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 (Far XIENCE V®)

Abbott

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: XIENCE V®

Study type: Observational

Funder types: Industry

Identifiers

NCT00987506

F330702

Details and patient eligibility

About

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.

Enrollment: 1,165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,165 participants in 1 patient group

XIENCE V®

Description:

Participants receiving XIENCE V® EESS

Treatment:

Device: XIENCE V®