Aortic Aneurysm, ThoracicNCT01775046

Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)

An observational study of Aortic Aneurysm, Thoracic and Descending Thoracic Aortic Dissection, run by Medtronic Cardiovascular at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to assess the benefits of endovascular technique in terms of efficacy and safety of Valiant Thoracic Stent Graft with the Captivia Delivery System in the treatment of thoracic aortic disease, in a cohort of patients representative of the population treated under real-life conditions of… Read more about this study

Who is it for?: Any age
Conditions the study is for: Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Penetrating Ulcer
What is being tested?: DTA patients (Valiant)
Type of treatment: Medical device
How many people: 160 participants
Where: 17 sitesFrance
Study dates: 23 Mar 2013to 9 Dec 2021
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: Subjects diagnosed with a disease of descending thoracic aorta (DTA) and requiring endovascular treatment with Stent Graft.

Who may be able to join

Any patient requiring placement of the Valiant Thoracic Stent Graft for the treatment of a disease of his/her descending thoracic aorta.
Patient or holder of parental authority not opposed to the collection and release of the personal information required by the study.
Patient or holder of parental authority has consented for study participation and the Medtronic approved Data Release Form has been signed and personally dated by patient or holder of parental authority and by the investigator.

Who cannot join

Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad).
Prior implantation of a thoracic stent graft.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

France17 sites

CHU Amiens Picardie, Hôpital Sud
Amiens, 80054
CHU de Bordeaux, Groupe Hospitalier Pellegrin
Bordeaux, 33000
Hôpital Henri Mondor
Créteil, 94010
CHU Grenoble, Hôpital A. Michallon
La Tronche, 38700
Hôpital Privé de Parly 2
Le Chesnay, 78150
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350
CHU de Limoges
Limoges, 87042
Hôpital Privé Vert Coteau
Marseille, 13012
Hôpital de la Timone
Marseille, 13385
Hôpital Nord
Marseille, 13915
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Pitié Salpêtrière
Paris, 75651
Clinique Belledonne
Saint-Martin-d'Hères, 38400
CHU de Saint-Etienne, Hôpital Nord
Saint-Priest-en-Jarez, 42270
CHU Rangueil
Toulouse, 31059
Clinique Pasteur
Toulouse, 31076
Clinique du Tonkin
Villeurbanne, 69626

Other trials in France

About this study

Official title: Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases

Read the detailed description

Data regarding the use under routine practice of thoracic aortic stent grafts in France are expected by the French National Authority for Health (HAS). Therefore, in its opinion report from December 22, 2009, HAS makes the maintenance of reimbursement approval of each stent graft dependent on the presentation of results of a specific follow-up study carried out in a cohort of patients representative of the French population treated under real-life conditions of use. This prospective cohort study must involve patients implanted after registration on the LPPR (List of Products and Services qualifying for Reimbursement). The results of the follow-up study must be forwarded to the National Committee for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) for examination once a year. The assessment of this follow-up could lead to the recommendation by CNEDiMTS to continue or stop the reimbursement of the concerned stent graft.

In France, The Valiant Thoracic Stent Graft with the Captivia Delivery System is registered on the LPPR for a period of 3 years since January 12, 2011. In order to comply with HAS expectations, Medtronic Bakken Research Center is setting up this long term non-interventional study on the Valiant Thoracic Stent Graft with the Captivia Delivery System.

Conditions: Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Penetrating Ulcer, Aorta Thoracic; Traumatic Rupture, Aortic Diseases
Being tested: DTA patients (Valiant)
Keywords: Valiant, Captivia, Stent Graft, Thoracic, Aortic
Medical subject headings: Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta, Penetrating Atherosclerotic Ulcer, Aortic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DTA patients (Valiant)Device
Also called TEVAR
Valiant Thoracic Stent Graft Implantation

Study groups in NCT01775046
Study group	Role	What they receive
DTA patients		160 patients presenting with a disease of descending thoracic aorta(DTA)with an indication for endovascular treatment with Valiant Thoracic Stent Graft with the Captivia Delivery System and who meet the inclusion/exclusion criteria are intended to participate in this non-interventional. Receives: Device: DTA patients (Valiant)

What is being measured

The primary outcome is the main question the study is designed to answer.

