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
NCT ID: NCT00987506
Last Updated: 2012-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1165 participants
OBSERVATIONAL
2008-06-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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XIENCE V®
Participants receiving XIENCE V® EESS
XIENCE V®
Participants with placement of a XIENCE V® EESS
Interventions
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XIENCE V®
Participants with placement of a XIENCE V® EESS
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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 ;
* 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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Didier Blanchard, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Européen Georges-Pompidou
Locations
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Clinique De L'Europe
Amiens, , France
CH Universitaire
Angers, , France
Hopital Prive D'Antony
Antony, , France
Clinique La Casamance - UCV
Aubagne, , France
Clinique La Casamance-Vista
Aubagne, , France
Clnique Rhone-Durance
Avignon, , France
Clinique LaFourcade
Bayonne, , France
CH Jean Minjoz
Besançon, , France
Polyclinique Du Bois Bernard
Bois-Bernard, , France
CH Jacques Coeur
Bourges, , France
Hôpital de la Cavale Blanche-CHU
Brest, , France
CH Prive Saint-Martin
Caen, , France
Hopital Albert Schweitzer
Colmar, , France
Clinique Des Cedres
Cornebarrieu, , France
Polyclinique Louis Pasteur
Essey-lès-Nancy, , France
Centre Cardiologique D'Evecquemont
Évecquemont, , France
CH Saint Louis
La Rochelle, , France
CH DE Lagny- Marne La Valee
Lagny-sur-Marne, , France
CMC De Parly II
Le Chesnay, , France
Polyclinique Du Bois
Lille, , France
CH ST Joseph St. Luc
Lyon, , France
Clinique Generale De Marignane
Marignane, , France
Centre Cardio-Vasculaire Valmante
Marseille, , France
CH Prive Beauregard
Marseille, , France
Institut Hospitalier Jacques Cartier
Massy, , France
Clinique Les Fontaines
Melun, , France
Clinique Du Millenaire
Montpellier, , France
Hopital Emile Muller
Mulhouse, , France
NCN-Nouvelles Cliniques Nantaises
Nantes, , France
Clinique Ambroise Pare
Neuilly-sur-Seine, , France
Hopital Prive Les Franciscaines
Nîmes, , France
Polyclinique les Fleurs
Ollioules, , France
Institut Mutualiste Montsouris
Paris, , France
Association Clinique Bizet
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Clinique Saint-Pierre
Perpignan, , France
CH General Marechal Joffre
Perpignan, , France
Clinicque St. Martin
Pessac, , France
Polyclinique de Poitiers
Poitiers, , France
Hopital Claude Gallien - ICPS
Quincy-sous-Sénart, , France
Polyclinique St. Laurent
Rennes, , France
Hopital Pontchaillou
Rennes, , France
Hopital Charles Nicolle-CHU
Rouen, , France
C.M.C.O De La Cote D'Opale
Saint Martin Les Boulogne, , France
Centre Cardilogique du Nord
Saint-Denis, , France
Clinique De L'Orangerie
Strasbourg, , France
Hopital Foch
Suresnes, , France
Clinique De L'Ormeau-CCV Des Pyrenees
Tarbes, , France
Clinique Pasteur
Toulouse, , France
Clinque Pasteur
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Hopital De Rangueil - CHU
Toulouse, , France
Clinique Saint Gatien
Tours, , France
Centre Hospitalier De Valenciennes
Valenciennes, , France
Polyclinique De Vauban
Valenciennes, , France
Hopital de Brabois_CHU Nancy
Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique
Vannes, , France
Clinique Du Tonkin
Villeurbanne, , France
Countries
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Other Identifiers
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F330702
Identifier Type: -
Identifier Source: org_study_id
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