Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit

NCT06434935 | Enrolling By Invitation Early Phase 1 FDA Drug FDA Device

• 1 other identifier: CIP-003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

CABG; Coronary bypass

Outcome Measures

Primary Outcomes (2)

• Patency

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

  6 months

• 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

  30 days

Secondary Outcomes (3)

• Patency

  30 days, 12 months, 18 months and 24 months

• Fitzgibbon classification

  30 days, 6 months and 12 months

• MACCE

  6, 12, 18 and 24 months

Study Arms (1)

True CABA

EXPERIMENTAL

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

CABA COMBINATION_PRODUCT

Coronary Bypass

True CABA

Eligibility Criteria

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

You may qualify if:

• 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).

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 coronary artery bypass graft (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.
• 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.

Sponsors & Collaborators

• Vascudyne, Inc.: lead

Study Sites (1)

Sanatario Italiano

Asunción, Paraguay

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

• Adrian Ebner, MD

  Italian Hospital Asuncion Paraguay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: June 13, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)