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NCT02229864 · ClinicalTrials.gov registry record · NA
Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
A NA study of Coronary Artery Disease and Coronary Disease, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT02229864: Completed NA study of Coronary Artery Disease and Coronary Disease, sponsored by Abbott Medical Devices.
NCT02229864 is a NA study of Coronary Artery Disease and Coronary Disease that has completed, run by Abbott Medical Devices. The registered enrollment target is 12 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02229864, a NA study of Coronary Artery Disease and Coronary Disease, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).
Conditions Studied
Interventions
- DEVICE Coronary artery stenting: Absorb BVS
Study Locations (2)
Arizona
- Scottsdale Healthcare - Scottsdale
Michigan
- Cardiac & Vascular Research Center of Northern Michigan - Petoskey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-05 |
| Est. Completion | 2019-10-01 |
| Phase | NA |
What the finished NCT02229864 record still lists
NCT02229864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Coronary artery stenting: Absorb BVS is the first listed.
NCT02229864 reports a single indexed study location in Arizona, Michigan.
Frequently Asked Questions
What is clinical trial NCT02229864 about?
NCT02229864 is a clinical study titled "Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions". 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 se...
What is the current status of trial NCT02229864?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2014-05. Estimated completion is 2019-10-01.
What conditions does trial NCT02229864 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Coronary Disease, Coronary Stenosis, Coronary Artery Stenosis.
What interventions are being tested in trial NCT02229864?
The interventions under investigation include: Coronary artery stenting: Absorb BVS (DEVICE).
Who is sponsoring clinical trial NCT02229864?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02229864 being conducted?
This trial has 2 study locations across Arizona, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02229864's enrollment target sits among peer trials
12 217th of 219 higher than 3 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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