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
Far XIENCE V®
1 other identifier
observational
1,165
1 country
58
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Typical duration for all trials
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 19, 2012
April 1, 2012
2.5 years
September 30, 2009
April 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (5)
Determine the occurrence rate of new revascularisation(s) after endoprothesis implantation
18 and 24 months
Determine the occurrence rate of Major Cardiac Events
6, 12, 18 and 24 months
Determine the occurrence rate of stent thrombosis as defined by the Academic Research Consortium
6, 12, 18 and 24 months
The occurrence rate of death of cardiac origin
6, 12, 18 and 24 months
Determine the occurrence rate of myocardial infarction
6, 12, 18 and 24 months
Study Arms (1)
XIENCE V®
Participants receiving XIENCE V® EESS
Interventions
Eligibility Criteria
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).
You may qualify if:
- 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 :
- 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.
You may not qualify if:
- 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 ;
- 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 ;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Clinique De L'Europe
Amiens, 80094, France
CH Universitaire
Angers, 49933, France
Hopital Prive D'Antony
Antony, 92166, France
Clinique La Casamance - UCV
Aubagne, 13400, France
Clinique La Casamance-Vista
Aubagne, 13400, France
Clnique Rhone-Durance
Avignon, 84082, France
Clinique LaFourcade
Bayonne, 64100, France
CH Jean Minjoz
Besançon, 25030, France
Polyclinique Du Bois Bernard
Bois-Bernard, 62320, France
CH Jacques Coeur
Bourges, 18016, France
Hôpital de la Cavale Blanche-CHU
Brest, 29609, France
CH Prive Saint-Martin
Caen, 14050, France
Hopital Albert Schweitzer
Colmar, France
Clinique Des Cedres
Cornebarrieu, 31700, France
Polyclinique Louis Pasteur
Essey-lès-Nancy, 54270, France
Centre Cardiologique D'Evecquemont
Évecquemont, 78740, France
CH Saint Louis
La Rochelle, 17019, France
CH DE Lagny- Marne La Valee
Lagny-sur-Marne, 77405, France
CMC De Parly II
Le Chesnay, 78150, France
Polyclinique Du Bois
Lille, 59003, France
CH ST Joseph St. Luc
Lyon, 69007, France
Clinique Generale De Marignane
Marignane, 13700, France
Centre Cardio-Vasculaire Valmante
Marseille, 13012, France
CH Prive Beauregard
Marseille, 13012, France
Institut Hospitalier Jacques Cartier
Massy, 91300, France
Clinique Les Fontaines
Melun, 77007, France
Clinique Du Millenaire
Montpellier, 34960, France
Hopital Emile Muller
Mulhouse, 68051, France
NCN-Nouvelles Cliniques Nantaises
Nantes, 44277, France
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200, France
Hopital Prive Les Franciscaines
Nîmes, 30104, France
Polyclinique les Fleurs
Ollioules, 83192, France
Institut Mutualiste Montsouris
Paris, 75014, France
Association Clinique Bizet
Paris, 75116, France
Hôpital Européen Georges Pompidou
Paris, Cedex 15, France
Clinique Saint-Pierre
Perpignan, 66012, France
CH General Marechal Joffre
Perpignan, 66046, France
Clinicque St. Martin
Pessac, 33600, France
Polyclinique de Poitiers
Poitiers, 86035, France
Hopital Claude Gallien - ICPS
Quincy-sous-Sénart, 91480, France
Polyclinique St. Laurent
Rennes, 35018, France
Hopital Pontchaillou
Rennes, 35033, France
Hopital Charles Nicolle-CHU
Rouen, 76031, France
C.M.C.O De La Cote D'Opale
Saint Martin Les Boulogne, 62222, France
Centre Cardilogique du Nord
Saint-Denis, 93200, France
Clinique De L'Orangerie
Strasbourg, 67000, France
Hopital Foch
Suresnes, 92150, France
Clinique De L'Ormeau-CCV Des Pyrenees
Tarbes, 65000, France
Clinique Pasteur
Toulouse, 31000, France
Clinque Pasteur
Toulouse, 31000, France
Clinique Pasteur
Toulouse, 31076, France
Hopital De Rangueil - CHU
Toulouse, 31403, France
Clinique Saint Gatien
Tours, 37000, France
Centre Hospitalier De Valenciennes
Valenciennes, 59300, France
Polyclinique De Vauban
Valenciennes, 59300, France
Hopital de Brabois_CHU Nancy
Vandœuvre-lès-Nancy, 54500, France
CH Bretagne Atlantique
Vannes, 56017, France
Clinique Du Tonkin
Villeurbanne, 69100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Didier Blanchard, MD
Hôpital Européen Georges-Pompidou
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2009
First Posted
October 1, 2009
Study Start
June 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
April 19, 2012
Record last verified: 2012-04