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

Coronary Artery Disease Clinical Trial

— Far XIENCE V®  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987506
• Other study ID #: F330702
• Status: Completed
• Phase: N/A
• First received: September 30, 2009
• Last updated: April 17, 2012
• Start date: June 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1165
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• XIENCE V®
Participants with placement of a XIENCE V® EESS

Locations

Country	Name	City	State
France	Clinique De L'Europe	Amiens Cedex 03
France	CH Universitaire	Angers Cedex 9
France	Hopital Prive D'Antony	Antony
France	Clinique La Casamance - UCV	Aubagne
France	Clinique La Casamance-Vista	Aubagne
France	Clnique Rhone-Durance	Avignon cedex 2
France	Clinique LaFourcade	Bayonne
France	CH Jean Minjoz	Besancon Cedex
France	Polyclinique Du Bois Bernard	Bois Bernard
France	CH Jacques Coeur	Bourges Cedex
France	Hôpital de la Cavale Blanche-CHU	Brest Cedex
France	CH Prive Saint-Martin	Caen Cedex
France	Hopital Albert Schweitzer	Colmar Cedex
France	Clinique Des Cedres	Cornebarrieu
France	Polyclinique Louis Pasteur	Essey les Nancy
France	Centre Cardiologique D'Evecquemont	Evecquemont
France	CH Saint Louis	La Rochelle Cedex 01
France	CH DE Lagny- Marne La Valee	Lagny Sur Marne Cedex
France	CMC De Parly II	Le Chesnay
France	Polyclinique Du Bois	Lille Cedex
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 Cedex 2
France	Hopital Emile Muller	Mulhouse
France	NCN-Nouvelles Cliniques Nantaises	Nantes Cedex 2
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	Institut Mutualiste Montsouris	Paris
France	Association Clinique Bizet	Paris Cedex 16
France	CH General Marechal Joffre	Perpignan Cedex
France	Clinique Saint-Pierre	Perpignan Cedex
France	Clinicque St. Martin	Pessac
France	Polyclinique de Poitiers	Poitiers Cedex
France	Hopital Claude Gallien - ICPS	Quincy Sous Senart
France	Hopital Pontchaillou	Rennes Cedex
France	Polyclinique St. Laurent	Rennes Cedex 7
France	Hopital Charles Nicolle-CHU	Rouen Cedex
France	Centre Cardilogique du Nord	Saint-Denis
France	C.M.C.O De La Cote D'Opale	ST Martin Les Boulogne
France	Clinique De L'Orangerie	Strasbourg
France	Hopital Foch	Suresnes
France	Clinique De L'Ormeau-CCV Des Pyrenees	Tarbes
France	Clinique Pasteur	Toulouse
France	Clinique Pasteur	Toulouse
France	Hopital De Rangueil - CHU	Toulouse
France	Clinque Pasteur	Toulouse Cedex 3
France	Clinique Saint Gatien	Tours
France	Centre Hospitalier De Valenciennes	Valenciennes
France	Polyclinique De Vauban	Valenciennes
France	Hopital de Brabois_CHU Nancy	VanDoeuvre-Les-Nancy
France	CH Bretagne Atlantique	Vannes Cedex
France	Clinique Du Tonkin	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Determine the occurrence rate of new revascularisation(s) after endoprothesis implantation		18 and 24 months	Yes
Secondary	Determine the occurrence rate of Major Cardiac Events		6, 12, 18 and 24 months	Yes
Secondary	Determine the occurrence rate of stent thrombosis as defined by the Academic Research Consortium		6, 12, 18 and 24 months	Yes
Secondary	The occurrence rate of death of cardiac origin		6, 12, 18 and 24 months	Yes
Secondary	Determine the occurrence rate of myocardial infarction		6, 12, 18 and 24 months	Yes