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Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass

NCT07078370 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-02

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • Vascudyne, Inc.

    lead INDUSTRY

Principal Investigators

  • Krzysztof Wrobel, MD PhD · MEDICOVER SP Z O.O.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2027-03-30
Completion
2027-07-31
FDA Device
Yes

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07078370 on ClinicalTrials.gov