ClinicalTrials.gg
Enrolling by invitationNCT06434935VCAB-1Updated Dec 10, 2025

Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit

An Early Phase 1 interventional study of CABA in Coronary Artery Disease, sponsored by Vascudyne, Inc.. Enrolling by invitation at 1 site in Paraguay. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Vascudyne, Inc. · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Phase
Early Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • CABG
  • Coronary bypass
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 5 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Vascudyne, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients needing isolated coronary artery bypass grafting to multiple coronary arteries (CA) in which the first target CA shall be an arterial bypass to the left anterior descending artery (LAD) and the second and potentially third target CA must be at least 2 mm in diameter, have at least 70% stenosis proximal to the bypass, have at least Thrombolysis in Myocardial Infarction (TIMI) II flow, and shall be among the following options: right coronary artery (RCA), right posterior descending artery (PDA), Ramus Intermedius, obtuse marginal arteries (OM), or diagonal branches of the left anterior descending artery.
  2. Male or female patients between the ages of 45 and 75 years inclusive.
  3. Elective patient, selected and accepted by the local Heart Team and confirmed by the Sponsor's Screening Committee for an on-pump full sternotomy CABG surgery.
  4. of at least 4 years.
  5. Female subjects must be of non-, which is defined as (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).
  6. Patient has been informed of the nature of the study, agrees to its provisions, and has provided written .
  7. Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up cardiac ultrasound and coronary angiogram or computerized tomography (CT) scan.
  8. Patient is willing to be compliant with prescribed anticoagulant therapy (critical to preventing thrombus in the device).

Exclusion criteria

Exclusion Criteria:

  1. Patients with \< 35%.
  2. Patients with diffusely diseased coronary arteries suggestive of either poor target quality, or poor vessel runoff.
  3. Patients requiring emergency surgery.
  4. Patients with cardiogenic shock.
  5. Patients with any prior open cardiac surgery such as coronary artery bypass graft (CABG).
  6. Any planned concomitant cardiac surgery, including but not limited to: valve surgery, repair of intracardiac shunt, surgical arrhythmia ablation.
  7. History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation.
  8. Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days of the CABG procedure.
  9. Patients with Type 1 Diabetes and Patients with Type II Diabetes having glycate test ()>8.
  10. Chronic kidney disease with (GFR) \< 45 militers per minute (mL/min), or active dialysis patients
  11. Moderate to severe (COPD) with a forced expiratory volume (FEV) \<1.5 lit/sec or 45% predicted (FEV1).
  12. Patient with known interstitial lung disease, diagnosed by imaging or pulmonary function tests, including diffusing capacity of the lungs for carbon monoxide (DLCO).
  13. Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety.
  14. Patient on preoperative anticoagulant (i.e. Warfarin) or any known intrinsic coagulation disorder.
  15. Abnormal blood values (e.g. leukopenia, anemia, thrombocytopenia, or thrombocytosis with Count >400,000 per militer (mL) that could influence graft hemostasis or patient recovery.
  16. 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).
  17. Any medical intervention or condition within the 12 months following TRUE CAB implantation that requires temporary or permanent discontinuation of anticoagulant therapy.
  18. History of heparin-induced thrombocytopenia.
  19. to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet and factor Xa inhibitor therapy.
  20. Immunodeficiency including AIDS / , active disease, or on therapy.
  21. Treatment with any drug or device within 60 days prior to study entry or ongoing participation in another clinical study of an investigational product.
  22. Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance.
  23. 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.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    True CABA

    Patients will be implanted with a single TRUE CAB bypass (single proximal and distal anastomoses) to the second or third CA bypass target

    Combination Product: CABA

Interventions

  • Combination productCABA

    Coronary Bypass

06

What researchers measure

Primary outcomes

  1. Patency

    Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].

    Time frame: 6 months

  2. Major Adverse Cardiac and Cerebrovascular events (MACCE)

    Freedom from MACCE; includes adverse events; death, non-fatal myocardial infraction, non-fatal stroke, unplanned revascularization, and hospitalization due to heart failure

    Time frame: 30 days

Secondary outcomes

  1. Patency

    Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].

    Time frame: 30 days, 12 months, 18 months and 24 months

  2. Fitzgibbon classification

    Fitzgibbon classification is a grading system for coronary artery bypass grafts (CABGs) that use saphenous vein grafts (SVGs) and arterial grafts to treat severe coronary artery disease. The scale assesses the following characteristics: Fitzgibbon I patency (perfect patency) with no lumen irregularities. Fitzgibbon II patency with lumen irregularities that involve less than 50% of SVG length. Fitzgibbon III patency with lumen irregularities that involve more than 50% of SVG length

    Time frame: 30 days, 6 months and 12 months

  3. MACCE

    Freedom from MACCE includes adverse events; death, non-fatal myocardial infraction, non-fatal stroke, unplanned revascularization, and hospitalization due to heart failure

    Time frame: 6, 12, 18 and 24 months

07

Study locations

1 site
  • Sanatario Italiano
    Asunción, Paraguay
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Aug 2026, 26 months after the start.

Of 34 phase 1 interventional studies under Coronary Artery Disease, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 26 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2024
First posted
May 30, 2024
StartActual
Jun 13, 2024
Primary completionEst.
Aug 2026
CompletionEst.
Aug 2026
Last update
Dec 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06434935
Lead sponsor
Vascudyne, Inc.
Responsible party
Sponsor
First posted
May 30, 2024
Start date
Jun 13, 2024
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Dec 10, 2025

Study contacts

Adrian Ebner, MD
principal investigator · Italian Hospital Asuncion Paraguay

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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