Coronary Artery DiseaseNCT06150872
Photochemical Tissue Passivation Treatment of Saphenous Vein Grafts in CABG
A study testing DurVena Photochemical Tissue Passivation in people with Coronary Artery Disease, run by DurVena, Inc. at 1 site in Uzbekistan.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- DurVena Photochemical Tissue Passivation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUzbekistan
- Study dates
- 8 Jan 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Current, or past participation in a clinical trial within the past 30 days.
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site
Republican Scientific Center of Emergency Medical Care
Tashkent
About this study
Official title: Early Feasibility Study to Evaluate the Safety of Photochemical Tissue Passivation (PTP) Treatment of Saphenous Vein Grafts in Participants Undergoing Elective CABG
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.
Read the 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
- Being tested
- DurVena Photochemical Tissue Passivation
- Keywords
- saphenous vein grafts, CABG surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurVena Photochemical Tissue PassivationDevice
Treatment of a saphenous vein graft with the DurVena Photochemical Tissue Passivation device.
| Study group | Role | What they receive |
|---|---|---|
| Photochemical tissue passivation group | Experimental | Photochemical tissue passivation of a saphenous vein graft Receives: Device: DurVena Photochemical Tissue Passivation |
| Standard of care group | No intervention | Standard of care treatment of a saphenous vein graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiac adverse events (MACCE)
Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization
Measured: 30-days
Secondary outcomes (2)
Major cardiac adverse events (MACCE)
Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization
Measured: 6-months
Major cardiac adverse events (MACCE)
Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start8 Jan 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DurVena, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abdusalom Abdurakhmanov, MD, Principal investigator, Republican Scientific Center of Emergency Medical Care, Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150872
- Sponsor's protocol ID
- DUR-001
- Status last verified
- Oct 2024
- First submitted
- 20 Nov 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study to Evaluate the Safety of Photochemical Tissue Passivation (PTP) Treatment of Saphenous Vein Grafts in Participants Undergoing Elective CABG
- ClinicalTrials.gov ID
- NCT06150872
- Acronym / sponsor ID
- DUR-001
- Conditions
- Coronary Artery Disease
- Keywords
- saphenous vein grafts, CABG surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- DurVena, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photochemical tissue passivation group | Experimental | Device: DurVena Photochemical Tissue PassivationPhotochemical tissue passivation of a saphenous vein graft |
| Standard of care group | No intervention | –Standard of care treatment of a saphenous vein graft |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurVena Photochemical Tissue PassivationTreatment of a saphenous vein graft with the DurVena Photochemical Tissue Passivation device. | Device | Photochemical tissue passivation group |
Primary outcome
Major cardiac adverse events (MACCE)
Time frame: 30-days
Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization
2 secondary outcomes
Major cardiac adverse events (MACCE)
Time frame: 6-months
Major cardiac adverse events (MACCE)
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdusalom Abdurakhmanov, MD principal investigator
Republican Scientific Center of Emergency Medical Care, Uzbekistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DurVena Photochemical Tissue Passivation in people with Coronary Artery Disease, run by DurVena, Inc. at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiac adverse events (MACCE) (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.