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

Completed

• Conditions: Coronary Artery Disease

• 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

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2010-12
• Study Completion: 2011-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1165

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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 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

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