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Anti-platelet therapy

Phase 3

Iliac Artery Stenosis | Small molecule | Cardiovascular |Boston Scientific Corporation|Last Updated: May 7, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment125

FDA Designations

No designations recorded

Clinical trial landscape

Anti-platelet therapy · 1 trial · 1 indication

Phase 3 1
NCT00896337EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac ArteriesIliac Artery Stenosis
COMPLETED125 Analytics
PHASE3COMPLETED
EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
Iliac Artery StenosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Device- and/or Procedure-related Major Adverse Events (MAE)
9 Months

MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months

Secondary Endpoints

Death
30 Days
Amputation of Index Limb
9 Months
Target Vessel Revascularization (TVR)
30 Days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ORIONEXPERIMENTALAll subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.

Interventions

NameTypeDescription
Epic™ Nitinol Stent SystemDEVICEThe Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.
Anti-platelet therapyDRUGInvestigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial.
Anti-coagulation therapyDRUGAnti-coagulation therapy must be administered during the procedure consistent with current clinical practice.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Documented chronic, symptomatic iliac artery atherosclerotic disease (Rutherford/Becker category 1, 2, 3 or 4) * Lifestyle-limiting claudication or rest pain * De novo or restenotic lesions in the common and/or external iliac artery * Subjects with bilateral disease may have o...

Countries:United States
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Frequently asked questions about Anti-platelet therapy

What is Anti-platelet therapy used for in Iliac Artery Stenosis?

Anti-platelet therapy is used for the treatment of atherosclerotic lesions in iliac arteries, specifically for Iliac Artery Stenosis. It is being developed by Boston Scientific Corporation (BSX) and is currently in Phase 3 clinical development as an investigational therapy.

What does Anti-platelet therapy target?

Anti-platelet therapy targets platelet aggregation, which plays a role in the formation of atherosclerotic lesions. By inhibiting platelet function, it aims to reduce the risk of thrombotic events in patients with Iliac Artery Stenosis undergoing treatment.

Who makes Anti-platelet therapy?

Anti-platelet therapy is developed by Boston Scientific Corporation, a medical device and pharmaceutical company traded on the New York Stock Exchange under the ticker BSX. The company is conducting clinical trials to evaluate the therapy for Iliac Artery Stenosis.

What phase is Anti-platelet therapy in?

Anti-platelet therapy is in Phase 3 clinical development. It is an investigational therapy and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform further development decisions.

What clinical trials is Anti-platelet therapy in?

Anti-platelet therapy has one completed Phase 3 clinical trial, NCT00896337, titled 'EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries.' The trial enrolled 125 participants in the United States and evaluated the therapy for Iliac Artery Stenosis.

Is Anti-platelet therapy the same as EPIC Nitinol Stent System?

Anti-platelet therapy is not the same as the EPIC Nitinol Stent System. The EPIC Nitinol Stent System is a medical device used in the clinical trial NCT00896337, while Anti-platelet therapy refers to the drug treatment being studied in combination with the stent system for Iliac Artery Stenosis.