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Coronary Artery DiseaseEarly Phase 1VCAB-1NCT06434935

Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit

A Early Phase 1 study testing CABA in people with Coronary Artery Disease, run by Vascudyne, Inc. at 1 site in Paraguay.

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

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 more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
CABA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteParaguay
Study dates
13 Jun 2024to Aug 2026
Phase
Early Phase 1
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

  • 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.
  • 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 CABG surgery.
  • Life expectancy of at least 4 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 computerized tomography (CT) scan.
  • Patient is willing to be compliant with prescribed anticoagulant therapy (critical to preventing thrombus in the investigational device).

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 coronary artery bypass graft (CABG).
  • Any planned concomitant cardiac surgery, including but not limited to: valve surgery, repair of intracardiac shunt, surgical arrhythmia ablation.
Show all 23Show fewer
  • 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.
  • Patients with Type 1 Diabetes and Patients with Type II Diabetes having glycate hemoglobin test (A1C)>8.
  • Chronic kidney disease with Glomerular Filtration Rate (GFR) < 45 militers per minute (mL/min), or active dialysis patients
  • Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) <1.5 lit/sec or 45% predicted forced expiratory volume in one second (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 (i.e. Warfarin) or any known intrinsic coagulation disorder.
  • Abnormal blood values (e.g. leukopenia, anemia, thrombocytopenia, or thrombocytosis with Platelet Count >400,000 per militer (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).
  • Any medical intervention or condition within the 12 months following TRUE CAB implantation that requires temporary or permanent discontinuation of anticoagulant therapy.
  • History of heparin-induced thrombocytopenia.
  • Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet and factor Xa inhibitor therapy.
  • Immunodeficiency including AIDS / 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

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

Paraguay1 site

  • Sanatario Italiano

    Asunción

Other trials in Paraguay

About this study

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.

Being tested
CABA
Keywords
CABG, Coronary bypass
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.

  • CABACombination product

    Coronary Bypass

Study groups in NCT06434935
Study groupRoleWhat they receive
True CABAExperimentalPatients will be implanted with a single TRUE CAB bypass (single proximal and distal anastomoses) to the second or third CA bypass target
Receives: Combination Product: CABA

What is being measured

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

  1. Patency

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

    Measured: 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

    Measured: 30 days

Secondary outcomes (3)

  1. Patency

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

    Measured: 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

    Measured: 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

    Measured: 6, 12, 18 and 24 months

Timeline

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

  1. First posted30 May 2024
  2. Study start13 Jun 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06434935
Sponsor's protocol ID
CIP-003
Acronym
VCAB-1
Status last verified
Dec 2025
First submitted
23 May 2024
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CABA in people with Coronary Artery Disease, run by Vascudyne, Inc. at 1 site in Paraguay.

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 8 inclusion and 23 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Paraguay. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Patency (time frame: 6 months). 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 NCT06434935.

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 10 Dec 2025.

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