NCT06434935

Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Vascudyne, Inc. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The Vascudyne Coronary Artery Bypass Study (VCAB-1) is an initial safety and feasibility study of the Vascudyne, Inc. Coronary Artery Bypass Conduit (CAB A) for bypass of stenosed native coronary arteries in patients undergoing coronary artery bypass surgery.

Detailed description

Prospective, non-randomized, initial evaluation clinical study to assess the feasibility of TRUE CAB for secondary coronary targets in patients needing multiple coronary artery bypass. Patients will be implanted with a single TRUE CAB 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 saphenous vein shall be used for any additional targets as needed. Estimated enrollment for first three patients (2 weeks), followed by enrollment over 4 months. Follow up through 24 months.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CABA	Coronary Bypass

Timeline

• Start date: 2024-06-13
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-05-30
• Last updated: 2025-12-10

Locations

1 site across 1 country: Paraguay

Regulatory

• FDA-regulated drug study
• FDA-regulated device study