Coronary Bypass StenosisNCT04127461
Endoscopic Harvesting in Coronary Artery Bypass Grafting.
A study testing Medtronic endoscope in people with Coronary Bypass Stenosis and Graft Infection, run by Dr. Gianluigi Bisleri.
Trial summary
This is a retrospective data collection looking at patients who received either an endoscopic vessel harvesting procedure versus the conventional open procedure. Besides looking at cost variables in the 2 groups, other outcomes of interest include length of hospital stay, rates of infection, medication use… Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Coronary Bypass Stenosis, Graft Infection
- What is being tested?
- Medtronic endoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 773 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2016to 31 Dec 2018
- 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 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any patient at the KHSC undergoing a CABG procedure requiring a vein graft.
Who cannot join
- undergoing a simultaneous procedure.
About this study
Official title: Endoscopic Harvesting of the Radial Artery and Saphenous Vein Grafts in Coronary Artery Bypass Surgery.
This is a retrospective data collection looking at patients who received either an endoscopic vessel harvesting procedure versus the conventional open procedure. Besides looking at cost variables in the 2 groups, other outcomes of interest include length of hospital stay, rates of infection, medication use, re-admissions and compilations.
Read the detailed description
Since April 2018, the study database has been updated with all patients (currently there are 340 patients per group) and variables - both reflecting effectiveness of the procedure and cost. Preoperative variables being captured include comorbidity factors and variables relating to the Society of Thoracic Surgery (STS) score , which is a pre-procedure assessment of surgical risk.
The postoperative data collection includes a variety of complications and comorbidities the patient could experience during their hospital stay. These variables will provide us with information regarding procedure effectiveness, patient recovery and further costs associated with the procedure. Medications and antibiotics provided during the stay are also being captured. Total hospital costs will include any costs associated with ward stay, separated per level of care: Intensive Care Unit (ICU), Cardiac Surgical Unit (CSU), and regular ward.
The two follow up periods are 30 days and 6 months. Both look at the same effectiveness variables, any emergency room (ER) visits, re-admissions, and their respective reasons. Quality of life will be obtained by looking at the number of complications the patient experienced during these periods. The frequency of home care services provided to each patient, if any, are also being tracked. Cost calculations will be done by obtaining the time, length and number of visits to the ER, re-admissions and clinic visits.
- Conditions
- Coronary Bypass Stenosis, Graft Infection
- Being tested
- Medtronic endoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic endoscopeDevice
The endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG.
| Study group | Role | What they receive |
|---|---|---|
| Open vessel harvesting | Active comparator | Arm 1 is the conventional procedure Receives: Device: Medtronic endoscope |
| Medtronic endoscope | Experimental | Arm 2 - is the minimally invasive procedure Receives: Device: Medtronic endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost analysis
economic cost of open versus endoscopic vessel harvesting
Measured: 6 months
Secondary outcomes (2)
Length of stay
days beyond normal length of stay
Measured: 2 days
infection
infection of graft harvesting site
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start3 Sep 2016
- Primary completion20 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bypass StenosisStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Gianluigi Bisleri
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Dr. Gianluigi Bisleri, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127461
- Sponsor's protocol ID
- SURG-400-17
- Status last verified
- Oct 2019
- First submitted
- 24 Sep 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Harvesting of the Radial Artery and Saphenous Vein Grafts in Coronary Artery Bypass Surgery.
- ClinicalTrials.gov ID
- NCT04127461
- Acronym / sponsor ID
- SURG-400-17
- Conditions
- Coronary Bypass Stenosis, Graft Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- Dr. Gianluigi BisleriUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 3 Sep 2016 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Oct 2019 (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.
This is a retrospective data collection looking at patients who received either an endoscopic vessel harvesting procedure versus the conventional open procedure. Besides looking at cost variables in the 2 groups, other outcomes of interest include length of hospital stay, rates of infection, medication use, re-admissions and compilations.
Detailed description
Since April 2018, the study database has been updated with all patients (currently there are 340 patients per group) and variables - both reflecting effectiveness of the procedure and cost. Preoperative variables being captured include comorbidity factors and variables relating to the Society of Thoracic Surgery (STS) score , which is a pre-procedure assessment of surgical risk.
The postoperative data collection includes a variety of complications and comorbidities the patient could experience during their hospital stay. These variables will provide us with information regarding procedure effectiveness, patient recovery and further costs associated with the procedure. Medications and antibiotics provided during the stay are also being captured. Total hospital costs will include any costs associated with ward stay, separated per level of care: Intensive Care Unit (ICU), Cardiac Surgical Unit (CSU), and regular ward.
The two follow up periods are 30 days and 6 months. Both look at the same effectiveness variables, any emergency room (ER) visits, re-admissions, and their respective reasons. Quality of life will be obtained by looking at the number of complications the patient experienced during these periods. The frequency of home care services provided to each patient, if any, are also being tracked. Cost calculations will be done by obtaining the time, length and number of visits to the ER, re-admissions and clinic visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open vessel harvesting | Active comparator | Device: Medtronic endoscopeArm 1 is the conventional procedure |
| Medtronic endoscope | Experimental | Device: Medtronic endoscopeArm 2 - is the minimally invasive procedure |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patient at the KHSC undergoing a CABG procedure requiring a vein graft.
Key exclusion criteria (1 listed)
- undergoing a simultaneous procedure.
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 |
|---|---|---|
| Medtronic endoscopeThe endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG. | Device | Medtronic endoscope, Open vessel harvesting |
Primary outcome
cost analysis
Time frame: 6 months
economic cost of open versus endoscopic vessel harvesting
2 secondary outcomes
Length of stay
Time frame: 2 days
infection
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
Related trials for Coronary Bypass Stenosis
Recruiting
Effect of High-Intensity Interval Training Versus Home-Based Rehabilitation Program On Patients Underwent Coronary Artery Bypass Graft Surgery
Coronary Artery Disease, Coronary Graft Stenosis
Recruiting
Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease
Coronary Artery Stenosis
Recruiting
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
Coronary Artery Disease, Aortic Valve Stenosis
RecruitingObservational study
Coronary CT Angio Evaluating Graft Patency in ACS Patients Treated With DAPT or Single ASA After CABG (CoCAP)
Acute Coronary Syndrome, Coronary Bypass Stenosis
Not yet recruitingObservational study
Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
Coronary Bypass Graft Stenosis, Valvular 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic endoscope in people with Coronary Bypass Stenosis and Graft Infection, run by Dr. Gianluigi Bisleri.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cost analysis (time frame: 6 months). 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 15 Oct 2019.