Photochemical Tissue Passivation Treatment of Saphenous Vein Grafts in CABG

NCT06150872 | Active Not Recruiting FDA Device

• 1 other identifier: DUR-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

saphenous vein grafts; CABG surgery

Outcome Measures

Primary Outcomes (1)

• Major cardiac adverse events (MACCE)

  Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization

  30-days

Secondary Outcomes (2)

• Major cardiac adverse events (MACCE)

  6-months

• Major cardiac adverse events (MACCE)

  1-year

Study Arms (2)

Photochemical tissue passivation group

EXPERIMENTAL

Photochemical tissue passivation of a saphenous vein graft

Device: DurVena Photochemical Tissue Passivation

Standard of care group

NO INTERVENTION

Standard of care treatment of a saphenous vein graft

Interventions

DurVena Photochemical Tissue Passivation DEVICE

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

Photochemical tissue passivation group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
• Age 21 years or older.
• Planned and scheduled on-pump, arrested heart CABG.
• Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.
• IMA graft indicated for the LAD.
• 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.

You may not qualify if:

• Concomitant non-CABG cardiac surgical procedure.
• Prior cardiac surgery.
• Emergency CABG surgery (e.g., cardiogenic shock, inotropic pressure support, intraaortic balloon pump, ECMO).
• Contraindication for on-pump CABG with cardioplegic arrest (e.g., severely calcified aorta).
• Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization.
• Platelets \< 50,000/mm3 or other evidence of coagulopathy, INR greater than 1.5 in the absence of anticoagulation therapy.
• Infection (WBC ≥12.5 x 103/ml and or temperature ≥100.5°F/38°C).
• History of cerebral vascular accident (CVA) or transient ischemic attacks (TIA) within the last 3 months.
• Unwilling or unable to receive blood transfusion.
• Inability to undergo treatment with heparin.
• Participants on dialysis or GFR of \<30 ml/min/1.73m2.
• Primary liver disease with bilirubin, SGOT, or SGPT \> 4X upper limit of normal.
• Prior history of allergic reaction to contrast media with anaphylaxis or severe peripheral edema.
• Any medical condition that, in the opinion of the investigator, would compromise the safety of the participant or quality of the study data.
• Pregnancy and nursing or lactating.

Sponsors & Collaborators

• DurVena, Inc.: lead

Study Sites (1)

Republican Scientific Center of Emergency Medical Care

Tashkent, Uzbekistan

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

• Abdusalom Abdurakhmanov, MD

  Republican Scientific Center of Emergency Medical Care, Uzbekistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Each subject will have at least 2 saphenous vein grafts. One graft will be randomized to treatment and one graft will be randomized to control. The outcomes assessor will be blinded to which graft has been treated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: January 8, 2024
• Primary Completion: January 30, 2025
• Study Completion: March 30, 2025
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)