Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions

Completed · Not applicable

Conditions studied: Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis

In brief

The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only receive Absorb BVS with a maximum of two de novo native coronary artery lesions after implantation of the Absorb BVS. Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III RCT primary endpoint.

Key facts

Study ID
NCT02229864
Run by
Abbott Medical Devices
People needed
12
Starts
2014-05-01
Expected to finish
2019-10-01
Last updated by the study team
2021-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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