Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 1165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: 1 year
Secondary outcomes:
measure: Determine the occurrence rate of new revascularisation(s) after endoprothesis implantation
timeFrame: 18 and 24 months
measure: Determine the occurrence rate of Major Cardiac Events
timeFrame: 6, 12, 18 and 24 months
measure: Determine the occurrence rate of stent thrombosis as defined by the Academic Research Consortium
timeFrame: 6, 12, 18 and 24 months
measure: The occurrence rate of death of cardiac origin
timeFrame: 6, 12, 18 and 24 months
measure: Determine the occurrence rate of myocardial infarction
timeFrame: 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: Amiens Cedex 03
country: France
facility: Clinique De L'Europe
city: Angers Cedex 9
country: France
facility: CH Universitaire
city: Antony
country: France
facility: Hopital Prive D'Antony
city: Aubagne
country: France
facility: Clinique La Casamance - UCV
city: Aubagne
country: France
facility: Clinique La Casamance-Vista
city: Avignon cedex 2
country: France
facility: Clnique Rhone-Durance
city: Bayonne
country: France
facility: Clinique LaFourcade
city: Besancon Cedex
country: France
facility: CH Jean Minjoz
city: Bois Bernard
country: France
facility: Polyclinique Du Bois Bernard
city: Bourges Cedex
country: France
facility: CH Jacques Coeur
city: Brest Cedex
country: France
facility: Hôpital de la Cavale Blanche-CHU
city: Caen Cedex
country: France
facility: CH Prive Saint-Martin
city: Colmar Cedex
country: France
facility: Hopital Albert Schweitzer
city: Cornebarrieu
country: France
facility: Clinique Des Cedres
city: Essey les Nancy
country: France
facility: Polyclinique Louis Pasteur
city: Evecquemont
country: France
facility: Centre Cardiologique D'Evecquemont
city: La Rochelle Cedex 01
country: France
facility: CH Saint Louis
city: Lagny Sur Marne Cedex
country: France
facility: CH DE Lagny- Marne La Valee
city: Le Chesnay
country: France
facility: CMC De Parly II
city: Lille Cedex
country: France
facility: Polyclinique Du Bois
city: Lyon
country: France
facility: CH ST Joseph St. Luc
city: Marignane
country: France
facility: Clinique Generale De Marignane
city: Marseille
country: France
facility: Centre Cardio-Vasculaire Valmante
city: Marseille
country: France
facility: CH Prive Beauregard
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Melun
country: France
facility: Clinique Les Fontaines
city: Montpellier Cedex 2
country: France
facility: Clinique Du Millenaire
city: Mulhouse
country: France
facility: Hopital Emile Muller
city: Nantes Cedex 2
country: France
facility: NCN-Nouvelles Cliniques Nantaises
city: Neuilly Sur Seine
country: France
facility: Clinique Ambroise Pare
city: Nimes
country: France
facility: Hopital Prive Les Franciscaines
city: Ollioules
country: France
facility: Polyclinique les Fleurs
city: Paris Cedex 16
country: France
facility: Association Clinique Bizet
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Perpignan Cedex
country: France
facility: Clinique Saint-Pierre
city: Perpignan Cedex
country: France
facility: CH General Marechal Joffre
city: Pessac
country: France
facility: Clinicque St. Martin
city: Poitiers Cedex
country: France
facility: Polyclinique de Poitiers
city: Quincy Sous Senart
country: France
facility: Hopital Claude Gallien - ICPS
city: Rennes Cedex 7
country: France
facility: Polyclinique St. Laurent
city: Rennes Cedex
country: France
facility: Hopital Pontchaillou
city: Rouen Cedex
country: France
facility: Hopital Charles Nicolle-CHU
city: Saint-Denis
country: France
facility: Centre Cardilogique du Nord
city: ST Martin Les Boulogne
country: France
facility: C.M.C.O De La Cote D'Opale
city: Strasbourg
country: France
facility: Clinique De L'Orangerie
city: Suresnes
country: France
facility: Hopital Foch
city: Tarbes
country: France
facility: Clinique De L'Ormeau-CCV Des Pyrenees
city: Toulouse Cedex 3
country: France
facility: Clinque Pasteur
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Hopital De Rangueil - CHU
city: Tours
country: France
facility: Clinique Saint Gatien
city: Valenciennes
country: France
facility: Centre Hospitalier De Valenciennes
city: Valenciennes
country: France
facility: Polyclinique De Vauban
city: VanDoeuvre-Les-Nancy
country: France
facility: Hopital de Brabois_CHU Nancy
city: Vannes Cedex
country: France
facility: CH Bretagne Atlantique
city: Villeurbanne
country: France
facility: Clinique Du Tonkin
Study officials:
affiliation: Hôpital Européen Georges-Pompidou
name: Didier Blanchard, MD
role: PRINCIPAL_INVESTIGATOR
References: