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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06150872
Other study ID # DUR-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 8, 2024
Est. completion date July 30, 2025

Study information

Verified date January 2024
Source DurVena, Inc.
Contact Laura Eaton-Jankov, APRN, FNP-BC
Phone +1-949-468-9301
Email laura@ultamed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 and secondarily to gain a preliminary understanding of the efficacy of PTP-treated SVGs 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date July 30, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Uzbekistan Republican Scientific Center of Emergency Medical Care Tashkent

Sponsors (1)

Lead Sponsor Collaborator
DurVena, Inc.

Country where clinical trial is conducted

Uzbekistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major cardiac adverse events (MACCE) Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization 30-days
Primary SVG patency Proportion of PTP-treated SVGs with Fitzgibbon I patency score as measured by cardiac computed tomography angiography (CCTA) 6-months
Secondary Major cardiac adverse events (MACCE) Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization 6-months
Secondary Major cardiac adverse events (MACCE) Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization 1-year
Secondary Intimal hyperplasia Plaque + media area (mm^2) as measured by intravenous ultrasound (IVUS) 1-year
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