Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass

NCT07078370 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: CIP-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Coronary Artery Disease; Multi Vessel Coronary Artery Disease

Keywords

CABG; ATEV; Tissue Engineered Vessel; coronary artery disease

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days.

• 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

  30 days.

Secondary Outcomes (6)

• Patency at 1 and 6 months

  1 month and 6 months.

• Patency at 12 months

  12 months.

• Lumen Diameter Uniformity

  12 months.

• Immune Response

  12 months.

• Device Serious Adverse Event (SAE)

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

Study Arms (1)

ATEV with ESS

EXPERIMENTAL

Surgical implant of Acellular Tissue Engineered Vessel with External Support Structure as Coronary Artery bypass

Device: ATEV with ESS

Interventions

ATEV with ESS DEVICE

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

Also known as: CABG

ATEV with ESS

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with limited quantity of good quality saphenous vein graft (SVG) for planned operation per the surgeon discretion.
• Bypass to at least three coronary arteries (CA); primary target shall be an Interior mesenteric artery (IMA) bypass to the Left anterior descending (LAD) artery, at least one SVG to a secondary CA target, and one Acellular Tissue Engineered Vessel (ATEV) 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
• has at least Thrombolysis in Myocardial Infarction (TIMI) flow grade II
• 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.
• Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
• 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).

You may not qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• Vascudyne, Inc.: lead
• KCRI: collaborator

Study Sites (2)

University Clinical Hospital No. 2 PUM in Szczecin

Szczecin, Poland

Location

Medicover

Warsaw, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Krzysztof Wrobel, MD PhD

  MEDICOVER SP Z O.O.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 29, 2025
• First Posted: July 22, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)