## Protocol Section
### Identification Module
**NCT ID:** NCT06434935

**Acronym:** VCAB-1

**Brief Title:** Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit

**Official Title:** Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit

#### Organization Study ID Info
**ID:** CIP-003
#### Organization
**Class:** INDUSTRY
**Full Name:** Vascudyne, Inc.
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2025-07-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-07

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Vascudyne, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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 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.

### Conditions Module

**Conditions:**

- Coronary Artery Disease

**Keywords:**

- CABG

- Coronary bypass

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Combination Product: CABA

**Label:** True CABA

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- True CABA

**Description:** Coronary Bypass

**Name:** CABA

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Patency

**Time Frame:** 6 months

**Description:** Major Adverse Cardiac and Cerebrovascular events (MACCE)

**Measure:** MACE

**Time Frame:** 30 days

#### Secondary Outcomes

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

**Measure:** Patency

**Time Frame:** 30 days

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

**Measure:** Patency

**Time Frame:** 12 months

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

**Measure:** Patency

**Time Frame:** 18 months

**Description:** Fitzgibbon classification

**Measure:** Fitzgibbon classification

**Time Frame:** 30 days, 6 months and 12 months

**Description:** Freedom from MACCE

**Measure:** MACCE

**Time Frame:** 6, 12, 18 and 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients needing isolated coronary artery bypass grafting to multiple coronary arteries (CA) in which the first target CA must be an arterial bypass and the TRUE CAB target CA must be at least 2mm in diameter, have at least 75% stenosis (\>90% ideal) proximal to the bypass, have at least TIMI II flow (in non-100% stenosis), shall be among the following options: proximal right coronary artery (RCA), Ramus intermedius, left marginal arteries (M1, M2), or diagonal branches (D1, D2). In case of diagonal selection, ensure it will not impact LIMA patency.
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 CT.
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 diffusive coronary artery disease.
3. Patients requiring emergency surgery.
4. Patients with cardiogenic shock.
5. Patients undergoing repeat CABG.
6. Previous, concomitant, and/or planned cardiac procedure including:

   1. heart valve surgery
   2. Percutaneous Coronary Intervention (PCI)
   3. Ablation
   4. Patent Foramen Ovale (PFO) repair
   5. Dor or Maze procedure
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 A1C\>8.
10. Abnormal platelet level defined as Plt Count \>400,000.
11. Severe kidney disease, Glomerular Filtration Rate (GFR) \< 50mL/min, or active dialysis patients
12. Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) \<1.5 lit/sec or 45% predicted FEV1.
13. Patient with underlying interstitial lung disease. Can be assessed via imaging or test like DLCO
14. Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety.
15. Patient on preoperative anticoagulant (i.e. Warfarin).
16. Abnormal blood values (e.g. leukopenia, anemia, or thrombocytopenia) that could influence graft hemostasis or patient recovery.
17. 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).
18. Known need for emergency surgery for any reason and/or intervention/surgery prior to and within 12 months after the CABG surgery that requires antiplatelet therapy discontinuation.
19. History of heparin-induced thrombocytopenia.
20. Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet and factor Xa inhibitor therapy.
21. Immunodeficiency including AIDS / HIV, active autoimmune disease, or on immunosuppressant therapy.
22. 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.
23. Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance.
24. 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.

**Maximum Age:** 75 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Asunción

**Country:** Paraguay

**Facility:** Sanatario Italiano

#### Overall Officials

**Official 1:**

**Affiliation:** Italian Hospital Asuncion Paraguay

**Name:** Adrian Ebner, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

### Misc Info Module

- Version Holder: 2024-05-31
