Cardiovascular Surgical ProcedureCardioRootNCT01609270
CardioRoot Post-Marketing Surveillance Registry
An observational study of Cardiovascular Surgical Procedure, run by Maquet Cardiovascular at 6 sites in 3 countries.
Trial summary
Post-marketing surveillance registry of the CardioRoot graft. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Surgical Procedure
- What is being tested?
- CardioRoot graft
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Nov 2013to Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with aneurysmal and occlusive disease of the thoracic aorta treated with a CARDIOROOT vascular graft.
Who may be able to join
- patients requiring a CardioRoot graft as per the CardioRoot Instructions for Use (IFU)
Who cannot join
- patients with contra-indications per CardioRoot IFU
- patients requiring consecutive aortic surgery
- patients with coronary artery disease
- patients who require urgent or emergent surgery
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Czechia3 sites
University Hospital Olomouc
Olomouc, 775 20
General University Hospital
Prague, 128 08
University Hospital Motol
Prague, 150 06
Italy2 sites
Ospedale Manzoni di Lecco
Lecco, 23900
Ospedale Luigi Sacco
Milan, 20157
France1 site
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, 33404
About this study
Post-marketing surveillance registry of the CardioRoot graft.
Read the detailed description
Study objective is to monitor the performance and safety of CardioRoot vascular grafts implanted in a thoracic position. Patient survival rates will be monitored as well as immediate and long-term complications.
- Conditions
- Cardiovascular Surgical Procedure
- Being tested
- CardioRoot graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioRoot graftDevice
prospective single arm multi-center study to evaluate CardioRoot grafts implanted in a thoracic position.
| Study group | Role | What they receive |
|---|---|---|
| CardioRoot | All subjects receive the CardioRoot graft at baseline implant procedure. Receives: Device: CardioRoot graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft complications
Complications will be assessed out to one year post implantation.
Measured: 30 days
Graft complications
Complications will be assessed out to one year post implantation.
Measured: 1 year
Secondary outcomes (1)
Subject mortality rate
Subject mortality rate will be followed out to one year post implantation.
Measured: 30 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2017
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 Cardiovascular Surgical ProcedureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maquet Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609270
- Sponsor's protocol ID
- MCV00008317
- Acronym
- CardioRoot
- Status last verified
- Sep 2018
- First submitted
- 25 May 2012
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tasca G, Lindner J, Barandon L, Santavy P, Antona C, Burkert J, Gamba A. Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study. J Cardiothorac Surg. 2019 May 21;14(1):94. doi: 10.1186/s13019-019-0914-y.
PubMed 31113456
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioRoot Post-Marketing Surveillance Registry
- ClinicalTrials.gov ID
- NCT01609270
- Acronym / sponsor ID
- CardioRoot / MCV00008317
- Conditions
- Cardiovascular Surgical Procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Maquet CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Nov 2013 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 31 May 2012 (estimated)
- 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.
Post-marketing surveillance registry of the CardioRoot graft.
Detailed description
Study objective is to monitor the performance and safety of CardioRoot vascular grafts implanted in a thoracic position. Patient survival rates will be monitored as well as immediate and long-term complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CardioRoot | – | Device: CardioRoot graftAll subjects receive the CardioRoot graft at baseline implant procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with aneurysmal and occlusive disease of the thoracic aorta treated with a CARDIOROOT vascular graft.
Key inclusion criteria (1 listed)
- patients requiring a CardioRoot graft as per the CardioRoot Instructions for Use (IFU)
Key exclusion criteria (4 listed)
- patients with contra-indications per CardioRoot IFU
- patients requiring consecutive aortic surgery
- patients with coronary artery disease
- patients who require urgent or emergent surgery
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 |
|---|---|---|
| CardioRoot graftprospective single arm multi-center study to evaluate CardioRoot grafts implanted in a thoracic position. | Device | CardioRoot |
Primary outcome
Graft complications
Time frame: 30 days
Complications will be assessed out to one year post implantation.
Graft complications
Time frame: 1 year
Complications will be assessed out to one year post implantation.
1 secondary outcome
Subject mortality rate
Time frame: 30 days, 1 year
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 17 Sep 2018.
- Derived from this study: PubMed 31113456Tasca G, Lindner J, Barandon L, Santavy P, Antona C, Burkert J, Gamba A. Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study. J Cardiothorac Surg. 2019 May 21;14(1):94. doi: 10.1186/s13019-019-0914-y.
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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.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Surgical Procedure, run by Maquet Cardiovascular at 6 sites in 3 countries.
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 4 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 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Czechia, Italy, France. 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?
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?
Graft complications (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT01609270, 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 17 Sep 2018.