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

Coronary Restenosis Clinical Trial

— XERES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882219
• Other study ID #: 330704
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2009
• Last updated: September 5, 2012
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• 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
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Device:
• Xience V®
Placement of a Xience V® stent within a restenosed bare metal stent.

Locations

Country	Name	City	State
France	Hopital de Rangueil - Chu	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V®		9 months	Yes
Secondary	Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent		9 months	No
Secondary	Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent		9 months	No
Secondary	Evaluation by QCA of the in-stent binary restenosis rate		9 months	Yes
Secondary	Evaluation of the in-segment binary restenosis rate		9 months	Yes
Secondary	Evaluation by QCA of in-segment late loss		9 months	Yes
Secondary	Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent		9 months	Yes
Secondary	Evaluation by IVUS of the rate of late incomplete apposition		9 months	Yes
Secondary	Document the number of confirmed stent thrombosis		1, 8, 9, 12 and 24 months	Yes
Secondary	-Document the number of confirmed revascularizations (TLR, TVR)		1, 8, 9, 12 and 24 months	Yes
Secondary	Document the rate of MACE		1, 8, 9, 12 and 24 months	Yes