CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Coronary artery stenting: Absorb BVSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02229864
NCT02229864N/ACompleted
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ABSORB III RCT Pharmacokinetics (PK) Sub-study

Abbott Medical Devices·interventional·Posted Sep 3, 2014·Updated Mar 12, 2021

In Brief

A clinical study evaluating Coronary artery stenting: Absorb BVS for Coronary Artery Disease and 3 related conditions. Completed, enrolled 12 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 3, 2014
Enrollment StartMay 1, 2014
Primary CompletionOct 1, 2014
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.8 years ago

Interventions

Coronary artery stenting: Absorb BVSdevice

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