Coronary Artery Disease Clinical Trial
Official title:
Early Feasibility Study to Evaluate the Safety and Effectiveness of Photochemical Tissue Passivation (PTP) Treatment of Saphenous Vein Grafts in Participants Undergoing Elective CABG
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Uzbekistan | Republican Scientific Center of Emergency Medical Care | Tashkent |
Lead Sponsor | Collaborator |
---|---|
DurVena, Inc. |
Uzbekistan,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |