Photochemical Tissue Passivation Treatment of Saphenous Vein Grafts in CABG

NCT ID: NCT06150872

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2025-03-30

Brief Summary

Early feasibility study of the DurVena Photochemical Tissue Passivation (PTP) device for treatment of saphenous vein grafts in participants undergoing elective coronary artery bypass graft (CABG) surgery. Study to be conducted outside the U.S.

Detailed Description

The Photochemical Tissue Passivation (PTP) treatment of a saphenous vein graft (SVG) is indicated for the reduction of intimal hyperplasia and graft failure rate in SVGs after coronary bypass graft (CABG) surgery. The primary study objective, in this early feasibility study outside the US, is to characterize the safety profile of the PTP device when used during CABG surgery in participants with multivessel atherosclerotic coronary artery disease (CAD).

This is a prospective, randomized, within-subject controlled early feasibility study.

Up to 15 participants with multivessel CAD will be recruited for this study and followed for a minimum of 1 year.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Photochemical tissue passivation group

Photochemical tissue passivation of a saphenous vein graft

Group Type: EXPERIMENTAL

DurVena Photochemical Tissue Passivation

Intervention Type: DEVICE

Treatment of a saphenous vein graft with the DurVena Photochemical Tissue Passivation device.

Standard of care group

Standard of care treatment of a saphenous vein graft

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DurVena Photochemical Tissue Passivation

Treatment of a saphenous vein graft with the DurVena Photochemical Tissue Passivation device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.

2. Age 21 years or older.

3. Planned and scheduled on-pump, arrested heart CABG.

4. Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.

5. IMA graft indicated for the LAD.

6. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 2 mm and adequate vascular bed (without significant distal stenosis), as assessed by pre-operative cardiac angiography and verified by diameter gauging intraoperatively.

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Exclusion Criteria

1. Concomitant non-CABG cardiac surgical procedure.

2. Prior cardiac surgery.

3. Emergency CABG surgery (e.g., cardiogenic shock, inotropic pressure support, intraaortic balloon pump, ECMO).

4. Contraindication for on-pump CABG with cardioplegic arrest (e.g., severely calcified aorta).

5. Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization.

6. Platelets < 50,000/mm3 or other evidence of coagulopathy, INR greater than 1.5 in the absence of anticoagulation therapy.

7. Infection (WBC ≥12.5 x 103/ml and or temperature ≥100.5°F/38°C).

8. History of cerebral vascular accident (CVA) or transient ischemic attacks (TIA) within the last 3 months.

9. Unwilling or unable to receive blood transfusion.

10. Inability to undergo treatment with heparin.

11. Participants on dialysis or GFR of <30 ml/min/1.73m2.

12. Primary liver disease with bilirubin, SGOT, or SGPT > 4X upper limit of normal.

13. Prior history of allergic reaction to contrast media with anaphylaxis or severe peripheral edema.

14. Any medical condition that, in the opinion of the investigator, would compromise the safety of the participant or quality of the study data.

15. Pregnancy and nursing or lactating.

16. Current, or past participation in a clinical trial within the past 30 days.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DurVena, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abdusalom Abdurakhmanov, MD

Role: PRINCIPAL_INVESTIGATOR

Republican Scientific Center of Emergency Medical Care, Uzbekistan

Locations

Republican Scientific Center of Emergency Medical Care

Tashkent, , Uzbekistan

Countries

Uzbekistan

Other Identifiers

DUR-001

Identifier Type: -

Identifier Source: org_study_id