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

NCT02229864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-03-12

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

Coronary artery stenting: Absorb BVS

* Scaffold diameters: 2.5, 3.0 and 3.5 mm * Scaffold lengths: 8, 12, 18, and 28 mm

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • David G. Rizik, MD · Scottsdale Healthcare, Scottsdale, AZ

  • Louis A. Cannon, MD · Cardiac and Vascular Research Center of Northern Michigan Petoskey, MI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-10-31
Completion
2019-10-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229864 on ClinicalTrials.gov