Texas Health Dallas - Institute for Exercise and Environmental Medicine - Women's Heart Health Laboratory

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Non-ST Elevated Myocardial Infarction

Coronary Artery Disease

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Lenzilumab

Agendia

Humanigen

M.A. Med Alliance

condition

allSponsorName

NAMSA

gender

Male

Female

overallStatus

Recruiting

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type

Interventional

Observational

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phase

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funderTypes

Industry

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All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA.

The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

SELUTION 4 De Novo Small Vessel IDE Trial

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SELUTION 4 De Novo Small Vessel IDE Trial

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