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
- Conditions
- Coronary Artery Disease
- Interventions
- Device: XIENCE V®
- Registration Number
- NCT00987506
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1165
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.
-
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 ;
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description XIENCE V® XIENCE V® Participants receiving XIENCE V® EESS
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (57)
Clinique De L'Europe
🇫🇷Amiens Cedex 03, France
CH Universitaire
🇫🇷Angers Cedex 9, France
Hopital Prive D'Antony
🇫🇷Antony, France
Clinique LaFourcade
🇫🇷Bayonne, France
CH Jacques Coeur
🇫🇷Bourges Cedex, France
CH DE Lagny- Marne La Valee
🇫🇷Lagny Sur Marne Cedex, France
Polyclinique Du Bois Bernard
🇫🇷Bois Bernard, France
Hôpital de la Cavale Blanche-CHU
🇫🇷Brest Cedex, France
CMC De Parly II
🇫🇷Le Chesnay, France
Clinique Generale De Marignane
🇫🇷Marignane, France
Centre Cardio-Vasculaire Valmante
🇫🇷Marseille, France
Institut Hospitalier Jacques Cartier
🇫🇷Massy, France
CH General Marechal Joffre
🇫🇷Perpignan Cedex, France
Clinique De L'Orangerie
🇫🇷Strasbourg, France
Hopital De Rangueil - CHU
🇫🇷Toulouse, France
CH Prive Beauregard
🇫🇷Marseille, France
Clinique Les Fontaines
🇫🇷Melun, France
Clinique Ambroise Pare
🇫🇷Neuilly Sur Seine, France
Hopital Prive Les Franciscaines
🇫🇷Nimes, France
Polyclinique les Fleurs
🇫🇷Ollioules, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Association Clinique Bizet
🇫🇷Paris Cedex 16, France
Clinique Saint-Pierre
🇫🇷Perpignan Cedex, France
C.M.C.O De La Cote D'Opale
🇫🇷ST Martin Les Boulogne, France
NCN-Nouvelles Cliniques Nantaises
🇫🇷Nantes Cedex 2, France
Hopital Claude Gallien - ICPS
🇫🇷Quincy Sous Senart, France
Hopital Pontchaillou
🇫🇷Rennes Cedex, France
Hopital Foch
🇫🇷Suresnes, France
Clinque Pasteur
🇫🇷Toulouse Cedex 3, France
Polyclinique De Vauban
🇫🇷Valenciennes, France
Clinique Pasteur
🇫🇷Toulouse, France
Clinique La Casamance - UCV
🇫🇷Aubagne, France
Clnique Rhone-Durance
🇫🇷Avignon cedex 2, France
CH Prive Saint-Martin
🇫🇷Caen Cedex, France
Polyclinique Louis Pasteur
🇫🇷Essey les Nancy, France
Centre Cardiologique D'Evecquemont
🇫🇷Evecquemont, France
CH ST Joseph St. Luc
🇫🇷Lyon, France
Hopital Emile Muller
🇫🇷Mulhouse, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Clinicque St. Martin
🇫🇷Pessac, France
Polyclinique de Poitiers
🇫🇷Poitiers Cedex, France
Polyclinique St. Laurent
🇫🇷Rennes Cedex 7, France
Hopital Charles Nicolle-CHU
🇫🇷Rouen Cedex, France
Centre Cardilogique du Nord
🇫🇷Saint-Denis, France
Clinique De L'Ormeau-CCV Des Pyrenees
🇫🇷Tarbes, France
Clinique Saint Gatien
🇫🇷Tours, France
Centre Hospitalier De Valenciennes
🇫🇷Valenciennes, France
CH Bretagne Atlantique
🇫🇷Vannes Cedex, France
Clinique Du Tonkin
🇫🇷Villeurbanne, France
Clinique La Casamance-Vista
🇫🇷Aubagne, France
CH Jean Minjoz
🇫🇷Besancon Cedex, France
Hopital Albert Schweitzer
🇫🇷Colmar Cedex, France
Clinique Des Cedres
🇫🇷Cornebarrieu, France
CH Saint Louis
🇫🇷La Rochelle Cedex 01, France
Polyclinique Du Bois
🇫🇷Lille Cedex, France
Hopital de Brabois_CHU Nancy
🇫🇷VanDoeuvre-Les-Nancy, France
Clinique Du Millenaire
🇫🇷Montpellier Cedex 2, France