Coronary Artery DiseaseFar XIENCE V®NCT00987506
Evaluation of a XIENCE V® Endoprothesis Used for Coronary Angioplasty, for LPPR (List of Reimbursable Products and Services) Indications in Patients Monitored for 2 Years in France
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 58 sites in France.
Trial summary
The objective of this study is to prepare elements of response to the Haute Autorité de Santé (High Health Authority) of France, which is expecting data relating to the routine use of XIENCE V® endoprothesis within the 5 years following its marketing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- XIENCE V®
- Type of treatment
- Medical device
- How many people
- 1,165 participants
- Where
- 58 sitesFrance
- Study dates
- Jun 2008to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Population Description * Definition: For observational studies only, a description of the population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town).
Who may be able to join
- All patients enrolled in the study must :
- be at least 18;
- be covered by Social Security
- agree to be enrolled in the study (sign the informed consent after reading the information letter).
- In addition, the Xience V endoprothesis implantation must be performed following the LPPR indications here under :
- Treatment of coronary heart disease attributable to de novo lesions (reference vessel with a 2.5 to 3.5 mm) of native coronary arteries, solely in the following groups of patients :
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- patients with diabetes ;
- lesions of small vessels (diameter < 3 mm);
- long lesions (longer than 15 mm) ;
- stenosis of proximal anterior intraventricular septum .
- The use of the Xience V stent is limited to one per patient, except :
- in case of acute occlusive dissection where three stents, maximum, may be covered ;
- for the pluritroncular diabetic patient, in case a bypass is contra-indicated : a stent per artery, with a limit of three per patient, may be covered.
Who cannot join
- Pregnant women
- Patients with:
- a non cardiac vital prognosis endangered during the year following the implantation ;
- less than 72 hours myocardial infarction ;
- lower left ventricular ejection fraction < 30 % ;
- an allergy to the platelets antiaggregant treatment, to heparin, chrome cobalt alloy, or to the angiography contrast medium ;
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- a stenosis of the unprotected common trunk;
- a lesion with calcifications that cannot be pre-dilated;
- a thrombus that can be detected by angiography on the lesion to be treated ;
- an intra-stent re-stenosis.
- Are also excluded :
- patients having had an angioplasty with implantation of an endoprothesis on the same vessel;
- patients having had an angioplasty with implantation of an endoprothesis during the 6 previous months ;
- Patients unable to keep a treatment associating aspirin and thiénopyridines for at least 6 months;
- Patients residing abroad or who cannot be monitored according to the modalities of the study ;
- Patients unable to give on their own free will their informed consent ; On the other hand, in absence of clinical validation, the other sub-groups of at risk patients (notably bifurcation lesions and pluritroncular lesions) cannot be considered , taken alone, as indications for the use of Xience V.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
France58 sites
Clinique De L'Europe
Amiens, 80094
CH Universitaire
Angers, 49933
Hopital Prive D'Antony
Antony, 92166
Clinique La Casamance - UCV
Aubagne, 13400
Clinique La Casamance-Vista
Aubagne, 13400
Clnique Rhone-Durance
Avignon, 84082
Clinique LaFourcade
Bayonne, 64100
CH Jean Minjoz
Besançon, 25030
Polyclinique Du Bois Bernard
Bois-Bernard, 62320
CH Jacques Coeur
Bourges, 18016
Hôpital de la Cavale Blanche-CHU
Brest, 29609
CH Prive Saint-Martin
Caen, 14050
Hopital Albert Schweitzer
Colmar
Clinique Des Cedres
Cornebarrieu, 31700
Polyclinique Louis Pasteur
Essey-lès-Nancy, 54270
Centre Cardiologique D'Evecquemont
Évecquemont, 78740
CH Saint Louis
La Rochelle, 17019
CH DE Lagny- Marne La Valee
Lagny-sur-Marne, 77405
CMC De Parly II
Le Chesnay, 78150
Polyclinique Du Bois
Lille, 59003
CH ST Joseph St. Luc
Lyon, 69007
Clinique Generale De Marignane
Marignane, 13700
Centre Cardio-Vasculaire Valmante
Marseille, 13012
CH Prive Beauregard
Marseille, 13012
Institut Hospitalier Jacques Cartier
Massy, 91300
Clinique Les Fontaines
Melun, 77007
Clinique Du Millenaire
Montpellier, 34960
Hopital Emile Muller
Mulhouse, 68051
NCN-Nouvelles Cliniques Nantaises
Nantes, 44277
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200
Hopital Prive Les Franciscaines
Nîmes, 30104
Polyclinique les Fleurs
Ollioules, 83192
Institut Mutualiste Montsouris
Paris, 75014
Association Clinique Bizet
Paris, 75116
Hôpital Européen Georges Pompidou
Paris, Cedex 15
Clinique Saint-Pierre
Perpignan, 66012
CH General Marechal Joffre
Perpignan, 66046
Clinicque St. Martin
Pessac, 33600
Polyclinique de Poitiers
Poitiers, 86035
Hopital Claude Gallien - ICPS
Quincy-sous-Sénart, 91480
Polyclinique St. Laurent
Rennes, 35018
Hopital Pontchaillou
Rennes, 35033
Hopital Charles Nicolle-CHU
Rouen, 76031
C.M.C.O De La Cote D'Opale
Saint Martin Les Boulogne, 62222
Centre Cardilogique du Nord
Saint-Denis, 93200
Clinique De L'Orangerie
Strasbourg, 67000
Hopital Foch
Suresnes, 92150
Clinique De L'Ormeau-CCV Des Pyrenees
Tarbes, 65000
Clinique Pasteur
Toulouse, 31000
Clinque Pasteur
Toulouse, 31000
Clinique Pasteur
Toulouse, 31076
Hopital De Rangueil - CHU
Toulouse, 31403
Clinique Saint Gatien
Tours, 37000
Centre Hospitalier De Valenciennes
Valenciennes, 59300
Polyclinique De Vauban
Valenciennes, 59300
Hopital de Brabois_CHU Nancy
Vandœuvre-lès-Nancy, 54500
CH Bretagne Atlantique
Vannes, 56017
Clinique Du Tonkin
Villeurbanne, 69100
About this study
The objective of this study is to prepare elements of response to the Haute Autorité de Santé (High Health Authority) of France, which is expecting data relating to the routine use of XIENCE V® endoprothesis within the 5 years following its marketing.