All-cause mortality
Measured: 5 years

Secondary outcomes (6)

Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site
Measured: Through 5 years
Major Adverse Events
This includes respiratory, neurological, vascular, cardiac, renal, bleeding, visceral and infectious complications and any complication leading to death
Measured: Through 5 years
Conversion to open repair
Measured: Through 5 years
Endovascular or surgical secondary procedures
Measured: Through 5 years
Adverse device effects
Measured: Through 5 years
Thoracic disease-related mortality
Measured: Through 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 20139 Dec 2021

First posted24 Jan 2013 (estimated)
Study start23 Mar 2013
Primary completion21 Jun 2021
Study completion9 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe 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: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01775046
Sponsor's protocol ID: MDTVCFRANCE001
Status last verified: Jan 2022
First submitted: 21 Jan 2013
Last updated: 9 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Only multi center data will be available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
Active, not recruitingObservational study
Pulmonary Complications Following TEVAR
Aortic Aneurysm and Dissection, Thoracic Endovascular Aortic Repair
Recruiting
MBA Early Feasibility Study
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)

All Aortic Aneurysm, Thoracic trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market Study on Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases
ClinicalTrials.gov ID: NCT01775046
Acronym / sponsor ID: MDTVCFRANCE001
Conditions: Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Penetrating Ulcer, Aorta Thoracic; Traumatic Rupture, Aortic Diseases
Keywords: Valiant, Captivia, Stent Graft, Thoracic, Aortic
Study type: Observational
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Study start: 23 Mar 2013 (actual)
Primary completion: 21 Jun 2021 (actual)
Study completion: 9 Dec 2021 (actual)
First posted: 24 Jan 2013 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
DTA patients	–	Device: DTA patients (Valiant)160 patients presenting with a disease of descending thoracic aorta(DTA)with an indication for endovascular treatment with Valiant Thoracic Stent Graft with the Captivia Delivery System and who meet the inclusion/exclusion criteria are intended to participate in this non-interventional.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Subjects diagnosed with a disease of descending thoracic aorta (DTA) and requiring endovascular treatment with Stent Graft.

Key inclusion criteria (3 listed)

Any patient requiring placement of the Valiant Thoracic Stent Graft for the treatment of a disease of his/her descending thoracic aorta.
Patient or holder of parental authority not opposed to the collection and release of the personal information required by the study.
Patient or holder of parental authority has consented for study participation and the Medtronic approved Data Release Form has been signed and personally dated by patient or holder of parental authority and by the investigator.

Key exclusion criteria (2 listed)

Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad).
Prior implantation of a thoracic stent graft.

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
DTA patients (Valiant)Also: TEVARValiant Thoracic Stent Graft Implantation	Device	DTA patients

Primary outcome

All-cause mortality
Time frame: 5 years

6 secondary outcomes

Exclusion of aneurysm, penetrating aortic ulcer (PAU), false lumen or rupture site
Time frame: Through 5 years
Major Adverse Events
Time frame: Through 5 years
Conversion to open repair
Time frame: Through 5 years
Endovascular or surgical secondary procedures
Time frame: Through 5 years
Adverse device effects
Time frame: Through 5 years
Thoracic disease-related mortality
Time frame: Through 5 years

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 9 Feb 2022.
Individual participant dataSharing planned: No. Only multi center data will be available

Related trials for Aortic Aneurysm, Thoracic

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
Active, not recruitingObservational study
Pulmonary Complications Following TEVAR
Aortic Aneurysm and Dissection, Thoracic Endovascular Aortic Repair
Recruiting
MBA Early Feasibility Study
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)

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.

Hervé Rousseau, MD, PhD principal investigator

CHU Rangueil, 1 Avenue Jean Poulhes, TSA 50 032, 31059 TOULOUSE Cedex 9, FRANCE

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Aneurysm, Thoracic and Descending Thoracic Aortic Dissection, run by Medtronic Cardiovascular at 17 sites in France.

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 3 inclusion and 2 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in 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?

All-cause mortality (time frame: 5 years). 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 NCT01775046.

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 9 Feb 2022; AzTrials last refreshed its copy on 26 Oct 2026.