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Xience V

Phase 3

Coronary Restenosis | Unknown | Cardiovascular |Abbott Laboratories|Last Updated: Sep 6, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment102
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00882219Clinical 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 PeriodPHASE3 COMPLETED 102 — — Mar 1, 2009Jul 1, 2012Sep 6, 20121 France
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Study Endpoints
Primary Endpoints
Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V®
9 months
Secondary Endpoints
Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent
9 months
Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent
9 months
Evaluation by QCA of the in-stent binary restenosis rate
9 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Xience V®EXPERIMENTAL -
Interventions
NameTypeDescription
Xience V®DEVICEPlacement of a Xience V® stent within a restenosed bare metal stent.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 ischemi...

Countries:France
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