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Coronary Artery DiseaseVCAB-2NCT07078370

Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass

A study testing ATEV with ESS in people with Coronary Artery Disease and Multi Vessel Coronary Artery Disease, run by Vascudyne, Inc. at 4 sites in Poland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 to 75 years
What is being tested?
ATEV with ESS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesPoland
Study dates
28 Aug 2025to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet ALL of the following inclusion criteria:
  • Patient with limited quantity of good quality saphenous vein graft (SVG) for planned operation per the surgeon discretion.
  • Bypass to at least two coronary arteries (CA); primary target shall be an Internal mammary artery (IMA) bypass to the Left anterior descending (LAD) artery, and one IMD to a secondary target CA that:
  • requires ≤ 15cm long conduit
  • has a diameter at least 1.5 mm at targeted landing site
  • has at least 70% stenosis proximal to the target bypass
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  • evidence that sufficient runoff will exist in the target vessel after bypass
  • Male or female patients between the ages of 45 and 75 years inclusive.
  • Elective patient, selected and accepted by the local Heart Team and confirmed by the Sponsor's Screening Committee for an on-pump full sternotomy coronary artery bypass grafting (CABG) surgery.
  • Female subjects must be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).
  • Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
  • Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up cardiac ultrasound and coronary angiogram or computed tomography (CT).
  • Patient is willing to be compliant with prescribed anticoagulant therapy (critical to preventing thrombus in the ATEV).

Who cannot join

  • Patients with left ventricular ejection fraction < 35%.
  • Patients with diffusely diseased coronary arteries suggestive of either poor target quality, or poor vessel runoff.
  • Patients requiring emergency surgery.
  • Patients with cardiogenic shock.
  • Patients with any prior open cardiac surgery such as CABG.
  • Any planned concomitant cardiac surgery, including but not limited to: valve surgery, repair of intracardiac shunt, surgical arrhythmia ablation.
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  • History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation.
  • Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days of the CABG procedure.
  • Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
  • Patient with uncontrolled diabetes (glycated hemoglobin > 8%).
  • Chronic Kidney Disease (CKD) with Glomerular Filtration Rate (GFR) <45 mL/min/1.73m2 (Category: G3b-G5 according to Kidney Disease: Improving Global Outcomes (KDIGO)).
  • Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) <1.5 L/sec or 45% predicted FEV1.
  • Patient with known interstitial lung disease, diagnosed by imaging or pulmonary function tests, including Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO).
  • Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety.
  • Patient on preoperative anticoagulant, or pre existing indication for anticoagulation (e.g. atrial fibrillation, history of thromboembolism), or with known coagulation disorder.
  • Abnormal blood values (e.g. leukopenia, anemia, thrombocytopenia, or thrombocytosis with Platelet Count >400,000 per mL that could influence graft hemostasis or patient recovery
  • Known allergies to study device components: Nitinol, Nickel, Titanium, or agents/medication such as contrast agents, antiplatelet therapy, beta-blocker, or statins required for study assessment or optimal post-CABG medical treatment (hospital standard of care).
  • Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet (clopidogrel, ticagrelor, prasugrel) and factor Xa inhibitor therapy.
  • Any planned medical intervention or condition within the 12 months following ATEV implantation that requires temporary or permanent discontinuation of antiplatelet or anticoagulant therapy.
  • History of heparin-induced thrombocytopenia.
  • Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities.
  • Immunodeficiency including Human Immunodeficiency Virus (HIV), active autoimmune disease, or on immunosuppressant therapy.
  • Treatment with any investigational drug or device within 60 days prior to study entry or ongoing participation in another clinical study of an investigational product.
  • Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance.
  • Has any other condition, in the opinion of the principal investigator, which would put the patient at increased risk from participating in the study or otherwise prevent participation.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Poland4 sites

  • University Clinical Hospital in Poznań

    Poznan

  • University Clinical Hospital No. 2 PUM in Szczecin

    Szczecin

  • Medicover

    Warsaw

  • Military Institute of Medicine - National Research Institute

    Warsaw

Other trials in Poland

About this study

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

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).

Read the 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.

Being tested
ATEV with ESS
Keywords
CABG, ATEV, Tissue Engineered Vessel, coronary artery disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATEV with ESSDevice

    Also called CABG

    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

Study groups in NCT07078370
Study groupRoleWhat they receive
ATEV with ESSExperimentalSurgical implant of Acellular Tissue Engineered Vessel with External Support Structure as Coronary Artery bypass
Receives: Device: ATEV with ESS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful implantation

    Successful implantation as defined by meeting each of the following points:

    1. Completion of both a proximal and distal anastomosis,
    2. Placement of ESS,
    3. No evidence of ATEV twist or kink on direct visual inspection.

    Measured: 30 days.

  2. Freedom from Major Adverse Cardiac and Cerebrovascular events (MACCE) at 30 days.

    Freedom from Major Adverse Cardiac and Cerebrovascular events (MACCE) at 30 days. MACCE is defined as combination of:

    1. death,
    2. non-fatal stroke,
    3. non-fatal myocardial infarction,
    4. unplanned revascularization
    5. hospitalization due to heart failure

    Measured: 30 days.

Secondary outcomes (6)

  1. Patency at 1 and 6 months

    Patency of conduit assessed by Coronary Computed Tomography Angiography (CCTA) results at 1 and 6 months post-implantation.

    Measured: 1 month and 6 months.

  2. Patency at 12 months

    Patency of conduit assessed by angiography results at 12 months, defined according to Fitzgibbon classification.

    Measured: 12 months.

  3. Lumen Diameter Uniformity

    Lumen Diameter Uniformity of all bypasses assessed by angiography results at 12 months.

    Measured: 12 months.

  4. Immune Response

    Panel Reactive Antibody assessment via serum assay at baseline, 1, 6, and 12 months.

    Measured: 12 months.

  5. Device Serious Adverse Event (SAE)

    Device Related Serious Adverse Events identified at 6, 12, 24, 48 and 60 months follow-ups.

    Measured: 6 months, 12 months, 24 months, 48 months, and 60 months.

  6. Freedom from (major adverse cardiac and cerebrovascular events) MACCE

    Freedom from (major adverse cardiac and cerebrovascular events) MACCE at 6, 12, 24, 48 and 60 months follow-ups.

    Measured: 6 months, 12 months, 24 months, 48 months, and 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start28 Aug 2025
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07078370
Sponsor's protocol ID
CIP-004
Acronym
VCAB-2
Status last verified
Jul 2026
First submitted
29 Jun 2025
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ATEV with ESS in people with Coronary Artery Disease and Multi Vessel Coronary Artery Disease, run by Vascudyne, Inc. at 4 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful implantation (time frame: 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07078370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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