with External Support Structure bypass (single proximal and distal anastomoses) to the second or third coronary artery bypass target

Timeline

• Start date: 2025-08-28
• Primary completion: 2027-03-30
• Completion: 2027-07-31
• First posted: 2025-07-22
• Last updated: 2025-12-02

Locations

2 sites across 1 country: Poland

Regulatory

• FDA-regulated device study