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®)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00987506
First received: September 30, 2009
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: XIENCE V®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the occurrence rate of new revascularisation(s) after endoprothesis implantation [ Time Frame: 18 and 24 months ] [ Designated as safety issue: Yes ]
  • Determine the occurrence rate of Major Cardiac Events [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • Determine the occurrence rate of stent thrombosis as defined by the Academic Research Consortium [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • The occurrence rate of death of cardiac origin [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
  • Determine the occurrence rate of myocardial infarction [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 1165
Study Start Date: June 2008
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
XIENCE V®
Participants receiving XIENCE V® EESS
Device: XIENCE V®
Participants with placement of a XIENCE V® EESS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987506

  Show 58 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Didier Blanchard, MD Hôpital Européen Georges Pompidou
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00987506     History of Changes
Other Study ID Numbers: F330702
Study First Received: September 30, 2009
Last Updated: April 17, 2012
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Abbott Vascular:
drug eluting stents
Stents
Angioplasty
Chronic coronary occlusion
Stent thrombosis
Vascular disease
Myocardial ischemia
Coronary artery stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014