- Conditions
- Coronary Artery Disease
- Being tested
- XIENCE V®
- Keywords
- drug eluting stents, Stents, Angioplasty, Chronic coronary occlusion, Stent thrombosis, Vascular disease, Myocardial ischemia, Coronary artery stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Medical subject headings
- Coronary Artery Disease, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE V®Device
Participants with placement of a XIENCE V® EESS
| Study group | Role | What they receive |
|---|---|---|
| XIENCE V® | Participants receiving XIENCE V® EESS Receives: Device: XIENCE V® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence rate of new revascularisation (by a new angioplasty or coronary bypass) of the lesion(s) that had received the XIENCE V® endoprothesis, one year after its implantation.
Measured: 1 year
Secondary outcomes (5)
Determine the occurrence rate of new revascularisation(s) after endoprothesis implantation
Measured: 18 and 24 months
Determine the occurrence rate of Major Cardiac Events
Measured: 6, 12, 18 and 24 months
Determine the occurrence rate of stent thrombosis as defined by the Academic Research Consortium
Measured: 6, 12, 18 and 24 months
The occurrence rate of death of cardiac origin
Measured: 6, 12, 18 and 24 months
Determine the occurrence rate of myocardial infarction
Measured: 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 2011
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.
- More trials run by Abbott Medical DevicesThe 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
- 1,165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier Blanchard, MD, Principal investigator, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987506
- Sponsor's protocol ID
- F330702
- Acronym
- Far XIENCE V®
- Status last verified
- Apr 2012
- First submitted
- 30 Sep 2009
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a XIENCE V® Endoprothesis Used for Coronary Angioplasty, for LPPR (List of Reimbursable Products and Services) Indications in Patients Monitored for 2 Years in France
- ClinicalTrials.gov ID
- NCT00987506
- Acronym / sponsor ID
- Far XIENCE V® / F330702
- Conditions
- Coronary Artery Disease
- Keywords
- drug eluting stents, Stents, Angioplasty, Chronic coronary occlusion, Stent thrombosis, Vascular disease, Myocardial ischemia, Coronary artery stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,165 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Oct 2009 (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.
The objective of this study is to prepare elements of response to the Haute Autorité de Santé (High Health Authority) of France, which is expecting data relating to the routine use of XIENCE V® endoprothesis within the 5 years following its marketing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XIENCE V® | – | Device: XIENCE V®Participants receiving XIENCE V® EESS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population Description * Definition: For observational studies only, a description of the population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town).
Key inclusion criteria (13 listed)
- be at least 18;
- be covered by Social Security
- agree to be enrolled in the study (sign the informed consent after reading the information letter).
- In addition, the Xience V endoprothesis implantation must be performed following the LPPR indications here under :
- Treatment of coronary heart disease attributable to de novo lesions (reference vessel with a 2.5 to 3.5 mm) of native coronary arteries, solely in the following groups of patients :
Key exclusion criteria (16 listed)
- Pregnant women
- Patients with:
- patients having had an angioplasty with implantation of an endoprothesis on the same vessel;
- patients having had an angioplasty with implantation of an endoprothesis during the 6 previous months ;
- Patients unable to keep a treatment associating aspirin and thiénopyridines for at least 6 months;
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 |
|---|---|---|
| XIENCE V®Participants with placement of a XIENCE V® EESS | Device | XIENCE V® |
Primary outcome
Occurrence rate of new revascularisation (by a new angioplasty or coronary bypass) of the lesion(s) that had received the XIENCE V® endoprothesis, one year after its implantation.
Time frame: 1 year
5 secondary outcomes
Determine the occurrence rate of new revascularisation(s) after endoprothesis implantation
Time frame: 18 and 24 months
Determine the occurrence rate of Major Cardiac Events
Time frame: 6, 12, 18 and 24 months
Determine the occurrence rate of stent thrombosis as defined by the Academic Research Consortium
Time frame: 6, 12, 18 and 24 months
The occurrence rate of death of cardiac origin
Time frame: 6, 12, 18 and 24 months
Determine the occurrence rate of myocardial infarction
Time frame: 6, 12, 18 and 24 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 19 Apr 2012.
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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.
Didier Blanchard, MD principal investigator
Hôpital Européen Georges-Pompidou
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 58 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 13 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: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 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?
Occurrence rate of new revascularisation (by a new angioplasty or coronary bypass) of the lesion(s) that had received the XIENCE V® endoprothesis, one year after its implantation. (time frame: 1 year). 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 19 Apr 2012.