Clinical Evaluation of Patients With Everolimus-eluting Stent Xience V® Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period (XERES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00882219
First received: April 14, 2009
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.


Condition Intervention Phase
Coronary Restenosis
Device: Xience V®
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: XERES Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent " Xience V® " Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V® [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Evaluation by QCA of the in-stent binary restenosis rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Evaluation of the in-segment binary restenosis rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Evaluation by QCA of in-segment late loss [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Evaluation by IVUS of the rate of late incomplete apposition [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Document the number of confirmed stent thrombosis [ Time Frame: 1, 8, 9, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • -Document the number of confirmed revascularizations (TLR, TVR) [ Time Frame: 1, 8, 9, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Document the rate of MACE [ Time Frame: 1, 8, 9, 12 and 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xience V® Device: Xience V®
Placement of a Xience V® stent within a restenosed bare metal stent.

  Eligibility

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

Inclusion Criteria:

  • Patients 18 years of age or older
  • Patients affiliated to a social security or equivalent regimen
  • Patients agreeing to participate in the study (Patient with signed informed consent )
  • Patients with evidence of myocardial ischemia (stable or unstable angina, silent ischemia, positive functional exploration or a reversible modification in the ECG consistent with ischemia).
  • Patient acceptable candidate for CABG surgery
  • Patient agreeing to undergo all protocol scheduled follow-up examinations.
  • Patients who tolerate the association Aspirin (dosed 75 to 160 mg/day) and Clopidogrel at 75 mg/day for at least 6 months

Angiographic inclusion criteria:

  • Patient with de novo and sole in-stent restenosis (focal, diffuse or proliferative) in a non-coated metallic stent with or without any other coronary lesions.
  • Patient with target reference vessel diameter between 2.5 and 4 mm by visual estimate
  • Patient with a target lesion ≤ 22mm by visual estimate
  • Patient with a target lesion in an artery with a visual estimate of the restenosis between 50 and 99% and a TIMI flow grade > 1
  • Patient with multiple lesions, the other lesions have been treated with success

Exclusion Criteria:

  • Patient in emergency
  • Patient pregnant
  • Patient nursing
  • Patient unable to give informed consent personally.
  • Patient with myocardial infarction within the previous 72 hours.
  • Patient with limited life expectancy (lesser than 1 year post-inclusion)
  • Patient with unstable arrhythmia
  • Patient with left ventricular ejection fraction (LVEF) lesser than 30%
  • Patient receiver of a cardiac or any other organ transplantation or candidate to an organ transplant
  • Patient who receive or scheduled to receive chemo- or radio- therapy within the 30 days prior to any protocol-related procedure.
  • Patient treated with immunosuppressives or for known immunodepressive or auto-immune pathologies
  • Patient receiving chronically anticoagulant therapy with an INR greater than 2.5
  • Patient with known hypersensitivity or contraindications to anti-platelet drugs, everolimus, heparin, chromium cobalt alloys, nickel, tungsten, acrylic- or fluoro- polymers or sensitivity to angiographic contrast agents.
  • Patient with planned elective surgery requiring the interruption or discontinuation of anti-platelet therapy.
  • Patient with platelet count <100 000/ mm3 or >700 000mm3 ; WBC counts <3 000/mm3 or known or suspected liver disease
  • Patient with severe renal insufficiency (creatinine clearance rate < 30 ml/min), or under dialysis
  • Patient with an history of coagulopathy refusing blood transfusion
  • Patient who had a stroke/cerebrovascular accident or transient cerebrovascular ischemia in the preceding 6 months
  • Patient with urinary or gastro-intestinal bleed in the preceding 6 months
  • Patient with other known serious medical illness or known history of substance abuse (alcohol, drugs) that might result in non-compliance to the investigational plan, or interfere with the results or diminish the life expectancy to less than a year.
  • Patient enrolled in an interventional study with another medical device or drug Angiographic exclusion criteria
  • Patient with in-stent restenosis located on the left main on the coronary by-pass
  • Patient with a lesion of the in-stent restenosis located in a bifurcation including a lateral branch of diameter > 1.5mm
  • Patient with the target vessel totally occluded
  • Patient with a lesion of the restenosis previously treated with another device (with the exception of balloon-tipped catheter) such as a cutting balloon, an atherectomy, laser, brachytherapy or any another medicated stent.
  • Patient with thrombus in the target vessel
  • Patient with aorto-ostiale lesions
  • Patient with previous failures of multiple lesions treated by angioplasty.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882219

Locations
France
Hopital de Rangueil - Chu
Toulouse, France, 31403
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Didier Carrie, MD HOPITAL DE RANGUEIL - CHU
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00882219     History of Changes
Other Study ID Numbers: 330704
Study First Received: April 14, 2009
Last Updated: September 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Abbott Vascular:
Drug eluting stent
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 Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014