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Xience V

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

Xience V · 1 trial · 1 indication

Phase 3 1
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 PeriodCoronary Restenosis
COMPLETED102 Analytics
PHASE3COMPLETED
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
NCT00882219102
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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 to 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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Frequently asked questions about Xience V

What is Xience V used for in coronary restenosis?

Xience V is an everolimus-eluting stent used for the treatment of coronary restenosis, specifically in patients with in-stent restenosis in non-coated metallic stents (bare-metal stents). It is designed to be implanted during a percutaneous coronary intervention to help keep the coronary artery open and reduce the recurrence of narrowing.

Who makes Xience V?

Xience V is developed by Abbott Laboratories, a company publicly traded under the ticker symbol ABT. Abbott Laboratories is responsible for the research, development, and clinical evaluation of this everolimus-eluting stent for the treatment of coronary restenosis.

What phase is Xience V in?

Xience V is in Phase 3 clinical development. It is an investigational device, not yet approved by regulatory authorities, and is being evaluated in a completed Phase 3 clinical trial to assess its safety and effectiveness in treating coronary restenosis.

What clinical trials is Xience V in?

Xience V has been studied in one completed Phase 3 clinical trial with the identifier NCT00882219. This trial, conducted in France, enrolled 102 patients aged 18 years and older with coronary restenosis. The study evaluated the stent's performance over a two-year clinical follow-up period.

Is Xience V the same as an everolimus-eluting stent?

Yes, Xience V is an everolimus-eluting stent. It is a drug-eluting stent that releases everolimus, an immunosuppressive agent, to help prevent restenosis. The stent is specifically designed for use in patients with in-stent restenosis in bare-metal stents, as evaluated in the clinical trial.