Clinical trial NCT06434935: Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
Official title: Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Coronary Artery Disease
Keywords: CABG
Coronary bypass
Lead sponsor: Vascudyne, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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. Life expectancy of at least 4 years.
5. 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).
6. Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
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 investigational device).

Exclusion Criteria:

1. Patients with left ventricular ejection fraction \< 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 hemoglobin test (A1C)\>8.
10. Chronic kidney disease with Glomerular Filtration Rate (GFR) \< 45 militers per minute (mL/min), or active dialysis patients
11. 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).
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 Platelet 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. Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet and factor Xa inhibitor therapy.
20. Immunodeficiency including AIDS / HIV, active autoimmune disease, or on immunosuppressant therapy.
21. 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.
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.

Primary outcomes:
measure: Patency
timeFrame: 6 months
measure: Major Adverse Cardiac and Cerebrovascular events (MACCE)
timeFrame: 30 days
Secondary outcomes:
measure: Patency
timeFrame: 30 days, 12 months, 18 months and 24 months
measure: Fitzgibbon classification
timeFrame: 30 days, 6 months and 12 months
measure: MACCE
timeFrame: 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Sanatario Italiano
Study officials:
affiliation: Italian Hospital Asuncion Paraguay
name: Adrian Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References: