Efficacy and Safety of Novel Bidirectional CannulaNCT04402372
Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery
An observational study of Efficacy and Safety of Novel Bidirectional Cannula, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for cardiopulmonary bypass during… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Efficacy and Safety of Novel Bidirectional Cannula
- What is being tested?
- Novel bidirectional cannula (BiflowTM, LivaNova, Italy)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 15 Jun 2020
- Phase
- Observational
- 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 50 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing elective minimally invasive aortic valve replacement
Who may be able to join
- Patient undergoing minimally invasvie aortic valve replacement 50-90 years of age
Who cannot join
- previous vascular surgery of the femoral artery, emergency cardiac surgery including type A aortic dissections, internal diameter of the common femoral artery less than 7.5 mm and where the clinician felt adequate flow rates and line pressures would not be achievable with a 19F cannula, because of the patient's weight and body surface area
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara, 06100
Kanat Ozisik, MD, 90-5052901885, sozisik2002@yahoo.com
About this study
Official title: Comparative Clinical Efficacy of Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery
The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for cardiopulmonary bypass during minimally invasive surgery
Read the detailed description
The femoral artery is a common site for peripheral cannulation in patients requiring cardiopulmonary bypass (CPB) for minimally invasive cardiac surgical procedures (MICS), redo cardiac surgical procedures, and procedures involving the thoracic aorta Limb ischemia is the most common acute and late vascular complication and has been reported in 10% to 70% of patients Traditional methods to maintain distal perfusion include the use of a downstream cannula or sewing on a side graft, but these techniques are cumbersome, time-consuming, and require additional equipment As a result, current practice is relying on the very small volume of blood that will flow around the cannula and collateral circulation to keep the leg viable, but by the time ischemia is clinically evident, irreversible cell damage may have already occurred The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during MICS
- Being tested
- Novel bidirectional cannula (BiflowTM, LivaNova, Italy)
- Keywords
- cannula, cardiopulmonary bypass, bidirectional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel bidirectional cannula (BiflowTM, LivaNova, Italy)Device
We are going to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during minimally invasive surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F bidirectional (BiflowTM, LivaNova, Italy) for femoral artery cannulation Receives: Device: Novel bidirectional cannula (BiflowTM, LivaNova, Italy) | |
| Group 2 | 30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F conventional (HLS, Maquet, Germany cannula with downstream line (6F) for femoral artery cannulation Receives: Device: Novel bidirectional cannula (BiflowTM, LivaNova, Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular complications
infection, emboli, hematoma, bleeding
Measured: one moth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Mar 2020
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Efficacy and Safety of Novel Bidirectional CannulaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Günaydın, Ankara City Hospital Bilkent
- Investigators
- Serdar Gunaydin, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402372
- Sponsor's protocol ID
- 2020-1994
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marasco SF, Tutungi E, Vallance SA, Udy AA, Negri JC, Zimmet AD, McGiffin DC, Pellegrino VA, Moshinsky RA. A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery. Innovations (Phila). 2018 Mar/Apr;13(2):97-103. doi: 10.1097/IMI.0000000000000489.
PubMed 29697598
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Efficacy of Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery
- ClinicalTrials.gov ID
- NCT04402372
- Acronym / sponsor ID
- 2020-1994
- Keywords
- cannula, cardiopulmonary bypass, bidirectional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 26 May 2020 (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.
The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for cardiopulmonary bypass during minimally invasive surgery
Detailed description
The femoral artery is a common site for peripheral cannulation in patients requiring cardiopulmonary bypass (CPB) for minimally invasive cardiac surgical procedures (MICS), redo cardiac surgical procedures, and procedures involving the thoracic aorta Limb ischemia is the most common acute and late vascular complication and has been reported in 10% to 70% of patients Traditional methods to maintain distal perfusion include the use of a downstream cannula or sewing on a side graft, but these techniques are cumbersome, time-consuming, and require additional equipment As a result, current practice is relying on the very small volume of blood that will flow around the cannula and collateral circulation to keep the leg viable, but by the time ischemia is clinically evident, irreversible cell damage may have already occurred The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during MICS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Novel bidirectional cannula (BiflowTM, LivaNova, Italy)30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F bidirectional (BiflowTM, LivaNova, Italy) for femoral artery cannulation |
| Group 2 | – | Device: Novel bidirectional cannula (BiflowTM, LivaNova, Italy)30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F conventional (HLS, Maquet, Germany cannula with downstream line (6F) for femoral artery cannulation |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective minimally invasive aortic valve replacement
Key inclusion criteria (1 listed)
- Patient undergoing minimally invasvie aortic valve replacement 50-90 years of age
Key exclusion criteria (1 listed)
- previous vascular surgery of the femoral artery, emergency cardiac surgery including type A aortic dissections, internal diameter of the common femoral artery less than 7.5 mm and where the clinician felt adequate flow rates and line pressures would not be achievable with a 19F cannula, because of the patient's weight and body surface area
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 |
|---|---|---|
| Novel bidirectional cannula (BiflowTM, LivaNova, Italy)We are going to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during minimally invasive surgery | Device | Group 1, Group 2 |
Primary outcome
Vascular complications
Time frame: one moth
infection, emboli, hematoma, bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Results publication: PubMed 29697598Marasco SF, Tutungi E, Vallance SA, Udy AA, Negri JC, Zimmet AD, McGiffin DC, Pellegrino VA, Moshinsky RA. A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery. Innovations (Phila). 2018 Mar/Apr;13(2):97-103. doi: 10.1097/IMI.0000000000000489.
- Individual participant dataSharing planned: No
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.
Serdar Gunaydin, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy and Safety of Novel Bidirectional Cannula, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 26 May 2020. 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 Turkey (Türkiye). 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?
Contact Serdar Gunaydin, MD (905363896521, serdarkvc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular complications (time frame: one moth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402372, which also lists 1 linked publication.
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 26 May 2020.